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1. Competence 1 34 Mainscreen Qualifiers Programs Printing Deleting Ci IM L I 2 ee Test j Cap ary electrophoresis ee ee Specie Tac FT lete No BSP ID BSP Number Title 53 Bspos Eryt 1 zu E ee T P L LE kb CAP Number Title ID MSS Number Tith EE PTS Het PTS en IC AB By clicking directly on a BSP CAP MSS reference number marked in blue you open a window which provides you further detailed information about the corresponding project In case there is an URL quoted you are directly led to the source document when clicking on the link Seite 40 von 65 Online Manual EDQM OMCL http www edqm eu omcldb Competence 1 34 Mainscreen Qualifiers Speciflers Programs Printing Deleting D 090 http www edam eu BSP List O omera rea BSP List BSP Number BSPOS1 yee Title Erythropoietin batch 3 2247 Test Method Article Reference Publication URL Sorting Group Chaman Sub Method Obvsciete BSP List ID BSP Num no Delete EL Add Record CAP List Fertig FoxTrick 1 ID CAP N rapp pioase select 10 add zj Add Record MSS List ID MSS Number Title please select to add zi Add Record PTS History PTS Yaar OCABR m For PTSs the years of performance are provided but no reference is made to the project number This decision was taken for data confidentiality reasons Also PTSs outside the EDQM program can be recorded MSS List D MSS Number Titis aseena a2. Seite 54 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The User Domain Providing New Accounts HOME OMCL COMPETENCES USER USER LOGOUT HELP OMCL administrators are allowed to provide new user accounts within their organisation Specific Searches within User Domain When clicking on User a search dialogue box opens which is only useful in case you have a lot of users registered within your organisation In that case you can search for the last name or the login email address wild card search This search function is more relevant for the EDQM system administrators as EDQM can query the list of all users registered in the database HOME DOMCE nanan COMPETENCES USER LOST HELF Search User Last Name a Login na Search Clear Show All Seite 55 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The User Domain Show All Function By clicking on Show All or alternatively by clicking on Search while leaving the search boxes empty you receive the list of users allocated to your OMCL In the given example there are 2 users registered ni D alsi Login Sts LastName alsi FirstName aks Organisation atsi ValidF om aie ValidUnt as 11 voaza Valise Eva Senta Laboratory of Arenal Healt 01 05 2007 Open Delete 1 nchard wate gedy eu Viento Richard European Direciorale tor fe Quality of Medicires 01012007 Open Delete Seite 56 von 65 Online Manual EDQM OMCL http www edqm eu omcl
3. Add Record PTS History PTS Year OCAGR O IT o Record Modified Date 27112007 Moditted Time 151255 Modified By richard wanko Sedam eu Created By richard wanko edqm eu Seite 41 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The Competences Domain Printing In this sub folder it is possible to print a standard format including all information related to a specific competence of an OMCL click on Print Record Competence Overview Hasinzc esen Qusalifieis Species Programs Printing Deleting Back to Litt Recon Last Met Record Record PPS 7 Previous Fial Record Seite 42 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The Competences Domain Deleting This function will allow you to delete a complete competence record of course only a record which has been established by your OMCL Before you can click on the Delete Record button you have to tick the respective box to activate the delete function Hamnscreen WJuald ers Filing Sy peel pears Programs Deketir aj l Bi E ves Iwant io delete this competence Delete Record Last Record Back to List Next Hecond Previous Record Fist Record Seite 43 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The Competences Domain add competences Add Competences Inserting a New Competence Add Record Search Show own competences P
4. OMCLs user cannot access the Delete folder folder is marked in grey and thus are not authorised to delete complete OMCL records not even their own set of data Seite 28 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The Competences Domain HOME OMCL UMFEIENUE ER LOGOUT HELP When clicking on Competences again a search dialogue box opens This is definitively one of the key functions of the database It allows you to search for competences available within the network Search Competence in OMCLS with Lab Category tere EUIEEA not searched SMS Covered cMotsearched M Run ace Ph Eur not searched Ea Se STORE Year oflast PTS not older than aan CAP Number es mE ES Animal not searched Product Class not searched x Manufacturer not searched Seite 29 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The Competences Domain General Search Fields Search Dialogue Box within Competence Domain Search Competence OMCL Code el in OMCLs with Lab Category notsearched O00 M EU EEA tere Test MethodsSub Method E QMS Covered notsearched M Run acc Ph Eur notsearched el OCABR notsearched 000 Year of last PTS not older than SS BSP Number RC _ CAP Number notsearched wl MSS Number notsearched wl Animal notsewched wl Product Class notserched wl Manufacturer notsearched wl S OWT competence
5. Lab Cat Provides information on the type of laboratories available within the OMCL Documents In this folder uploaded documents related to the respective OMCL can be found and downloaded within your own OMCL record you can upload new documents e g annual reports Print In this folder you have the possibility to print available information related to the respective OMCL in a predefined format Please note that Firefox allows you to print any page of the database if so wished Delete Via this folder a complete OMCL record can be deleted you are not allowed to delete any OMCL record not even your own record this can only be done by the EDQM system administrators Seite 16 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The OMCL Domain Saving Information IMCL 157 Contact Comments OMCLLabCat Documents Print Delete D Last Co onlormity Date azare MOL Code OMGL ATAGESB OC S S MCL Internal Code AGESPhamMe sts MCL Name Austrian Medicines Agency County Code usta O MCL Net Member Ful member v Tii mena A Admin Structure Direct OMCL Contact Area MS Type ISO 17025 v Wed Site gt ACL Document 0 Documents stored Modifed Date 1106 2007 Modsad Tine 164802 Modited By richard wanko Sedam eu rated By Nchardwanko Sedam eu Please note In case you switch between folders within the OMCL domain also applicable for the Competences domain all data which have been added or chang
6. Online Manual EDQM OMCL http www edqm eu omcldb The Competences Domain Specifiers Mainsc een Qualifiers Piogams Printing Deleting T ype Ph Eur Chapter Test Method Sor tng Group Sub Method Cbsotete Arenal D Species Name please select to add v Add Record Product Class C Product Class 27 Tick borne enceohalts vaccine mactvated Delete ern se Manufacturer D Manutactuner pease select to add v Add Record Mocd ed Date 2711112007 Modifed Time 10 13 41 a Zu dd ie nl ea fda oe Mmes Mie u oe s ds r eam bt nad TE GT law in ic RETA a aa In this sub section you can make links to animals product classes and manufacturer methods where applicable With respect to product classes preliminary the titles of the vaccine antitoxin or specific monographs of the Ph Eur are used e g Cholera Vaccine Please note Manufacturer references should only be made in very particular cases e g for vaccines which are tested in the course of the OCABR program according to a specific method of the manufacturer e g specific immunochemical methods Seite 39 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The Competences Domain Programs In this sub section you can link the defined test method sub method to OMCL Network programs such as PTS CAP MSS BSP and OCABR In case of BSP CAP and MSS the corresponding project title is provided
7. Printing g Deleting z Add Competence z Mainscreen Basic Setting Qualifiers Test Method Qualifiers Type a Qualifiers Sorting Group Qualifiers Sub Method 5 Qualifiers Levels z Specifiers Programs m Deletion of Attributes Specifiers PTS OCABR User Domain m Show All Search 7 Add User m Access Levels m Delete User g General Features u Search Sorting of Lists g Saving Information z Records E http www edqm eu omcldb Seite 65 von 65
