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