Paper PO17 Architecting a Regulatory Compliant Macro Library using SAS Drug Development

Centralized macro libraries can provide efficient solutions to project programming and analysis needs. They also may provide consistency of statistical methodologies, programming techniques and implementation of industry standards across projects. In the pharmaceutical industry, programming is required to comply with 21 Code of Federal Regulation (CFR) Part 11. This requires traceability of changes to programs or macros. Additionally, validation of programs or macros is needed to ensure they perform the functionality intended. SAS Drug Development (SDD) provides a regulatory compliant repository. This paper addresses the challenges of architecting a centralized macro library stored in SDD for use in analysis and reporting