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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:

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