8. fields QMS last assessment this should address the date of the last external assessment of your QMS against the standard ISO 17025 and respective OMCL guidelines either in course of an MJA starting from an initial MJA upwards or by another comparable external audit program Alternatively the QMS of the lab categories is considered as externally assessed if it is covered by the scope of accreditation document issued issues by a competent accreditation body Please put as date either the issue date of the MJA attestation if not available the last date of the MJA itself or the valid from date stated on the accreditation certificate Dependent on the scope of accreditation or the scope of the MJA within the lab category all methods all covered only parts of the methods partially covered or no methods might be QMS covered In the latter case this field should remain empty In the comment box next to the lab category you can add additional information related to the QMS coverage of the respective lab category Comment Boxes under OMCL Lab Cat Folder In case of a blank MJA an MJV or a tutorial you can add this piece of information in the corresponding specific comment fields or in the general comment field Lab Category Additional Information In that case the QMS coverage field must remain empty In the general comment box on the bottom end of the folder you can also provide additional information about any of your lab cate
9. http www edqm eu omcldb The Competences Domain Qualifiers Sorting Group Using Ph Eur reference Provided you know the Ph Eur reference number for a general test method you can alternatively enter this number under Ph Eur Chapter and consequently get the corresponding test method Please note The nomenclature of the test method sub method follows the convention of the European Pharmacopoeia wherever applicable In case the test method and the combination of test method sub method have different Ph Eur references the latter overrules the former one Drop Down Sorting Group In the present case you have chosen HPLC as test method In a next step you may select a Sorting Group in order to shorten the list of corresponding sub methods For some test methods different types of sub methods might be attached Taking the example of HPLC this method can be assigned to a specific detector e g DAD a specific coupled technique e g HPLC MS a specific technique e g chiral column or a specific method e g acetic acid in synthetic peptides i Competence UM iD E OMCL OMCL AT_AGES B Type SZ Ph Eur Chapter GERS pu Test Method Chromatography Liquid high pressure HPLC ts me ee Soning Group rl Zub Melia Cousted Technique Chee tice Obsolete Gonaral Species Method Scie Technique Competence Level TT Ta pp aes Frequency Level a Boot tatin eng ne GMS Covered B Lasi PTS Year
10. j 4 i i iiie Iploaged By LI ping ceed Annes Belgian OMGL AR 05 pet m chatal gph go be 1102007 nm charted righ Ago be ble tire ard l Ourchsuchen Cel CL C me 2 Documents saed Mode La 1110007 Hocker Time 120211 Modted By m chatal oh ov be Created By Previous Record i al nichardiwanko Bedam eu In order to download a document simply click on the document title and your computer will give you further instructions how to save the file e g on your desktop Oe Save As Save As Annex I Belgian OMCL AR 06 pdf f gt Where i Desktop Format Portable Document Format B Caneel CE Seite 26 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The OMCL Domain Print Screenshot The Print main screen has the following structure OMCL 31457 OMCL Mainscreen Contact Comments OMCLLabCat Documents Delete SACL Overview witout Competences OMCL Overview with Competences MOL Declaraton Conformity OMCL Document D Document stored Modifed Date 11062007 Moctied Time 1648 44 Modited By ichardwanko Gedam eu Created By ichard wanko Sedam eu Next Record Last Record Back to List Save Print Options There are three standardised print options Each OMCL can print its own record and the records of all other OMCLs inclusively or exclusively the corresponding competences by activating the respective print button In addition only the conc
11. those competences which are allocated to your OMCL in the example above you see the list of competences from the view point of a read write user from the Austrian OMCL AGES B The Delete buttons of other OMCLs remain deactivated grey Seite 34 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The Competences Domain Abbreviations used in the Competence List Some further information concerning the competence list You can get information about what stands behind the used abbreviations BIO BIO PC under Type A B G D ne under Frequency Level 0 4 2 cs 4 under Competence Level and A P M under Specifiers by clicking on the respective symbols This will open an extra explanatory window as show exemplarily for Frequency Level Competence 585141 OMCL z Test Method A7 Sub Method Alsi Type AH Freg vi AH Comp hi A5 Ph Eur JH OMS Prog A Spec Six ee ne ann l um http www edam eu Frequence Level Lege MC rot El RSS CH i OMCL AT_AGES B aeg einen method BIO A Frequency Level Are j OMCL AT_AGES 8 ed ubunefced ine based o angra Infcrmation BO Aa A Spa testing less than 2 times per year Say s EENE EET ii B rarely less than 12 times mer year OMCL AT_AGES 8 Abnormal toxicity Bid Al es ae soins aid oosaslonally once a month on Array ol diphiharia er i OMCL AT_AGES B Assay bio Col eunureveccine Mate BIO Aj E Qurrenty at least twice a week olan aT agee p Aka oflst
12. within this domain same is applicable also for the Competences and User domains Seite 14 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The OMCL Domain OMCL detailed Information Deletion of OMCL records i p jose Git af CHACL Code sie OCL Name m County a Ter il CWC NeiMenber 41m OM GL AT_AGHES Ei Batian Heie Agency Aia kia Wanna Fil rriar er Open OMCL AT_AGESC huakin Mecicines Agency fas fia Werra Full member Open LA Tail heaps Soc Administ wien Laboralores Sue rae CNET a Aol bed Open OMCL BA_ MOC Ins tute for Medicines Quaity Conia Bosna Hermogowna Sarajewo Full member Open OM CL BE _PH 6 Beenie Felle Pubs Haah Section Eloi Serena Beige Erig Faull member Open CMCL HE PH 5 Saar Feii of Pubic Health Medicines Section Bian Ela ys sms Fula member Open OM L BE VAR Veterinary and Agrochemical Research Cente Beige Lee Ful member Open OMCL BG_BOA Bulgarian Drug Agency Buijara Soia Ful member Open Haba ee ray Bernie ie ier Gar ot Vein y OM CL BG_KCve z saad 5 a a ua Elan So Fal member Open M dcrial Prod OMEL CA BOTO Bios and Genetic Thermes Direciorais yada Orhan cerner a ed You can click on any Open button to access to detailed information concerning the respective OMCL You are not allowed to delete any OMCL record on your screen there does not appear a Delete button In case you click on the Open button of your OMCL you are allowed to change data within your own rec
13. Clearing a Search for Competence In order to start a new search you can click on the button Clear which will clear all search fields including data from a previous search Of course data can also be deleted manually step by step by manipulating the fields individually Search for own competence If you enter your OMCL code into the OMCL Code search field and then activate the Search button while keeping all other fields blank you will get a list of all competences related to your OMCL The same is applicable when you activate the button Show own competences Pre Selection Search for Competences In a number of fields you can make pre selections by choosing from a pop up menu applicable for all fields with an arrow symbol on the right hand side Search for Test Method Sub Method In the field Test Method Sub Method you can enter a combination of words or part Seite 30 von 65 Online Manual EDQM OMCL http www edqm eu omcldb of words and the system will search within the test method and the sub method fields for combined hits similar to a Google search Please note The search under Competences allows more flexibility in comparison to the wild card search described under OMCL Search for PTS Information For a Year of last PTS not older than search you add a year code e g 2005 or 05 and all competences with attributed PTSs performed in 2005 or later will be displayed in a list Seite 31 von 65 Onl
