managing the validation and migration from sas ® 9.1.3 to 9.2 on a new server carey smoak sy truong
TRANSCRIPT
Managing the Validation Managing the Validation and Migration from SASand Migration from SAS®®
9.1.3 to 9.2 on a New 9.1.3 to 9.2 on a New ServerServer
Carey SmoakCarey Smoak
Sy TruongSy Truong
OverviewOverview
Communicating the Validation Process
The Project Management Perspective Lessons Learned Conclusion
Communicating the Validation Process
The ProjectThe 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
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 ProjectThe 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 PerspectiveManagement Perspective
Do not underestimate: Time
>700 hours personally
Resources IT, Quality and
Consultant
Management PerspectiveManagement Perspective
Purchasing hardware and software Relatively easy task
Management PerspectiveManagement 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 PerspectiveManagement Perspective
Meet with IT, Quality and other personnel on a regular basis Keep the project
moving Ensure tasks are
completed on time
Management PerspectiveManagement 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 PerspectiveManagement 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 PerspectiveManagement 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 PerspectiveManagement Perspective
Start-up of the new SAS System IT approval Training of end-users
Management PerspectiveManagement Perspective
Hiring personnel with validation experience Be sure to hire someone with prior
validation experience
Lessons LearnedLessons Learned
Clearly defined test plan and protocol Flexibility due to technical issues
Lessons LearnedLessons Learned
Unexpected deviations Managing the resolution of deviations
Lessons LearnedLessons Learned
Good version control of documentation Share-point site
ConclusionConclusion
Do not underestimate: Time Resources
Contact InformationContact Information
Carey SmoakCarey Smoak
Roche Molecular Systems, Inc.Roche Molecular Systems, [email protected]
Sy TruongSy Truong
Meta-Xceed, Inc.Meta-Xceed, [email protected]