Welcome to our E-Seminar: Automation Tools for Efficient Result Review According to GMP

Transcription

1 Welcome to our E-Seminar: Automation Tools for Efficient Result Review According to GMP

2 Overview Overview Chapter Page Overview The sample lifecycle 6 Chromatographic data system and the sample life cycle 7 Introduction From sample to result 8-9 Requirements for good quality results 10 Review steps How to acquire good quality final results Productivity enhancements 14 Impact Automation Network monitoring and level Custom calculation and limit checks Result review and approval Compliance Summary 30

3 Overview The sample lifecycle f o r QC Sample Analysis Results Certificate of Analysis Historical Data Quality Data opt. custom calculations Login Naming Attribute entry Analysis scheduling Result Generation Work acceptance Analysis results Review Sample Related results Approval Sample Archive Copy for backup Delete Remove sample from database LIMS ID SAP - QM Reopen Reopen a sample for additional tests De-archive Move samples back to database

4 Overview Overview: Where will a CDS interfere CDS ( Chromatographic Data System) will focus on analyzes, and result creation, final result calculation and batch release CDS must be integrated in higher level corporate Data Handling solutions such as LIMS, ERP and data archiving systems A fully flavored CDS covers ~80% of the tasks from sample logging to final result release Significant productivity benefits can be reached if the user s routine tasks are integrated into the CDS

5 Introduction Introduction: Routine Tasks from sample to result 17% From sample to result 6% 22% 1 Sample preparation 2 Analyzing sample 3 Calculate final results CDS can cover steps 2-5 plus parts of 1 and 6 11% 17% 4 documentation 27% 5 Review and release 6 Archive

6 Introduction Introduction: Tasks from sample to result Sample preparation: Logging, assigning procedure, analytical preparation ( extraction dissolution/dilution/derivatization), scheduling Sample analyzes: Evaluate system suitability, prepare standards, setup batch, run batch, review analytical results ( e.g. integration,purity, identification) Calculate final results: calculate compound results, apply advanced calculations, compare with given limits, create final report Review and release: present final results to first-pass and peer reviewer, sign-off, release Archive: Copy/move data to external storage devices, provide and monitor archive catalogue

7 Introduction Requirements for Compliant results Evaluate system suitability before analysis Have and follow SOP for analysis Analyze sample and document all acquisition data Ensure error-free execution of analytical data acquisition Calculate final results Evaluate results and sign-off Document all steps from analysis to result

8 Review steps Steps to acquire analytical raw data Analyzes Equilibrate system Have Have good good quality quality analytical analytical raw raw data data Manually review equilibration status Run system suitability samples Manually check for sys. Suit pass/fail If pass sys suit run sample batch Manually evaluate hardware performance (QC samples, maintenance )

9 Review steps Steps to acquire final analytical results Results Review chromatogram Manually review integration settings Review data analysis results Manually check compound identification Confirm identification results Manually confirm compounds with a reference Complete Complete sample-based sample-based review review Transfer results to calculation module Execute cross sample calculations Manually compare with limits and map to analytical results Get Get good good quality quality final final results results

10 Review steps Final review Results Review and Release Analyst: Review final reports (Manually) sign reports Peer Review final reports (Manually) add second signature Release batch Document release Final Final sign-off sign-off of of sequence sequence Lock Lock data data and and move move to to archive archive

11 Impact Productivity Enhancements Key to enhancing productivity is automation of manual steps Integrate ALL steps from analysis to final sign-off in one application Eliminate as much manual review steps as possible through automation Have system-generated documentation on all steps Ensure unattended operation can be monitored with system tools These requirements do have a significant impact on the system architecture!

12 Impact Overview modular software architecture Using modular software architecture and standards based technology is the basics for an integrated data system COM/DCOM based architecture allows for easy integration of powerful tools for special applications Example: Custom Calculation module integrated into Cerity Modular design offers combination of focussed modules to a powerful overall solution Communication based on TCP-IP allows ongoing system monitoring during unattended operation

13 Break Number 1

14 Impact Automation of result creation Automated creation of Good quality data is the key to fast and efficient result review Automate acquisition of good quality analytical raw data through Usage of network technology for ongoing system monitoring during acquisition Benefit from level 4 instrument control for secure unattended instrument operation Automate good quality final results creation through Combination of spreadsheet calculations for system suit and result limits with a clear result representation Automation compound identification based on RT and UV-Spectrum Clear graphical coded result representation Use embedded calculation tools for final result calculation (e.g. content uniformity or total amount of unknowns) eliminating the need for result export/re-import Apply electronic signatures to all sign-off steps like in your lab notebook