14. Conformity Date triggered by the conformity procedure described in the respective section In the field OMCL Internal Code you can add the code which is used within your organisation to identify your OMCL this code might also form part of in the official OMCL code e g INFARMED NAM etc The field Admin Structure provides information whether the contact point of an OMCL is directly located at the OMCL level Direct OMCL Contact or communication runs via the corresponding authority Central Authority Contact which is the case in some few member states Seite 19 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The membership terms full member and associated member follow the present definition of the GEON Terms of Reference The fields QMS Type and QMS Other should provide information about the Quality Management System which is in place at the OMCL The first reference should preferably be ISO 17025 Other standards can be quoted in the text field QMS Other Provided that you have added an URL address for your organisation a link will be established which leads users automatically to the corresponding web site In case you are updating information in this screen don t forget to save them by clicking on the Save button Seite 20 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The OMCL Domain Contact Screenshot The Contact main screen has the following structure MOL 1457 O
15. D Zaren Fun ae Ph Eur E Modified Date Modified Tiet 00700 Modified Bry Created By Seite 48 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The Competences Domain Qualifiers Drop Down Sub Method Competence 00O Deleting D g OMCL OMOL AT_ACES B v Test Menod Chromatography Liquid high pressure HPLC v Sorting Group Detector x Sub Method m Obsolete Chemical reacton toaty Diode array DAD Competence Level Electrochemical ECD Evaporatve fight scattering ELSO OMS Covered Fluorescence FLD Other detector Comment Polar im es Pulse Amperometric PAD Retactve index AD UV Vis adsorption spectroscopy ed wavelengh Modited Date Modibed Time 000000 Modited By Created By In the present example you have selected detector as sorting group and hence come to a list of possible detectors dedicated to HPLC from which you can now choose the required one Please note In case you have not selected a Sorting Group the corresponding sub method list for instance of HPLC will be much longer and more heterogeneous as all possible attributes are considered Seite 49 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The Competences Domain Qualifiers Levels Drop Down Attribution of Qualifiers Let s assume you have selected Diode array DAD as corresponding detector You can now also define qualifiers by choosing from pop up lists or by clicking on the respective tic
16. Database Manual Ease of Use Depending on the way you work there are different possibilities to find a specific topic or key word Sitemap A menu of sub pages to the used navigation points is located on every single site in the left column and provides an overview of the topics of the online manual The complete sitemap is provided in the main navigation Topics of the online manual are based on the directory of the print manual which has been handed out during the training courses Most of the topics navigation points of the online user manual are explained on single sites where detailed information will be provided General Features General functions applicable for the three domains OMCL Competences and User are summarised in the sub navigation General Features Enlarge Graphics Graphics will be shown in real size by clicking on them Firefox Please note The OMCL database is optimised only for the use of the browser Firefox Please download and install the latest version of Firefox from the Mozilla website at http www mozilla europe org Seite 4 von 65 Online Manual EDQM OMCL http www edqm eu omcldb How to Access the OMCL Database Starting Page Browser Preference Please open the browser Firefox and enter the URL http www edqm eu omcldb The following screen appears which is the starting page of the database amp On the starting page you will find a note requesting you t
17. EDQM OMCL Printout Online Manual OMCL Database http www edqm eu omcldb Headquarter EDQM Council of Europe 7 allee Kastner CS 30026 F 67081 Strasbourg FRANCE Online Manual EDQM OMCL http www edqm eu omcldb Inhalt Online Help How to use the OMCL Database Manual Ease of Use Sitemap General Features Enlarge Graphics Firefox How to Access the OMCL Database Starting Page Browser Preference Login Dialogue Box Username Password Changing the Password Errors while changing Password Password forgotten Log Out Navigation What are the main domains and folders you will work with as an OMCL User Top Level Navigation Domain Tool Bar The OMCL Domain Search Functions Search Dialogue Box within OMCL domain OMCL detailed Information Deletion of OMCL records Records Structure Detailed Records of OMCLs Sub Navigation Navigation Rider Saving Information Switching between Records Information about Modification Position of Record OMCL Mainscreen Screenshot Working within your own OMCL Domain Contact Screenshot Contact Details Comments Screenshot Additional Information under Comment Folder OMCL Lab Cat Screenshot Additional Information Documents Screenshot Uploading a Document Downloading a Document Print Screenshot Print Options Delete Screenshot Delete complete OMCL Record The Competences Domain General Search Fields Search Dialogue Box within Competence Domain Search in Comb
18. MCL Mainscreen Comments OMCLLabCat Documents Prim Delete a ACL Cod COMCL Name Man OMCL tact Tite FrstName eaen U LastName Lackner Emal tiedich lackner ages at mail to fnedrich jackner ages at Main QA Contact Tite Mr nio FratName Klaus Last Name Stuewe Em Haus suce Gages at mail to klaus stuewe ages al MCL Document 0 Documents stored Modted Date 11052007 Modited Time 164802 Mod ed By ichardwankoe Gedam eu Created By nchardwanko Sedam eu Le od ord Next Record Last Record Back to List Save Contact Details Your main contact person for the OMCL and QA activities are added in the respective fields under this sub section The attached email links will automatically open your mailing system link has to be established once on your computer and you can write immediately an email to the respective address In the free text fields of the section you can add additional information e g about another contact point a general email address etc In case you change data and forget to click the Save button they will get lost as soon as you switch to another folder Seite 21 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The OMCL Domain Comments Screenshot The Comments main screen has the following structure OMCL Mainscreen Contact Comments OMCL Lab Cat Documents Prnt Delete 20 Last Conformity Date mm OMCL Code OMCL ATAGESE t OMCL Internal Code AGESPhamMed 0 JMOL Name Aus
19. anus vaccin ax technique available but test currently OMCL AT_AGES B ra ortod Challenge best ECO A not partorrned OMCL AT_AGES 8 Assay bo Animal 1651 BIC Aa Below other abbreviations used in the competences list are explained Type BIO Biological method without involvement of animals BlO Biological method with involvement of animals PC Physicochemical method Competence Level 0 No information provided 1 Able to perform tests using a given technique method 2 Able to modify optimise an existing method 3 Able to construct new methods 4 Detailed knowledge of physicochemical and or biological principles and mechanisms involved in the technique method Specifiers A Animal P Product Class M Manufacturer Seite 35 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The Competences Domain Detailed Records of Competences An individual competence record includes 5 sub sections folders After opening you will reach the mainscreen of the competence record All other folders are visible in the riders bar which is located at the top end of the page Competence 7 55 Mainscreen Qualifiers Specifiers Programs Printing Deleting Type Tesi Mefvod Sor tn g Gr oup Sub Method Obsolete Competence Level No informaton provided v Frequency Level Spot testing v OMS Covered u Last PTS Year N Comment Run ace Ph Eur a Modted Date 271112007 Modified Time 101341 Modted By nchardwa
