SWIFT SILLIKER - LABWARE LIMS AND ISO ACCREDITATION Paul Roberts

Transcription

1 SWIFT SILLIKER - LABWARE LIMS AND ISO ACCREDITATION Paul Roberts

2 Contents About Swift Silliker a Mérieux NutriSciences Company. LabWare LIMS compliance with SANAS & ISO requirements. Location capability & accreditation. User Roles & Functional Privileges. Clause 4.13 Control of records. Clause Technical records Audit Trail Instrument Manager Clause Control of data Data transmission: electronic sending of COAs. Clause 5.10 COA Manager 2

3 A public health player As part of Institut Mérieux, Mérieux NutriSciences is dedicated to advancing global public health: by delivering a wide range of services to the food and nutrition value chain 3

4 A deeply rooted history Mérieux NutriSciences benefits from The solid scientific legitimacy of Institut Mérieux An independent, family owned group with a Pasteurian tradition since 1897, the company commits its experience in industrial biology to serve medicine and public health Strong food safety expertise Silliker s 45 years of experience in food safety and know-how in the agri-food industry 4

5 An Institut Mérieux company Over 12,000 people committed to global public health Industrial sites and laboratories in 40 countries Sales of over 1.8 billion euros 5

6 Mérieux NutriSciences Our vision «Advancing food sciences, improving health» Mission Providing services and solutions on a global basis, from food safety and environmental monitoring to research in nutrition OUR VALUES Integrity Excellence Accountability Initiative 6

7 Mérieux NutriSciences Mérieux NutriSciences provides laboratory, auditing, consulting, contract research and education services to 6 strategic industries Mérieux NutriSciences offers research services for innovation in nutrition through the Biofortis business unit BIOFORTIS 7

8 The strength of an international network Provides laboratory, auditing, consulting, contract research and education services Strong food safety experience Offers Research services for innovation in nutrition 8

9 Labware LIMS Landscape Silliker Global has a historical working relationship with LabWare Silliker Laboratories globally utilize LabWare LIMS since Started off with version 3. Globally - 5 LabWare LIMS installation (3 v5 & 2 v6) 24/7 365 Days Worldwide Laboratory Operations High throughput environment ~ 25K samples / day ~ 70K tests / day ~ 8K COA s / day 9

10 Mérieux NutriSciences: Growing presence in emerging countries First presence in the South African market First commercial food testing laboratory with an ISO accreditation in South Africa. Largest food testing laboratory in Southern Africa. State-of-the art chemistry laboratory opened in October Largest portfolio of accredited microbiology tests and training courses. Accredited laboratories in Johannesburg and Cape Town. 10

11 Swift Silliker s footprint in Africa Presence in Africa Currently servicing 64 Clients in 27 Countries throughout Africa. 27 Global Key Accounts in Africa. 11

12 LabWare LIMS and compliance with SANAS ISO requirements LabWare LIMS V6 being a commercial off-the-shelf software in general use with the designed application range is considered sufficiently validated. Standard LIMS functionalities have been utilized and where configurations/modifications have been made these have been sufficiently validated. LabWare LIMS has been configured to meet SANAS ISO requirements for both Swift Silliker Testing Laboratories T0050 and T0350. LIMS configurations: User Roles, Functional Privileges and Group Names. Analysis capability and accreditation. Auditing (Audit Trails). Instrument Manager. COA Manager. 12

13 LOCATION CAPABILITY & ACCREDITATION Table Manager Table Manager s Location: Set Group Name, Outside = False, insert Certificate of Accreditation 13

14 LOCATION CAPABILITY & ACCREDITATION Table Manager Location: Select Accreditation 14

15 LOCATION CAPABILITY & ACCREDITATION Table Manager Location s accreditation: Add Analysis 15

16 LOCATION CAPABILITY & ACCREDITATION Table Manager Location s accreditation: Select Add and prompter pop up appears 16

17 LOCATION CAPABILITY & ACCREDITATION Table Manager Location s accreditation: Browse and select the Analysis Code, Component select * if all components are Accredited, Accredited = True. 17

18 LOCATION CAPABILITY & ACCREDITATION - Visual Workflow Using Visual Workflow Location Capability and accreditation: Configure the Role Quality Manager with Functional Privileges 18

