Spreadsheet Life Cycle Management for Part 11 Compliance

The United States Food and Drug Administration’s (FDA) modern regulatory function started with the 1906 Pure Food and Drugs Act and continues through 21 CFR Part 11, which details the criteria for reliable electronic records and signatures as used in pharmaceutical and medical device manufacturers, bio tech companies, research labs and clinical trials. Commonly referred to as Part 11, the regulation calls for controls such as system validations, audits, audit trails, documentation and electronic signatures to make certain predicate rules created for paper documentation can be applied to electronic documents as a means of ensuring the accuracy, reliability, integrity, availability, and authenticity of required records.

This white paper explains how these predicate rules apply to electronic records and how a sustainable compliance approach to the life cycle management of spreadsheets, comprised of repeatable business processes, can help in the areas of inventory and risk assessment, validation or re-validation or deploying a 21 CFR Part 11 control environment.