20. ast Record button Information of Modification Record Tracking You will find at the bottom end of each folder in the OMCL Competences and User domains information about the last data modification date the last modification time and an identifier email address of the person who created the complete record and who modified existing data within a record the last time OMG Document Documents stored Mockted Date 11062007 Modsed Time 16 4802 Mocdted By mhardwarko Geden eu r a By nchardwarnkoe Sedam eu Position of Record In the upper left corner of the screen you find information about the position of the record within the respective domain In the example given below you are under domain OMCL in the first out of 67 OMCL records in the folder OMCL Mainscreen This applies for the domains OMCL Competences and Users Seite 64 von 65 Online Manual EDQM OMCL Detail Sitemap OMCL Online Manual Sitemap HOME OMCL COMPETENCES USER LOGOUT HELP Online Help gt Database Access Username Password a Password Change Password Errors E Logout n Navigation OMCL Domain Search Functions m Deletion of Records m Records Structure a Saving Modifyin Mainscreen m Contact Comments OMCL Lab Cat m Documents 7 Print u Delete Competences Domain 2 General Search Fields a Combined Search Fields n Overview m Abbreviations m Detailed Records g Mainscreen Qualifiers 7 Specifiers Programs
21. ative Client domain back end and can be enlarged at any time upon request the same is applicable for any other pop up lists of the database Competence 0 56 P ml ng Deleting O O00 OMCL OMCL AT_AGES B v Type v Ph Eur Chapter nues a Sorting Group ine serum album Buffered plate eK test Rose Benga Tes RBT Sup Method Cl esterase inhibitor E la Calcium in adsorbed vaccines Obsolete Capillary electrophoresis are Carbohydratesssiaic acid Chembuminescence analyser NO NO2 Chewing gum medicated drug release fom Competence Level Chromatography Gas Sc Og quid convertors en Liquid low pressure NN Comment Chromatography Paper PC Chromatography Size exchkision SEC Chromatography Thin kayer TLC Chromatography Thin fayer high performance HPTLC Croutar dichroism Clarity and degree of opalescence of tqusds CO determinaton Method I CMS Covered Modted Date Modited Time 00 00 00 Modsed By Created Sy rest Hecord Previous Hecod Next Recor Last Record Seite 46 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The Competences Domain Qualifiers Drop Down Type You can shorten the list by pre selecting under Type the attributes Physicochemical Biological Competence 0 56 Promame Panties Deleting OMCL OMCL AT_AGES B v D Type Ph Eur Chapter Test Metod v v Soring Group Sub Mehod v Odeo No Seite 47 von 65 Online Manual EDQM OMCL
22. cines Agency Country Code ET y OMCL Net Member Fulmember lt wM To a Yd Admin Structure Direct OMCL Contact M Area u OMS Type ISO 17025 OMS Offer OMCL Quality Assurance Documents O O OO 22222 Posta Address 1160 Wen Possingergasse So Vieling Address 1160 Wien Possingergasse 33 Vied Site RS j gt Soyg8 TVJ y z _e _ _ a OMCL Document 0 Documents stored Modibed Date 1106 2007 Modsed Tine 164802 Modited By richard wanko Sedam eu reated By Ic hardwanko Sedam eu Indication of Saving Status Whenever an Add record or Save button is activated the successful saving of data or its failure is indicated on the upper right hand of the respective folder this applies to the OMCL Competences and User domains Competence 3 37 Ino record was cre ios evcceneful Specifiers Programs Printing Deleting iO LE OMCL OA N Seite 63 von 65 Online Manual EDQM OMCL http www edqm eu omcldb General features in the OMCL Competences User domain Records Back to List Button In order to go back from the detailed folders to the list please use the Back to List button Switching between Records On the bottom end of each screen in the OMCL Competences and User domains you find buttons which allow you to switch between different records from a selected list You can switch between the corresponding folders of each record by using the First Record Previous Record Next Record and L
23. db The User Domain Adding a New User lf you want to add a new user to the list click on Add record which will open a window where you can now start entering all necessary information of the user For example as OMCL administrator of the Austrian OMCL AGES B you can only allocate new users to this organisation User Of2 Orgaresaton OMCL AT_AGES B AustlanMedcines Agency M 0 EEE Tite Frot Name pU LastName Ema PO Righigroup D ee ad From Ss Vaid Unt al Password Expired SSS zz Generate And Send Password a Seite 57 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The User Domain Access Levels User Access Levels There are three levels of OMCL access rights which you can provide OMCL admin OMCL read only and OMCL read write It should be stressed that the system allows to provide the access right OMCL admin to more that one user within an organisation Usor 0 n TEE EEE Organisation OMGL AT AGES B Austian Medicines Agency DR a ef in Titig Firsi Name Lasi Here Eman Rightgroup ID Valid From Valiel Lentil Password Expired Gens And Send Password E Username Password The email address which you enter into the corresponding field will be at the same time the username of the new user For that reason you should always use personal email addresses and no collective addresses The email address you enter is case insensitive whichever co
24. ed in the folder you have just left will get lost if you forget to click the Save button This is not applicable for information added modified or deleted with an Add record Edit record and Delete button In order to go back from the detailed folders to the OMCL list please use the Back to List button The same principle also applies for the OMCL and User domain Switching between Records On the bottom end of each screen you find in addition buttons which allow you to switch between different records from a selected list You can switch between the corresponding folders of each record by using the First Record Previous Record Next Record and Last Record button the same principle is also valid for the OMCL and User domain Seite 17 von 65 Online Manual EDQM OMCL http www edqm eu omcldb Information about Modification In addition you will find at the bottom end of each folder information about the last data modification date the last modification time and an identifier email address of the person who created the complete OMCL record and who modified existing data within a record the last time this also applies to the Competence and User domain The number of documents attributed to an OMCL record is provided on each folder of the OMCL domain Modted By mhardwanko Gedem eu r a By nchardwarnkoe Sedam eu Position of Record Finally in the upper left corner of the screen you find information about the pos
25. erned OMCL can print its own OMCL Declaration Conformity Document which it has to sign and send back to EDQM With this declaration the OMCL confirms that all data of the database are up to date An official request to send this declaration will be made on a yearly basis by EDQM Please note The list of competences is sub divided in three categories physicochemical tests biological tests involving animals and biological tests not involving animals The test methods in the standard prints are sorted within these three categories in alphabetic order This should allow an easier distribution of the prints within the OMCL e g for a data validity check Seite 27 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The OMCL Domain Delete Screenshot Contact Comments OMCL Lab Cat Documents Screen from a non authorised users Delete complete OMCL Record JMOL 3157 OMCL Mainscteen Contact Comments OMCLLabCat Documents Print Tepe je if yOu ue t 4e ete i 5 MC pese seen Le cher bo x 55 day frm LJ Yes want to delete this OMCL Delete Record OMCL Document 0 Documents stored Modified Date 11062007 Mocted Tine 1648 44 Modified By richard wanko Secom eu Created By nchard wanko Secam eu The delete sub section allows authorised users EDQM system administrator to delete a complete OMCL record Before the Delete Record button can be activated the box Yes want to delete this OMCL needs to be ticked
