Waters Nordic 2011 User Training September 6th to 9th, · PDF fileWaters Nordic 2011 User...

©2011 Waters Corporation 1

Technology and Services for software and System qualification

Heather LongdenHenrik T. Christensen

Waters Nordic 2011 User TrainingSeptember 6th to 9th, 2011

©2009 Waters Corporation | COMPANY CONFIDENTIAL©2011 Waters Corporation

The Agenda:The Agenda:

Waters Nordic 2011 User TrainingSeptember 6th to 9th, 2011

Technology and Services for Software and System

Qualification

� Qualification and SQT. Waters and Agilentqualification capabilities.

� Advanced Verification Technology (AVT).� Managing system qualification data. � Q&A.


Wouldn’t be nice if…Wouldn’t be nice if…

� AQT – Advanced Qualification Technology

� SQT – Systems Qualification Technology

� AVT – Advanced Verification Technology

Click to VALIDATEClick to VALIDATE


ConnectionsAQT


ConnectionsAQTConnectionsAQT for Empower 3for Empower 3� 21 CFR Part 11 Compliant Ready

Records

� Automated Documentation

� On-line Qualification Documentation For Easy Inspection

� Easy Integration Into Laboratory SOPs


What is SystemsQT?What is SystemsQT?� Waters Empower SystemsQT is the next generation in

automated instrument qualification.

� It enhances the Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) testing and qualification data management of your UPLC & HPLC systems in an Empower / Empower 2 & Empower 3 software environment.

� SystemsQT Offers:— A whole system test approach for more accurate indication of

overall system-level compliance.— Secure, easy access and traceability of qualification data— Multiple systems can be qualified at the same time.


Systems Qualification TechnologySystems Qualification Technology


SystemsQTSystemsQT Key BenefitsKey Benefits� Simple wizard interface built into Empower 1,2 or 3 – launched from Run Samples.� The SystemsQT wizard displays the qualification tests based on the Empower project.� For system qualifications all tests are selected. To run specific tests simply deselect the tests you do not require.� Each system configuration has its own SystemsQT Empower project.� Simply restore the project, set-up the system, insert your samples, equilibrate and run - its that easy!� All the SystemsQT qualification documentation can be saved to a customer specific location for easy access, review and retrieval� All SystemsQT project calculations are automated.


SystemsQT Key BenefitsSystemsQT Key Benefits� SystemsQT reports can be signed off on-line or printed and signed off

manually

� Installation Qualification Reports are generated in Empower using the Acquisition Server / processing Node properties to enter IQ details.

� System Qualification Data storage within a database for complete data security, data traceability and data mining capabilities

� Full audit trail of user activity in the software


Is there a Minimum Service Pack or Is there a Minimum Service Pack or Feature Release?Feature Release?

� Yes— SystemsQT is integrated within Empower

o For Empower 1, Service Pack L or greater must be loaded

o For Empower 2, Feature Release 4 or greater must be loaded

� NO— SystemsQT is integrated within Empower

o For Empower 3, Base Software


SystemsQT Screen shotsSystemsQT Screen shots� Enable the option with the

SystemsQT License� Launch SystemsQT from Run

Samples-Qualify System

� Enter Service Password


SystemsQT WizardSystemsQT Wizard� Introduction � Test Selection


What Configurations are currently What Configurations are currently available today? available today? ––ACQUITY UPLCACQUITY UPLC

� ACQUITY UPLC� ACQUITY FLR� ACQUITY TQ� ACQUITY SQ� ACQUITY TUV� ACQUITY PDA/2996� ACQUITY ELS

Alliance 2695 /Alliance HT 2795�2489�2998�3100�2487/996/2996/2475*/

410/2410/2414*(*2695 only).

Modular HPLC

System of 1525/1525 micro pump2707 auto-sampler

With the following detectors�2489 UV-VIS�2998 PDA�2414 RI�2475 FLR


SystemsQTSystemsQT for Agilent 1100 / 1200 HPLC Systems for Agilent 1100 / 1200 HPLC Systems and and 6850 Series II GC, 6890N GC, 7890A GC6850 Series II GC, 6890N GC, 7890A GC

� Waters Compliance Services is offering the SystemsQT for

Agilent LC AND GC Systems

— As a one time qualification service — As a one time qualification service

with maintenance protocol (MP)— Service Plans with qualification option

and self directed also available.


Self Directed SystemsQT ProgramSelf Directed SystemsQT Program


Self Directed SystemsQT ProgramSelf Directed SystemsQT ProgramBenefitsBenefits� Reduced costs

— Using available metrology/ in-house resources

� Greater flexibility— immediately perform qualification following repairs or upgrades— Perform full or module testing as per SOP— Schedule qualification around regular in-house service maintenance

� Increased productivity— Perform multiple systems qualifications at the same time.— Your only limitation is the number of systems you can take offline

� Transparency and Standardization— SQT provides a specific protocol and test descriptions/specifications

documentation, in addition to the Empower Project which allows for viewing of all methods used for the system qualification.

— Allows for a Standard Protocol to be used for ACQUITY, Alliance, Agilent LC & GC systems


Advanced Verification Technology (AVT)


What is AVT?What is AVT?� AVT stands for Advanced Verification Technology

� Simulates keystrokes of a user executing detailed test instructions

� Developed under the Waters WWSDLC

� Application runs unattended

� Designed to incorporate modified or additional tests with less validation burden


What does AVT for Empower 3 Test?What does AVT for Empower 3 Test?� Administration & Security

— Demonstrates granularity of privileges and hierarchy within the application.