15 Automation Data Acquisition: Automated Instrument Failure Notification Office HPLC HPLC Laboratory GC Agilent Advisor Notified LAN Computer room Mail Server File Server Application Server Data Base Hub WAN

16 Automation Data acquisition: Benefit from level4 instrument control Configure maintenance limits for the system Integrate EMF information with each run EMF violations documented in instrument logbook Documentation of all acquisition events in the logbook

17 Automation Data acquisition: Benefit from level4 instrument control Documentation of all instrument events in the logbook Online/offline information Communication errors Instrument changes System information such as bottles are empty

18 Automation Result creation: Custom calculator Extra power through built-in spreadsheet calculations Part 11 compliance Full versioning of all calculation results and modifications Properties tab for existing columns: header and display can be modified without deleting the column Insert columns into an existing spreadsheet and keep all formulae Combine the calculation power of a true spreadsheet with the compliance power of Agilent Cerity

19 Automation Result creation: Limit checks Automation off limit checks according to your SOP with spreadsheet-based calculation tool benefit: Final results are available immediately after acquisition and Result notifications can be reported in eye-catching format (free configurable) SOP says: RSD of multiple injections for comp XYZ must be below 1% Applied to all samples with a given marker or to a predefined subset Applied to individual compounds, a group of compounds or all compounds Automated notification Automated user actions

20 Automation Result creation: Spectral compound confirmation Automated manual compound confirmation during initial result calculation Compound confirmation integrated into method-based peak identification Takes full benefit of DAD Speeds up result review Confirmation is optional Prevents manual errors and undocumented modifications Identifies peak based on RT AND confirms peak based on UV spectrum Peaks not confirmed will not be quantified

21 Automation Result creation: Final result for review Cerity delivers results in a user friendly format ready for immediate decision Graphical representation of results Color coding for quick visual result inspection Review of overlaid and residual spectra No interactive modification

22 Automation Result review Use your data system as electronic lab notebook: Configure e-sig to all review tasks as you do it in manual form Provide a reason as requested Sign-off analytical final results with a maximum of 3 levels Lock results after final approval Configure LIMS upload or archive depending on sign-off

23 Automation Automated Result review Key steps for fast and efficient result review: Automation of manual steps Check for equilibration and sys. Suit Automated limit checks pass/fail Manual monitoring of system performance Automated system monitoring with level 4 instrument control incl. EMF and network system monitoring Review of integration Remains manual Review of identification and compound Automated compound purity and confirmation confirmation Manual result transfer to calculations Not required, automated spreadsheet module calculations available in the data system Manual Execution of calculations with Automated calculations and limit manual limit checks checks Manual result check for pass/fail Automated clearly colour coded pass/fail display Manual sign off after review Integrated 3 level sign off compliant with part 11 Key tools: Network and system monitoring systems Upfront maintenance and powerful diagnostics tools Built-in spreadsheet calculation tools combined with advanced automation engine and limits configuration tool UV spectra evaluation tools for identification and confirmation MS standard tools for system administration Integrated database archiving routines with full audit-trail

24 compliance Audit-trail documentation Any tool is only as good as its documentation! Sign-off audit-trail Calculation audit-trail

25 compliance Audit-trail documentation Any tool is only as good as its documentation! Instrument logbook = Acquisition audit-trail Results audit-trail including discarded changes

26 compliance Long-term data Management Data archiving is required for compliance and for data management reasons Data archiving must be an integral part of the application including Locking and restore routine Full audit-trail documentation of all activities Tools for conflict resolution in case of duplicated records Allowing for linking sign-off, archive and result transfer e.g. To LIMS/ERP

27 Summary Summary Using a set of advanced tools in Agilent Cerity combined with inclusion of latest technology into system design offers the quickest path from measurement to result with the following benefits Get final good quality results two times faster than anybody else Support for a paperless laboratory Less validation costs and highest security because of integration of latest IT technology Most reliable and cost-effective system: 1100 hardware and Cerity architecture reduce operation costs because they are designed for unattended 24 7/7 days operations