26. f you have forgotten your password a new one can be sent to you by automatic email For this purpose you have to enter your username in the login field and click on the button Password forgotten You will receive an automatic message on the top end of the dialogue box informing you that A new password has been sent to your email address Seite 9 von 65 Online Manual EDQM OMCL http www edqm eu omcldb How to Access the OMCL Database Log Out HOME OMCL COMPETENCES USER Please note If you do not use the database for longer than 30min the system will logout automatically and you will be asked to re enter your username and password again after you re start working with the database You can actively log out by clicking on the Logout button which you find on the right hand side of the domain tool bar of the starting page Seite 10 von 65 Online Manual EDQM OMCL http www edqm eu omcldb Navigation What are the main domains and folders you will work with as an OMCL User On the top level navigation of all database screens you find a tool bar including a number of features PONE et DOMPETENCES USER LOGOUT HELP Welcome ORAL LORACL HELP OMPETENCES COMPETENCES Heb SER USER Help Supported Brow ters Meuse note thal Po ONCL database L Gelee tor Frais Pretox te the orty browser cirrertiy supported by the server Pease Gowrioed ond maiali the latest veroon of Fretox tom the More webete at http www
27. gories e g your intention to open a new type of lab in the near future Seite 24 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The OMCL Domain Documents Screenshot The Documents main screen has the following structure OMCL 167 OMCL Mainsc een Contact Comments OMCL Lab Cat Print Delete D Last Conformity Date OML Code OMCL internal Code OMCL Name D Tite Uploaded By Upload Durchsuchen Add Record OMCL Document 0 Documents stored Modited Date 11062007 Modifed Tre 16 48 02 Modied By chard wanko Sen eu Created By Nchardwanko Sedam eu rast Record Previo Record Next Record Last Record Back to List Save In this sub folder you can upload any kind of documents doc xis pdf jpg etc or can download documents stored by other OMCLs in their records Uploading a Document In order to upload a document you first browse within your computer click on the Browse button open the respective file and then activate the Add Record button Please note By clicking on Add Record the document will already be saved DHOL Mainscreen Contact Loser OMCL Lab Cm Doczumen a Print Delete cing ye ae ge ge sds dies dies die dis diac Seite 25 von 65 Online Manual EDQM OMCL http www edqm eu omcldb Downloading a Document n dii A at j OMCL Mainscreen Contact Comments OMCL Lab Cat Doe Print Delete Li Lat Colt by Tin RE MEL Code T E DH CL infernal Code Te ay
28. ine Manual EDQM OMCL http www edqm eu omcldb The Competences Domain Search in Combined Search Fields At the bottom end of the search screen you find a number of search fields which allow a combination of pop up menu and free text search You can either make a general search for competences which are e g allocated to the CAP program or the opposite all competences not allocated to the CAP program BSP N umber not searched lt w CAP Number MSS Number yes no Animal not searched v Product Class not searched v Manufacturer not searched v or you can specify a particular CAP program by entering either the CAP number or parts of the CAP number or the name of the related study A combination of CAP number and study name in one step is not possible BSP Number notserched Ml CAP Number notsearched ler Cis MSS Number notserched wl Animal notserched wl Product Class notserched wl Manufacturer notserched i Seite 32 von 65 Online Manual EDQM OMCL http www edqm eu omcldb BSP Number notsearched 3 CAP Number notsearched Mabteral MSS Number notsearched 2 mi Ds Product Class notsearched m f vu Manufacturer notsearched M ne When adding a text in the free text fields please make sure that the corresponding pop up field is either put on not searched or yes The same search principle applies to all other
29. ined Search Fields WON DUNN HP A A A HFA y O e e e he m e m e e e W N NNNNNNNNNNNNNRPRP RPP RP RPP BP H COON NDU U1 NN N PR PO WON ND OD U W N O WO UJ N Seite 2 von 65 Online Manual EDQM OMCL http www edqm eu omcldb Print List 33 Competence Overview 34 Abbreviations used in the Competence List 35 Detailed Records of Competences 36 Mainscreen Qualifiers 37 Specifiers 39 Programs 40 Printing 42 Deleting 43 Add Competences Inserting a New Competence 44 Mainscreen Basic Setting 45 Qualifiers Drop Down Test Method 46 Qualifiers Drop Down Type 47 Qualifiers Sorting Group 48 Qualifiers Drop Down Sub Method 49 Qualifiers Levels 50 Specifiers Programs 51 Deletion of an Attribute 53 Specifiers PTS OCABR 54 The User Domain 55 Providing New Accounts 55 Specific Searches within User Domain 55 Show All Function 56 Adding a New User 57 Access Levels 58 User Access Levels 58 Username Password 58 Validity of Access 58 Password Policy 59 Deleting User Records 60 General features in the OMCL Competences User domain 61 Search 61 Activating a Search Search Button 61 Sorting of Lists 62 Saving Information 63 Records 64 Back to List Button 64 Switching between Records 64 Information of Modification Record Tracking 64 Position of Record 64 Detail Sitemap OMCL Online Manual 65 Seite 3 von 65 Online Manual EDQM OMCL http www edqm eu omcldb Online Help How to use the OMCL
30. is described under OMCL see Information about Modifications Seite 37 von 65 Online Manual EDQM OMCL http www edqm eu omcldb Accessing Corresponding Competence Folders The corresponding folders of other competence records of a selected list can be accessed by using the respective buttons located on the bottom end of the screen similar to the OMCL records Saving of Competence Records Modified Dat 2111172007 Modted Time 10 13 41 Modibed By richardwanko Gedam eu Sreated By ichard wanko edqm eu F ONE P NC With respect to saving updated records the same principles apply as described in the OMCL domain For both the specifiers Animal Product Class Manufacturers and the programs MSS BSP CAP data are selected from pop up menus As soon as an attribute is selected and the button Add Record is activated the data are saved You do not need to click on the Save button on the bottom end of the screen in addition This is also applicable for PTS history data entries In any other case if changes have been made in a record the Save button needs to be clicked before leaving the sub section otherwise the changes get lost Indication of Successful Saving Whenever a Add record or Save button is activated the successful saving of data is indicated on the upper right hand of the respective folder this applies not only for the Competences domain but also for OMCL and User Seite 38 von 65
31. ition of the record within the respective domain In the example given below you are under domain OMCL in the first out of 67 OMCL records in the folder OMCL Mainscreen The same applies for the domains Competences and Users In the next sections you find the screen shots of all above mentioned sub section folders providing detailed information about their content and their functionality Seite 18 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The OMCL Domain OMCL Mainscreen Screenshot The OMCL main screen has the following structure IMCL 1157 Contact Comments OMCLLabCat Documents Print Delete a Sontormity Date 72008007 MOL Code ONGLATAGESS MCL Internal Code AGES P harmMed ts MOL Name Austrian Medicines agency County Code asa O MOL Net Membe Full member v Town Verma S Admin Structure Direct OMCL One M Area ee MS Type ISO 17025 v Postal Address 1160 Wan Possingergasse So Lie Id Ai ass 1160 Wen Possingergasse 38 Vied Sie EE Mol Document 0 Documents sired Modbead Dat 1106 2007 Modted Tine 164802 Modited By richard wanko Sedam eu stated By kharGwankto edam eu ME Ho Working within your own OMCL Domain lf you enter your own OMCL record you will be allowed to change any data within this record with the exception of ID identity code provided automatically by the system the OMCL code can be changed by the EDQM system administrator only upon request and Last