19 LOCATION CAPABILITY & ACCREDITATION Visual Workflow VW Maintain Accreditation status for a Location : 19

20 LOCATION CAPABILITY & ACCREDITATION. Locations opens, select Open Entry 20

21 LOCATION CAPABILITY & ACCREDITATION. Locations opens, select Open Entry << LIMS Browser>> browse for the Location 21

22 LOCATION CAPABILITY & ACCREDITATION. The selected Location s Analysis Accreditation status can be maintained from here by the Quality Manager. 22

23 AUDIT TRAILS - Rules and Events Manager Full Audit Trail and Changes Manager in compliance with Clause 4.13 Technical Records Set using Configure > Rules and Events Manager 23

24 AUDIT TRAILS Rules and Events Manager Rules and Events Manager is configured in accordance to comply with ISO such > Business Rules > Auditing. 24

25 AUDIT TRAILS Rules and Events Manager Full traceability on changes > Select History to view the Business Rules History 25

26 AUDIT TRAILS Rules and Events Manager Logon is utilized as part of compliance to Clause Control of data b) procedures are established and implemented for protecting the data > LIMS User access and security. 26

27 AUDIT TRAILS Changes Manager Changes Manager: Menu item > Utilities > Changes Manager. 27

28 AUDIT TRAILS Changes Manager Changes Manager: select the Date Range and Query. 28

29 AUDIT TRAILS Changes Manager Changes Manager: Query Result of changes made. Table Name, Record Name, Record Version, Changed On, Changed By, Group name, and Removed = T or F. 29

30 AUDIT TRAILS Project Audit History Projects Manager has the menu item Audit > Audit History. Project Audit History gives a full view of the Project s Audit Events full history giving full traceability. 30

31 AUDIT TRAILS Project Audit History Selecting the Audit History opens the window to view all timestamped events with the functionality to view and drill down. 31

32 AUDIT TRAILS Project Audit History Click on Audit Type UpdateProject this then displays the Action, Table and Entry. Click on the Action Entry then Item Details. 32

33 AUDIT TRAILS Project Audit History The Table History Dialog displays with the Event Type details, LIMS User, Audit Timestamp and all related data details relating to the event. 33

34 AUDIT TRAILS Project Sample Audit History Project Samples select the menu item Audit > Audit History. 34

35 AUDIT TRAILS Project Sample Audit History Sample Audit History window view, displaying Sample s Audit History. All Audit Types Time Stamp, Operator (LIMS User), Reason and Signed gives full traceability. 35

36 AUDIT TRAILS Project Sample Audit History Select an Audit Type then select the View button, this opens the Sample Drill Down window. Note that the Sample and Test displays as it would to the LIMS User at that time stamped moment. 36

37 AUDIT TRAILS Project Sample Audit History Sample Drill Down, drill down on the Test then select the Component. The right hand window displays the data. In this case Numeric entry, Status = Authorized, Data Entered By, Reportable, Reviewer and the time stamp. 37

38 AUDIT TRAILS Project Sample Audit History Sample Drill Down, select the History button and the full Audit Event details display for the specific component. For Project, Sample, Test and Test Component LIMS has full traceability. 38

39 INSTRUMENT MANAGER Instrument Manager is utilized as part of compliance to Clause Technical records The laboratory shall retain records of., calibration records, Clause 5.5. Equipment Up-to-date instructions on the use and maintenance of equipment (including any manuals provided by the manufacturer of the equipment) shall be readily available for use Records shall be maintained of each item of equipment or otherwise identified to indicate the status of calibration, including the date when last calibrated and the date or expiration criteria when recalibration is due. 39

40 INSTRUMENT MANAGER Table Manager Entry Table Instrument > Add Instrument Entry details, Calibration/PM interval, Ext Link (Manual), Group name, serial number 40

41 INSTRUMENT MANAGER Visual Workflow From Main VW select Instrument Manager 41

42 INSTRUMENT MANAGER Visual Workflow VW Instrument Manager: Manage Instruments, as well as, Calibration and PM Expiration Date Reports available. 42

43 INSTRUMENT MANAGER Selecting an instrument Select open instrument 43

44 INSTRUMENT MANAGER Selecting an instrument Select open instrument > select Instrument Group or Instrument by Instrument Name. 44

