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Chromatography Data System: Comply with Regulations

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Overview about chromatography tools available to comply with regulations (IQ/OQ, User Management, Audit Trails and Versioning).

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Chromatography Data System: Comply with Regulations

  1. 1. 2 The world leader in serving science Streamline Your Laboratory Chromeleon CDS Seminar [Enter location and date here] Comply With Regulations
  2. 2. 3 Introduction • Software needs to meet regulatory requirements • Software must be 21 CFR Part 11 compliant for electronic signatures: • Controlling system access • Tracking system activities • Managing system data • Verifying correct performance • No loss in productivity • Avoid time consuming manual qualification procedures • Re-qualification costs must be kept to minimum
  3. 3. 4 Introduction • Compliance can be considered in four categories: • Security - this encompasses system access control and data security • Audit Trails - all actions and events within the CDS should be fully traceable • Record Management - all data should be stored, controlled and archived accordingly • Qualification - all aspects of the CDS installation need to be qualified to prove it is installed and working as expected
  4. 4. 5 Compliance – Security
  5. 5. 6 Security - User Management • Create Users, Roles and Access Groups
  6. 6. 7 User Management Roles • A role is a collection of privileges • Defines what a user can and cannot do • A user can be assigned different roles • At logon a user can choose an assigned role
  7. 7. 8 Controlled Access in Console • Access and roles can be controlled at every level
  8. 8. 9 Controlled Access in Console Full Data Structure Only R&D Folders Just QC Folders in Location 1
  9. 9. 10 Control of Access to Instruments
  10. 10. 11 Compliance – Audit Trails
  11. 11. 12 Audit Trails provided by Chromeleon CDS • Security logs • Instrument activity event logs • Modification history (object audit trails)
  12. 12. 13 Security Log • User management
  13. 13. 14 Instrument Daily Event Log
  14. 14. 15 Instrument Daily Event Log for each Sample
  15. 15. 16 • Displays complete change history of each object Modification History All Audit Trails can be searched, grouped and filtered Restore to Previous Version
  16. 16. 17 Modification History – Version Comparison Changes in objects are easily identified Change AdditionDeletion
  17. 17. 18 Compliance – Record Management
  18. 18. 19 Record Management with Chromeleon CDS • Flexible data organization options • Integrated electronic signature functions • Automatic scheduler tool for archiving • Exporting in FDA-approved formats
  19. 19. 20 Record Management – Electronic Signatures • 3 Levels of signature Submit, Review, Approve • Applied to electronic report • Complete sequence protected by checksums • Controlled by privileges
  20. 20. 21 Record Management – Electronic Signatures
  21. 21. 22 Compliance – Qualification
  22. 22. 23 Qualification Tools included with Chromeleon CDS • Provides a complete set of qualification procedures (AutoQ™) • Certificate of Validation • Automated Software IQ and OQ • Automated Instrument IQ and OQ • Automated System Suitability Testing
  23. 23. 24 Qualification • Qualification processes are fully automated (with occasional, minor manual interaction for instrument IQ/OQ e.g. pump priming) • Therefore qualification can be performed in as short a time as possible • All processes are available as standard, therefore requalification can be performed by the customer. This ensures down time and cost is kept to a minimum.
  24. 24. 25 Qualification – Certificate of Validation
  25. 25. 26 Qualification – Station IQ • Fully automated • Takes <2 mins • HTML based Qualification Report • Modern layout • Overview: • Expanding/collapsing details • Summary on the top 26 Modern looking, HTML based Details expanded Details collapsed Summary
  26. 26. 27 Qualification – Station OQ • Fully automated • Takes <7 mins • Comprehensive • Checks software operation • Includes Report Designer Pro functionality check • Complete Qualification Report • Stored in Data Vault (user defined location)
  27. 27. 28 Qualification – Instrument OQ • IQ: Checks communication between the CDS and selected instruments to verify instrument is correctly installed • OQ: Checks performance of selected instrument to verify correct operation • Runs series of sequences depending on installed modules and options
  28. 28. 29 Qualification – System Suitability Test (SST) • Built-in SST functionality – no license required • Setup versatile SSTs to ensure chromatography quality • Fully customizable • Templates for the most common tests • Evaluate SST Results offline, or as your samples are analyzed
  29. 29. 30 Summary
  30. 30. 31 Summary – The Chromeleon CDS Solution Thermo Scientific™ Dionex™ Chromeleon™ CDS meets all of your regulatory compliance needs with: • Multi-tiered security for controlling access with comprehensive user management tools • Comprehensive tracking of all actions without hindering workflow • History views of objects track changes and easily revert to prior versions • Complete record management with direct access to meta- data and full electronic signature support • Powerful built-in, automated qualification tools for all aspects of system operation
  31. 31. 32 Summary – Bringing It All Together Chromeleon CDS has all the tools to help you ensure regulatory compliance
  32. 32. 33 Thank You! Any Questions?

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