32. iy Covered DON0QCA and biotech vet 07062004 Pa tally Covered Blood and blood products 07062004 Pas taly Covered Microbiology 0706 2004 Pot taly Covered Sera Vacones human 07062004 Par baly Covered please Select to add v w Lab Category Ad AR i Comments Docu t D Documents stored Mocted Date 11062007 Modified Time 164802 Modted By nchardwanko edam eu Created By nchardwanko Sedam eu Additional Information Inthe lab category folder you find detailed information about the lab categories types of laboratories available within the respective OMCL Adding Editing Records Please note In case of adding a new lab category or changing an existing record by clicking on Add Edit Record you have already saved the changes You don t need to click the save button again this is only necessary when entering text or making changes in the comment field Lab Category Additional Comments Update Existing Data If you want to update already existing data of a lab category please select the corresponding lab category again from the pop up list and edit the corresponding fields For entering a date in the field QMS last assessment any European convention using only figures for expressing a date e g 12 11 04 12 1 1 06 will produce the result 12 11 2006 By clicking on Add Edit Record the old set of data will be overwritten automatically Seite 23 von 65 Online Manual EDQM OMCL http www edqm eu omcldb Concerning the
33. k boxes Competence Level Frequency Level OMS Covered Last PTS Your Comment Run aoc Ph Eur Freezing and Defreezing of Test Method Sub Method Records If you finally click on Add Record the upper part of the screen including the core test method information turns into grey and is frozen In order to defreeze the test method information the button Change Test Method which is located below the Sub Method field has to be activated Type Ph Eur Chapter Test Method Sorting Group Gotector EEE Sub Mahad Disda array DAD bal Obsolete No Change Test Method Seite 50 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The Competences Domain Specifiers Programs Attribution of Layer Specifiers You can now attribute specifiers and programs to your test method sub method where relevant by opening the respective folders which are now activated they appear in grey as long as the test method sub method is not validated Competence 27 ID OMEL I Type Ph Eur Chapter us J Test Method SS m Goring Group RE NE EN NN EN I TS Sub Method Ob malate Zangen Lowel La Frequency Lawi Freer j OMS Covered a Last PTS Year Comment Fun ace Ph Eur E Moditind Dais 22012008 Modified Tire 150328 Meditied By bgm sorm mimea Cresied By es shorm mulienediacn The specifiers Animal Product Class Manufac
34. licking on the Clear button or by deleting them manually step by step OMCL List In case you want to see the complete list of OMCLs please click on Show All You will obtain the same result by leaving all search fields empty and activating the Search button This will lead you to the following list Seite 13 von 65 Online Manual EDQM OMCL http www edqm eu omcldb COL Gre OMCL Cade sie OCL Name m County m Tor as OMCL NetMenber 11m OMOL AT AGES E farrier ecko Agency hapa Fries vera Fii roenn beet Open OMOL AT_AGES C fashion Medines Agency Astia Wares Ful member Open OMC Tal eres oc Alain Laborakenes Bea Ta Bape ue Open OMCL BA_IMGC Insitute tor Medicines Quadty Control Bosna Hergowna Sara Ful member Open OMCL BE_PH 6 Scene yiii Pubi Health Section Benkogiecal Siadar disain Beigi Fi cas Full membe Open OMCL BE_PH C Scenic stile al buble Heat Mecicnes Sector Eigen Brusse Fu member Open OMOL BE VAR Weleer y and Agrochemical Research Genter Beko Lil Full member Open OMCL BG_ BOA Bulgarian Drug Agency Edgar Sota Full member Open OMCL BG_KIVe eb nrg envies Pei for Conka of Veterinary Dujara Sla Ful member Open OMCL CA_BGTD Biologics and Genetic Therapess Directorate arada Otia Associated Open The list can be selected in ascending or descending alphabetic order by clicking on the respective arrows next to the column titles In the upper left corner you get information about the number of records available
35. mozie europe oro Thara you for your undertianding Top Level Navigation Domain Tool Bar Home With the button Home you can at any time go back to the starting page OMCL The button OMCL allows you to access the general information about the OMCLs of the Network Competences The button Competences leads you to detailed information about the testing activities of the member of the OMCL Network User In the domain User you can define access rights admin read write or read only for all OMCL users within your organisation Logout The Logout button is the recommended way how to leave the database Help The Help section includes a comprehensive description of the database In the upper left corner of www edgm eu omcldb online help is provided The question mark leads you to the respective information Mail Support Finally questions which cannot be found in the user manual help section can be sent to the following general email address omclnet edqm eu and will be treated by the DBO colleagues dedicated to this database project Seite 11 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The OMCL Domain HOME _OMCL COMPETENCES USER LOGOUT HELP When clicking on OMCL a search dialogue box opens OMCL Search OMCL Code notsearched OMCL name OMCL internal code fj jf County ETC Tone SS OMG Net Mener TC Le Can Crus m Search Clear Show AN Seite 12 von 65 Online Manual EDQM OMCL ht
36. nko Sedam eu Created By richard wanko edam eu Seite 36 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The Competences Domain Mainscreen Qualifiers L Lompetence 120 Specdiers Progams Punting Deleting Type Tes Mefwo Met ate mpeienoe Leyo requency Leve OMS Covered u Last PTS Year CE Comment Run ace Ph Eu Mochied abe 2771 1200 Mod tex Time 10 13 41 Modted By nchardwanko Se dom eu Created By richard wanko edam eu This folder includes the core test method information and information about the so called qualifiers competence level frequency level PTS reference QMS information Ph Eur reference Please note If the box QMS Covered is clicked this indicates that the respective test method is covered by a QMS system which has been externally assessed for definition see chapter OMCL Lab categories By ticking the box Run acc Ph Eur you indicate that the method is run according to the European Pharmacopoeia The Last PTS Year information is triggered by the entries in the folder Programs The note Obsolete is triggered by the EDQM system administrators via the Native Client part In case a Ph Eur method becomes obsolete this is automatically indicated in the respective competence record The Native Client is a part of the database which is not accessible by OMCL users where e g the content of pop up menus are defined Record Tracking Record tracking works similar to what
37. nvention you use capital or small letters the password will be recognised by the system as username The system will not allow you to enter a new user record without defining an email address already at this stage Validity of Access You can also define a start date Valid From and end date Valid Until for limiting the access to the database If this option is kept open the date of creation of the record by activating the Save button will be taken as Valid From date and the Valid Until date will remain empty Seite 58 von 65 Online Manual EDQM OMCL http www edqm eu omcldb Password Policy Finally when activating the tick box Generate And Send Password followed by clicking on the Save button an automatic email will be sent to the email address of the new user informing him her about the password At the same time the Password Expired field shows the date when the password was delivered This is the trigger which forces the new user when first entering the database with the received password to change it immediately Please note that no fixed time frame is defined within which the new user has for the first time to enter the database and change the password Nevertheless all passwords will expire after one year As soon as the password has been changed the date of next password expiry will be shown in the respective field After the expiry date of the password the user will be asked automatically to rename his her passw