45 INSTRUMENT MANAGER Selecting an instrument Select Instrument Group Balances > State (In Service or Out of Service), Instrument Manual, Calibration, PM, Service history and document records managed (Clause Technical records) 45

46 INSTRUMENT MANAGER Instrument s LIMS entry records time-stamped with full audit history. 46

47 INSTRUMENT MANAGER The instrument s history is available including Calibration Records & Certificates, Preventative Maintenance and Service Records & Documentation. 47

48 COA Manager Clause 5.10 Reporting the results ISO Clause 5.10 Reporting the results is fully complied with using LabWare s COA Manager functionality Clause Test reports a) a title. b) the name and address of the laboratory; c) unique identification of the test report; d) the name and address of the customer; e) identification of the method used; f) a description of, the condition of, and unambiguous identification of the items tested; g) the date of receipt of the test item(s) ; i) the rest results with, where appropriate, the units of measurement; j) the name, function and signature or equivalent of person authorizing the test report; k) where relevant, a statement to the effect that the results relate only to the items tested. 48

49 COA Manager Clause 5.10 Reporting the results Test reports - Title: MICRO FINAL COA, Customer Address, Report Number, Test Item s unique Sample Number, Test Date, Test Item Description 49

50 COA Manager Clause 5.10 Reporting the results Test reports - Test, Method Number, Test Result, Reporting Units, Name, Function and Signature of person authorizing the test report. 50

51 COA Manager Clause 5.10 Reporting the results Clause Amendments to test reports Material amendments to a test report after issue shall only be made in the form of a further document, which includes the statement: Supplement to test Report, serial number,,,[or otherwise identified], or an equivalent form of wording. 51

52 Electronic transmission of results ISO Clause Electronic submission of results Clause Control of data b) data storage, data transmission and data processing; LIMS is utilized to electronically transmit results, namely the Certificate of Analysis, to the Customer s Report Recipients. To utilize this functionality configuration is required in the LIMS Constants, Background Scheduler, SMPT Server, Subroutines, Address Book, COA Distribution Lists. Project Manager In the Project an Distribution List can be either manually added to the Project or when configuring the Distribution List select for All Projects = True for the specified Customer. 52

53 Electronic transmission of results Project Manager Project Manager Items > Report/Invoice Recipients tab contains one Report Recipient. 53

54 Electronic transmission of results Project Manager Project Manager Adding a Distribution List on the fly. Project Manager menu item select Reporting > Add Distribution List. 54

55 Electronic transmission of results Project Manager Search Dialog window opens. 55

56 Electronic transmission of results Project Manager Enter the search criteria, example Customer: Swift > select Search. From the result, select the desired Distribution List > select OK. 56

57 Electronic transmission of results Project Manager Information popup displays stating Distribution list added successfully. 57

58 Electronic transmission of results Project Manager Project Manager Items > Report/Invoice Recipients tab now contains an additional two Report Recipient. To now distribute the COA select the menu item Reporting > Distribute COA to all Recipients. 58

59 Electronic transmission of results Project Manager Select the Report Number for which to Distribute the COA. 59

60 Electronic transmission of results Project Manager To view the record of the COA distribution select Reporting > Sow Project Communication. 60

61 Electronic transmission of results Project Manager Contact Manager opens, displaying the full Project s Contact Type, time stamped with Notified By (LIMS User). Full traceability with regards to the electronic transmission of results. 61

62 Alert Manager and compliance to Clause 4 Management requirements ISO Clause 4 Management requirements: k) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the objectives of the management system Top management shall ensure that appropriate communication processes are established within the laboratory and that communication takes place regarding the effectiveness of the management system. Utilization of LIMS Alert Manager allows for the effectiveness of communications through laboratory management; communication is recorded electronically, time stamped, and traceable. 62

63 Alert Manager and compliance to Clause 4 Management requirements Alert Manager 63

64 Alert Manager and compliance to Clause 4 Management requirements Alert Manager: Creating an Alert, select the LIMS User(s) 64

65 Alert Manager and compliance to Clause 4 Management requirements Alert Manager: Enter message test, Response Required, Read Receipt, Acknowledgement Receipt, then select OK. 65

66 Questions 66