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Managing the Validation and Migration from SAS ® 9.1.3 to 9.2 on a New Server

Managing the Validation and Migration from SAS ® 9.1.3 to 9.2 on a New Server. Carey Smoak Sy Truong. Overview. Communicating the Validation Process The Project Management Perspective Lessons Learned Conclusion. Communicating the Validation Process. The Project.

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Managing the Validation and Migration from SAS ® 9.1.3 to 9.2 on a New Server

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  1. Managing the Validation and Migration from SAS® 9.1.3 to 9.2 on a New Server Carey Smoak Sy Truong

  2. Overview • Communicating the Validation Process • The Project • Management Perspective • Lessons Learned • Conclusion

  3. Communicating the Validation Process

  4. The Project • Upgrade from a Windows 2000 to a Windows 2003 server • Migrate files from old to new server • Upgrade from SAS 9.1.3 on the old server to SAS 9.2 on the new server

  5. The Project Technical issues published in WUSS paper Use of SAS macro for PQ Use of checksums to verify that files were migrated properly.

  6. The Project • Validation Goals • To ensure that the installation and implementation of the SAS system functions as intended • Meets regulatory standards such as 21 CFR Part 11

  7. Management Perspective • Do not underestimate: • Time • >700 hours personally • Resources • IT, Quality and Consultant

  8. Management Perspective • Purchasing hardware and software • Relatively easy task

  9. Management Perspective • Follow company’s validation standards • Spend as much time as necessary understanding your company’s standards • Consult with Quality and IT to understand these standards

  10. Management Perspective • Meet with IT, Quality and other personnel on a regular basis • Keep the project moving • Ensure tasks are completed on time

  11. Management Perspective • Writing and execution of validation documents • User requirements / specifications • Validation plan • Change management plan • Traceability matrix • Test scripts • Protocols and reports (IQ/OQ/PQ)

  12. Management Perspective • Writing and execution of validation documents (continued) • Time and attention to detail • Perform test runs of the test scripts and adjust documents as needed • Proper documentation • Independent verification of validation results

  13. Management Perspective • File migration from old to new server • 22 hours to copy all files from old to new server • Checksums can be used to verify that the files were migrated properly • 13 hours to perform checksums

  14. Management Perspective • Start-up of the new SAS System • IT approval • Training of end-users

  15. Management Perspective • Hiring personnel with validation experience • Be sure to hire someone with prior validation experience

  16. Lessons Learned • Clearly defined test plan and protocol • Flexibility due to technical issues

  17. Lessons Learned • Unexpected deviations • Managing the resolution of deviations

  18. Lessons Learned • Good version control of documentation • Share-point site

  19. Conclusion • Do not underestimate: • Time • Resources

  20. Contact Information Carey Smoak Roche Molecular Systems, Inc. carey.smoak@roche.com Sy Truong Meta-Xceed, Inc. sy.truong@meta-x.com

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