Industry-Specific Answers
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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
- presents general information for the planning stage of a migration project.