Managing the Validation and Migration from SAS ® 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 Upgrade from a Windows 2000 to a Windows 2003 server Migrate files from old to new server Upgrade from SAS on the old server to SAS 9.2 on the new server

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

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

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

Management Perspective Purchasing hardware and software Relatively easy task

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

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

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)

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

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

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

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

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

Lessons Learned Unexpected deviations Managing the resolution of deviations

Lessons Learned Good version control of documentation Share-point site

Conclusion Do not underestimate: Time Resources

Contact Information Carey Smoak Roche Molecular Systems, Inc. Sy Truong Meta-Xceed, Inc.