— Not ALL personnel should have admin rights— Challenges rules defined in the system policies around user

authentication and lock out

� Audit Trail— Answers the question, who, what, when, and where— System, Project, Method, Sample, Result


What does AVT Test What does AVT Test –– continued…continued…� Custom Calculations

— Creating and configuring custom fields / calculations viewable in a report.

� Electronic Signatures/Electronic Reports— Signing a record for final approval – 2 levels — Locking channels post approval

� Processing— Reprocessing of data yields same results as original data— Simulates a manual integration event

� System Suitability— Suitability for unknown peaks— Calculate and compare suitability results against defined limits


Demo


Log on Screen for AVTLog on Screen for AVT


Test Selection ScreenTest Selection Screen


Input FileInput File


Input File DetailsInput File Details


Execution ‘Start’ ScreenExecution ‘Start’ Screen


Summary ReportSummary Report


Summary Report Summary Report –– Test ParametersTest Parameters


Detailed ReportDetailed Report


Objective EvidenceObjective Evidence


Benefits of AVTBenefits of AVT� Removes validation barrier for adopting new technologies or upgrading software

� Reduces human error – less risk for deviations/discrepancies

� Execution time taken from 5 days to 8-12 hours in client/server environment

� Business benefit for customer— Less involvement— Ease of review


Supporting Documentation/Services for Supporting Documentation/Services for AVTAVT� Trained and certified Service Engineers for on-site AVT

execution

� Licensing and pricing will based on a per database instance or if desired, per client basis

� Traceability of testing

� Summary and detailed AVT reports

� Waters supplied projects for review


Validation Consulting ServicesValidation Consulting Services√Risk Assessment

√Validation Planning

√User Requirements Specification (URS)

√System Design Specification (SDS)

√Requirements Traceability Matrix (RTM)

√Validation Summary Report(s)

√Standard Operating Procedures (SOPs)


Services that support the Validation Services that support the Validation efforteffort

� On-site and remote support as necessary� Review and update of deliverables (documents and tests)� On-site execution of AQT and AVT� Assistance with manual test case execution (if required) and training around test objective and prerequisites� Project Management services for the implementation/validation effort


ManagingSystems Qualification Documentation Data

Managing Empower Qualification data with SDMS.


ConnectionsAQTConnectionsAQT Paper CountPaper Count� Installation Qualification Report:

— No of Pages: 34� Operational Qualification Reports

per project:— Valid_OQ1-33 pages— Valid_OQApex-33Pages— Valid_OQMVM-25pages� Total number of pages per Client

if Traditional, ApexTrack and MVM are qualified:— 125 pages


SystemsQTSystemsQT Paper CountPaper Count� Installation Qualification Report:

— No of Pages: 3 pages

� System Qualification Reports — Example ACQUITY PDA TQ:— 13 separate reports— 46 Pages


Is there a way to manage this and other qualification data?


Challenges in Managing Challenges in Managing Qualification DocumentationQualification Documentation� Qualification of software (IQ, OQ)� Regular (re-) qualification of instruments� Documentation-intensive process� Generates large amounts of paper reports

— Storage issues— Search/Retrieval issues

� Audits— Availability/Retrieval issues


The Importance of Retaining ALL The Importance of Retaining ALL Qualification DataQualification Data� Yunnan Hande Bio-Tech. Co. Ltd.�

“Your firm also fails to maintain raw data associated with the re-qualification and calibration of your laboratory instruments. During the inspection the investigators were informed that the annual re-qualification and calibration of your laboratory equipment (e.g., HPLC, GC, polarimeter, and analytical balance) is performed by the (b)(4). However, you were unable to provide raw data or documentation regarding the qualification and calibration of your instruments and data to demonstrate that your quality unit reviewed and approved the work performed by your contractor.”


Analytical Data ManagementAnalytical Data Management

QUALIFICATIONSAMPLES

SQT TESTS QUALIFICATIONREPORTS

SQT PROJECTS QUALIFICATIONRESULTS


What will SDMS do?What will SDMS do?� Capture Raw Data in SDMS

— Empower Projects— Files from file based laboratory applications

� Capture Printed Reports to SDMS— Manually — Automatically— Event based after signing

� Automatic indexing via templates

� Use SDMS ELN — To produce Summary Reports— To document manual qualification procedures


Report in Empower 2Report in Empower 2


Report CaptureReport Capture


Catalogue AutomaticallyCatalogue Automatically


Find and Review Through a Web Find and Review Through a Web BrowserBrowser


IQ ReportIQ Report


OQ ReportOQ Report


Other Qualification Other Qualification DataData

� Capture all of your qualification documentation in SDMS� Review and approve over the web

3rd Party LC

Balances

NMR Plate Readers

FTIR UV


Creating Qualification SummariesCreating Qualification Summaries


Reports in FormReports in Form

Hyperlinks to printed reports in SDMS


Other DevicesOther Devices

My pH meter doesn‘t come with qualification tools. I use an SOP to

qualify it.


Vision PublisherVision PublisherTemplate with predefined workflowTemplate with predefined workflow


Centralizing All Instrument Qualification Centralizing All Instrument Qualification Records in NuGenesis SDMSRecords in NuGenesis SDMS� Benefits

— All system qualification reports centrally managed in a single electronic repository

— Web-based solution for electronic review, approval, and regulatory inspections

— Report traceability back to archived projects for easy retrieval— Reduces document warehousing costs and eliminates waste and

non-value added steps in the process


QuestionsQuestions

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