SWIFT SILLIKER - LABWARE LIMS AND ISO 17025 ACCREDITATION

Transcription

SWIFT SILLIKER - LABWARE LIMS AND ISO 17025
ACCREDITATION
Paul Roberts
Contents
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About Swift Silliker a Mérieux NutriSciences Company.
LabWare LIMS compliance with SANAS & ISO 17025 requirements.
Location capability & accreditation.
User Roles & Functional Privileges.
Clause 4.13 Control of records.
 Clause 4.13.2 Technical records
 Audit Trail
 Instrument Manager
Clause 5.4.7 Control of data
 Data transmission: electronic sending of COAs.
Clause 5.10
 COA Manager
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A public health player
As part of Institut Mérieux,
Mérieux NutriSciences is dedicated to advancing global public
health:
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by delivering a wide range of services to the
food and nutrition value chain
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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
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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
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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
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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
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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
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Labware LIMS Landscape
Silliker Global has a historical working relationship with LabWare
 Silliker Laboratories globally utilize LabWare LIMS since 1996.
 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
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Mérieux NutriSciences: Growing presence in
emerging countries
First presence in the South African market
 First commercial food testing laboratory
with an ISO 17025 accreditation in South Africa.
 Largest food testing laboratory in Southern Africa.
 State-of-the art chemistry laboratory opened in October 2013.
 Largest portfolio of accredited microbiology tests and training courses.
 Accredited laboratories in Johannesburg and Cape Town.
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Swift Silliker’s footprint in Africa
Presence in Africa
 Currently servicing 64 Clients in
27 Countries throughout Africa.
 27 Global Key Accounts in
Africa.
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LabWare LIMS and compliance with SANAS
ISO 17025 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 17025
requirements for both Swift Silliker Testing Laboratories T0050 and T0350.
LIMS configurations:
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User Roles, Functional Privileges and Group Names.
Analysis capability and accreditation.
Auditing (Audit Trails).
Instrument Manager.
COA Manager.
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LOCATION CAPABILITY &
ACCREDITATION – Table Manager
Table Manager’s Location: Set Group Name, Outside = False, insert
Certificate of Accreditation
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Location: Select Accreditation
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Location’s accreditation: Add Analysis
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Location’s accreditation: Select Add and prompter pop up appears
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Location’s accreditation: Browse and select the Analysis Code, Component
select * if all components are Accredited, Accredited = True.
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ACCREDITATION - Visual Workflow
Using Visual Workflow “Location Capability and accreditation:
Configure the Role Quality Manager with Functional Privileges
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ACCREDITATION – Visual Workflow
VW “Maintain Accreditation status for a Location”:
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ACCREDITATION.
Locations opens, select “Open Entry”
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ACCREDITATION.
Locations opens, select “Open Entry” << LIMS Browser>> browse for the
Location
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ACCREDITATION.
The selected Location’s Analysis Accreditation status can be maintained
from here by the Quality Manager.
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AUDIT TRAILS - – Rules and Events
Manager
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Full Audit Trail and Changes Manager in compliance with Clause 4.13
Technical Records
Set using Configure > Rules and Events Manager…
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AUDIT TRAILS – Rules and Events
Manager
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Rules and Events Manager is configured in accordance to comply with
ISO 17025 such > Business Rules > Auditing.
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Manager
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Full traceability on changes > Select History to view the Business Rules
History
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Manager
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“Logon” is utilized as part of compliance to Clause 5.4.7 Control of data b)
procedures are established and implemented for protecting the data >
LIMS User access and security.
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AUDIT TRAILS – Changes Manager
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Changes Manager: Menu item > Utilities > Changes Manager.
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Changes Manager: select the Date Range and Query.
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Changes Manager: Query Result of changes made. Table Name, Record
Name, Record Version, Changed On, Changed By, Group name, and
Removed = T or F.
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AUDIT TRAILS – Project Audit History
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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.
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Selecting the Audit History opens the window to view all timestamped
events with the functionality to view and drill down.
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Click on Audit Type “UpdateProject” this then displays the Action, Table
and Entry.
Click on the Action Entry then Item Details.
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The Table History Dialog displays with the Event Type details, LIMS User,
Audit Timestamp and all related data details relating to the event.
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AUDIT TRAILS – Project Sample Audit
History
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Project Samples select the menu item Audit > Audit History.
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History
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Sample Audit History window view, displaying Sample’s Audit History. All
Audit Types Time Stamp, Operator (LIMS User), Reason and Signed gives
full traceability.
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History
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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.
