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Hot Topics

• Updates for SAS 9.2 (March 2008)
  See the compatibility calculator to determine whether you need to migrate your libraries to SAS 9.2. Use the PROC MIGRATE calculator to find the right example code for your migration.
  
  
• Get a Smarter COMPARE
  Validation tools for the MIGRATE procedure now work with CEDA and provide additional details about catalogs, indexes, and integrity constraints.
  
  
• Start Planning
  See Getting Started for the most efficient pathway through all of the SAS®9 migration documentation.
  
  
• Coexistence
  Many SAS®9 products can install side-by-side with SAS 8.2 with very good compatibility. See Peaceful Coexistence: SAS®9 and SAS 8.2 for details.
  
  
• Sample Validation SOP
  See an example SOP: SAS Installation Qualification / Operational Qualification (PDF) (updated 19 May 2008) for the pharmaceutical industry.

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Industry-Specific Answers

Migration

Pharmaceutical Industry

FDA regulations under 21 CFR Part 11 have placed an increased interest by the biomedical industry on the requirements for migrating, integrating, and validating computerized systems.

To support these efforts by our customers, the SAS Life Sciences Organization has chartered a Migration, Integration, and Validation (MIV) Project. The mission of this project is to assist SAS users in the pharmaceutical, biotechnology, and medical devices industries in their efforts to identify, address, and comply with these issues in the clinical IT environment.

Through the MIV Project, SAS will help address the following questions, commonly asked by our customers, about implementing new versions of SAS:

• How do biomedical companies migrate data, code, and reports to a more current version of SAS in a validated manner?
  
  
• How do companies maintain assurance, initially and ongoing, in the installation qualification and operational qualification of the new SAS release?
  
  
• How do companies integrate and migrate in-house developed code and macro libraries with newer, Part 11-enabled SAS technologies such as SAS Drug Development?
  
  
• Can SAS assist the industry in the development of user acceptance and performance qualification testing?

Validation

SOP: SAS Installation Qualification / Operational Qualification (PDF)

is an example standard operating procedure (SOP) for use of the SAS Installation Qualification (SAS IQ) and Operational Qualification (SAS OQ) tools.

Validation

presents general information for the planning stage of a migration project.

Please contact the MIV Project Team via e-mail at migration.pharma@sas.com with questions or comments.