38. o use Firefox as standard browser while working with the database Please note It is very important that Firefox is used as with any other browser you might not be able to access Login Dialogue Box In order to open the registration dialogue box you have first to activate one of the domains listed in the tool bar Click e g on OMCL and the following dialogue box opens TT U ch n e Passwor d Password forgotten Seite 5 von 65 Online Manual EDQM OMCL http www edqm eu omcldb How to Access the OMCL Database Username Password Please enter now your username and password Your username is identical to your email address Concerning the password please use the one that you have received via the automatic email system addresser omcinet edqm eu Below an example on how this automatic email looks like is provided e Receipt of new password europarat O Ne O E Mail s l schen ist Werbung Antworten Analle Weiterleiten Drucken Von Richard Wanko Betreff Receipt of new password Datum 28 Februar 2007 22 05 01 GMT 01 00 An Bj m Senti Antwort an Richard Wanko Please find enclosed your new password to be used to access the OMCL inventory database Your password reads as follows Qqsc8f24 You can modify your password by using the Change password function Please note that the username is not case sensitive You can use capital or small letters and the sy
39. ord the next time he she tries to access the database Please note OMCL administrators will never know the password of the users for whom they have created an account The same is also applicable for the system administrators at EDQM It is not possible to allocate a user to more than one organisation e g an OMCL user defined by the email address from the Austrian OMCL can only get read write access to either AGES B or AGES C but not to both at the same time This should be considered when organising the database maintenance within the OMCLs respectively when defining a OMCL record Seite 59 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The User Domain Deleting User Records As OMCL administrator you can delete a user record within you organisation by clicking on the respective button It is even possible for an OMCL administrator to delete another OMCL administrator if necessary A window will open which will ask you to confirm by activating on the respective box if you really want to delete the record similar approach as e g for deletion of an own competence record UserDetail Delete LJ Yes Iwan io delete ihis use Finally it should be noted that you are not authorised to delete your own record You can activate the delete button but in that case the following message will appear You can t delete your own record With this principle it is not possible to delete b
40. ords The example in the next section OMCL Domain Overview shows what an OMCL read write user from the OMCL AT_AGES B can do when opening his her own records Seite 15 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The OMCL Domain Records Structure Detailed Records of OMCLs Sub Navigation After clicking on Open the main detail screen of the OMCL AT_AGES B opens JMOL 167 MOL Code OMCL Name Country Code Town lin Address MOL Document Modkbed Dat Modited By Contact Comments OMCL Lab Cal Documents Prim Delete C Last Conlormity Date KIT o o OMOL AT AGES B MCL Internal Code AGES PharmMec Austrian Medicines Agency usta 0 MCL Net Member Fulmember M ema i y SASA Admin Structure DrectOMCL Contat M E MS Type ISO 17026 y 1160 Ven Possingergasse So 1160 Vien Possingergasse 3 0 Document stored 11062007 Modsed Tre 16480 ichard wanko Sedam eu reated By chard wanko edgm eu f r aa ord Previous Next Record Last Record Backtolist Save Navigation Rider Please have a look at the riders bar on top of this screen which allows you to switch between different sub sections folders They are defined as follows OMCL Mainscreen Provides general information about the OMCL Contact Provides information about OMCL and QA contacts Comments This page allows you to add free text related to different activities of your OMCL OMCL
41. rint List In order to create a new record please click on the button Add record which is located on the bottom end of the competence list You will reach a blank mainscreen which allows you to start entering a new record The following sub sites and screens explain the different table elements Seite 44 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The Competences Domain Mainscreen Basic Setting The blank main screen is the starting point for entering a new record Competence 0 56 c 0 oma OMCL AT_AGES B v Type v Ph Eur Chapter TestMetod Ka Sorting Group v Sub Method nn Obsolete No Competence Level Level 1 v Frequency Level Spot tes ng v OMS Covered C Last PTS Yea OS Comment Run ace Ph Eur a Mociied Date Modified Time OOO UD Modted By Created By OMCL Code The OMCL code of your OMCL will appear by default in the respective field in the upper right part of the folder It is not possible to change this code thus you are not able to add a competence on behalf of another OMCL Seite 45 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The Competences Domain Qualifiers Drop Down Test Method You can either keep the field Type empty In that case the pop up for Test Method will display the complete list of all registered test methods in alphabetic order from which you can select the method Please note This list is maintained by the EDQM administrators via the N
42. searches employing the combined search fields e g for BSP MSS Limitation of Combined Searches Please note There is no link between OMCL lab category and test method That means by choosing an OMCL and a lab category you will not end up in a list of all competences within a lab category of the selected OMCL This was done on purpose as otherwise the structure of the database would have become too complex and inflexible The Lab Category search in combination with a defined test method will instead result in a list of all OMCLs performing this test method which have in addition the respective lab category available within their organisation this search could make sense e g if you look for a biological orientated lab performing HPLC Print List You can print the short list of a search result in a standardised format by clicking on the button Print List which is located on the bottom end of the competence list Seite 33 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The Competences Domain Competence Overview If you clear all search fields and click on Search you come to the complete list of all competences sorted per OMCL OMCL Sn Test Mathai Sir Sub Method A Tye 2S Freq et Comp hi AD Fh Eur 59 OME ro AD Sper Ss In order to get detailed information about a competence record please click the button Open next to the respective record line Delete Competences lt is only possible to delete
43. stem will identify the username email address correctly On contrary the password is case sensitive So please respect capital and small letters in the password you have received via email In order to avoid typing errors it is recommended to simply copy and paste the password from your email to the password field RER pee richard Wwanko edgm eul Seite 6 von 65 Online Manual EDQM OMCL http www edqm eu omcldb How to Access the OMCL Database Changing the Password When logging in with the password that was provided to you by the automatic email a new dialogue box will open automatically with the request to change your password immediately In the first field Password you have now to enter the old password once again while in the next two fields New Password and Verification you enter twice a new password of you own choice You can select any password For security reasons it is recommended to choose a password with at least 6 characters Your password doesn t need to be a combination of letters and figures although this would make it saver in any case please don t forget that also your new password is case sensitive Before validating the new entries by activating the Change Password button you have to activate the tick box next to the Agreement declaration Please read first the Confidentiality rules for OMCL database before clicking the box Yes agree that follow