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History
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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.
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History
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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.
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INSTRUMENT MANAGER
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Instrument Manager is utilized as part of compliance to Clause 4.13.2
Technical records 4.13.2.1 “The laboratory shall retain records of ….,
calibration records,”
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Clause 5.5. Equipment
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5.5.3 “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….”
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5.5.5 “Records shall be maintained of each item of equipment”.
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5.5.8 “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.”
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INSTRUMENT MANAGER – Table Manager
Entry
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Table Instrument > Add Instrument Entry details, Calibration/PM interval,
Ext Link (Manual), Group name, serial number…
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INSTRUMENT MANAGER – Visual
Workflow
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From Main VW select Instrument Manager
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INSTRUMENT MANAGER – Visual
Workflow
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VW Instrument Manager: Manage Instruments, as well as, Calibration and
PM Expiration Date Reports available.
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INSTRUMENT MANAGER – Selecting an
instrument
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Select open instrument
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instrument
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Select open instrument > select Instrument Group or Instrument by
Instrument Name.
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instrument
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Select Instrument Group Balances > State (In Service or Out of Service),
Instrument Manual, Calibration, PM, Service history and document records
managed (Clause 4.13.2 Technical records)
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INSTRUMENT MANAGER
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Instrument’s LIMS entry records time-stamped with full audit history.
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INSTRUMENT MANAGER
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The instrument’s history is available including Calibration Records &
Certificates, Preventative Maintenance and Service Records &
Documentation.
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COA Manager – Clause 5.10 Reporting the
results
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ISO 17025 Clause 5.10 Reporting the results is fully complied with using
LabWare’s COA Manager functionality
Clause 5.10.2 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.
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results
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Test reports - Title: MICRO FINAL COA, Customer Address, Report
Number, Test Item’s unique Sample Number, Test Date, Test Item
Description
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results
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Test reports - Test, Method Number, Test Result, Reporting Units, Name,
Function and Signature of person authorizing the test report.
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results
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Clause 5.10.9 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.
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Electronic transmission of results
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ISO 17025 Clause 5.10.7 Electronic submission of results
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Clause 5.4.7 Control of data
5.4.7.2 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 e-mail 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.
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Electronic transmission of results – Project
Manager
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Project Manager – Items > Report/Invoice Recipients tab contains one
Report Recipient.
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Manager
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Project Manager – Adding a Distribution List on the fly.
Project Manager menu item select Reporting > Add Distribution List.
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Manager
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Search Dialog window opens.
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Manager
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Enter the search criteria, example Customer: Swift > select Search.
From the result, select the desired Distribution List > select OK.
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Manager
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Information popup displays stating “Distribution list added successfully.
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Manager
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Project Manager – Items > Report/Invoice Recipients tab now contains an
additional two Report Recipient.
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To now distribute the COA select the menu item Reporting > Distribute
COA to all Recipients.
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Manager
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Select the Report Number for which to Distribute the COA.
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Manager
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To view the record of the COA distribution select Reporting > Sow Project
Communication.
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Manager
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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.
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Alert Manager and compliance to Clause 4
Management requirements
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ISO 17025 Clause 4 Management requirements:
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4.1.5 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.
4.1.6 “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.
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Alert Manager
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Alert Manager: Creating an Alert, select the LIMS User(s)
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Alert Manager: Enter message test, Response Required, Read Receipt,
Acknowledgement Receipt, then select OK.
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Questions
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SWIFT SILLIKER - LABWARE LIMS AND ISO 17025 ACCREDITATION

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