44. ten Medicines Agenc Subconfac tnd niormason Her ACTAENS No ce mments a Additional Information under Comment Folder The comments folder provides you with a variety of possibilities for adding information For any activities which you are subcontracting and for other activities e g research development you can use the respective fields to give additional information The text field notice should be reserved for quick information exchange e g the temporary shut down of a lab due to reconstruction works etc Finally the field comments is reserved for other general information related to your OMCL e g organisational items of general interest information about LIMS etc lf the text fields will be used frequently by OMCLs during the next couple of years to share information it might be envisaged to define some more standardised fields in the next version of the database In case you change data please don t forget to click on the Save button Seite 22 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The OMCL Domain OMCL Lab Cat Screenshot The OMCL Lab Cat main screen has the following structure OMCL Mainscreen Contact Comments Documents Pint Delete Last Conformity Dats 1701 72 M e MCL AT_ AGES OMCL internal Code AGES Pharm L Nam M La tint Lab Category OMS Last Assessment OMS Coverage Comment Arima housing human 1102 2006 Partaly Covered Biological and biotech human 07062004 Parta
45. the confidentiality rules By clicking on the Change Password button you have finally entered the database and can now work within the IT application An automatic email will be sent to your address confirming that your password has been changed successfully Seite 7 von 65 Online Manual EDQM OMCL http www edqm eu omcldb 6080 Receipt of confirmation of password change storm o _ et ame D E Mail s l schen Ist Werbung Antworten Analle Weiterleiten Drucken Von omcinet edqm eu Betreff Receipt of confirmation of password change Datum 11 Juni 2007 18 17 21 GMT 02 00 An Bj rn Senti Antwort an omcinet edqm eu Please be informed that your password to access the OMCL inventory database has been changed successfully Seite 8 von 65 Online Manual EDQM OMCL http www edqm eu omcldb How to Access the OMCL Database Errors while changing Password lf you have made a mistake e g use of wrong old password the two fields New Password and Verification do not match you have forgotten to activate the tick box the combination username and new password was already used earlier for this computer application etc you will receive an automatic message asking you to take corrective actions In case you wish to change your password at a later time point again you can do so whenever you enter the database by clicking on the respective button Change Password Password forgotten l
46. tp www edqm eu omcldb The OMCL Domain Search Functions Search Dialogue Box within OMCL domain OMCL Search OMCL Code not searched v OMCL name OMCL internal code Country not searched v EUEEA not searched v TownlArea OMCL Net Member not searched v Lab Category not searched v With the help of the search dialogue box you can narrow your search either by selecting from a pop up menu applicable for all fields which have an Arrow button on the right hand side or by entering a text in an empty field Please note Ihe searches in a free text field are wild card searches This means that you can search for the OMCL name Austrian Medicines Agency by entering Austr Med or Austr Ag but not by entering Ag Aust as the sequence of the words has to be adhered Search Field within OMCLs The search field OMCL name OMCL internal code covers the two fields OMCL Name and OMCL internal Code the search field Town Area covers the fields Area and Town It should be noted that entered text must not include text elements from both fields as the set up for searches does not combine texts from different fields but must only include elements from one of the two fields in order to get a positive result Activating a Search Button for OMCL Search Button In order to initiate a search the Search button has to be activated Clearing Search for OMCL You can delete all search options simply by c
47. trie SMOL AU TOAL Therapeutic Goods Administ akn Laborakwies durs trac COMCL BA_ MOS Inside for Medicines Quality Contr Bosnia Herzogovina OM CL BE _PH 6 Scene ee Rubee Heath Sac hon Baca Starter dan Et SM L BE_PH C Sen ee of Pubit Heath Meicnes Sector Beim OM CL GE VER Veterinary and amp grochem ical Research Canter Deigeum OM CL BG EDA Bulgarian Drug Agency Eager ik OMCL BG_ICVP OMEL CA BOTO Nador Weerinary Service rte ier Gori of Veterinary Maria Proc Bologios and Genetic Therames Direciorale Cara Buari Tow mim Ver Lanier Sarajevo Ernie Bryesets rel Sk Sia OMICL NetiMea be im Fill rire er Ful member Eu ol Lei Ful member Full menm baer Ful member Ful member Full member Ful member Seite 62 von 65 Online Manual EDQM OMCL http www edqm eu omcldb General features in the OMCL Competences User domain Saving Information Please note In case you switch between folders within the OMCL or Competences domain all data which have been added or changed in the folder you have just left will get lost if you forget to click on the Save button This is not applicable for information added modified or deleted with an Add record Edit record and Delete button JMOL 1967 Contact Comments OMCLLabCat Documents Print Delete ic EDS Last Conformity Dat 01200 OMCL Code OMCL ATLAGESS o MCL Internal Code AGES PharmMed OMCL Name Austrian Medi
48. turers and the programs MSS BSP CAP are selected from pop up menus Seite 51 von 65 Online Manual EDQM OMCL http www edqm eu omcldb 69 MA OMCL AT_AGES 6 Type Ph Eur Chapter TE Test Method enocmaltonily Sub Mood OT Seite 52 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The Competences Domain Deletion of an Attribute With the allocation of a specifier orogram there also appears a Delete button in the respective line which allows the authorised user to delete the attribute again if necessary Arama D Species Name 27 quneatig Delete 24 name Delete rn Tg Product Class D ProaguctClass peaseccecthacs Manufacturer D Manufacturer aoe ec ai z Modified Date 27112007 Modded Tine 10 14 10 Modited By Nchardwanko Sedam eu Created By Nchardwanko edam eu Fast Record Previou Hei a Next Record Last Record Back to List Save Seite 53 von 65 Online Manual EDQM OMCL http www edqm eu omcldb The Competences Domain Specifiers PTS OCABR PTS History OCABR Information The same principle also applies to the PTS history located under program with the only difference that data input is not handled via a pop up menu but manually The years of performance of a PTS are added to the record cumulatively lf methods are involved in OCABR activities a tick box has to be activated PTS Year COGADH L 2001 Next Record
49. y mistake all user records of an OMCL at least one OMCL administrator account always remains per OMCL m Leet You cant Ges your Own rector d Seite 60 von 65 Online Manual EDQM OMCL http www edqm eu omcldb General features in the OMCL Competences User domain The General functions are applicable for the three domains OMCL Competences and User An overview is given by the sitemap below Search Activating a Search Search Button In order to initiate a search the Search button has to be activated Clearing a Search Clear Button You can delete all search options simply by clicking the Clear button or by deleting them manually step by step OMCL Search OMCL Code notsearched Mi OMCL name OMCL internal code CRE Country not searched v EU EEA not searched v Town Area OMCL Net Member notsearched M Lab Category notsearched Fer Seite 61 von 65 Online Manual General features in the OMCL Competences User domain Sorting of Lists EDQM OMCL http www edqm eu omcldb The OMCL Competences and User lists can be selected in ascending or descending alphabetic order by clicking on the respective arrows next to the column titles In the upper left corner you get information about the number of records available within this domain COL ETET OGL Cone OMOL Name sie County m CMCL AT_AGESE Aula een Agency TEL OMCL AT_AGES C durs tien Mechcanes Agency durs
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