The Requirements of FDA's 21 CFR Part 11 and Software Programs That Meet the Requirements

With the increased use of electronic records in the Biotechnology Industry, there became a need for requirements to address data security, data integrity and traceability of this data. In response, the Food and Drug Administration (FDA) published a regulation called 21 CFR Part 11 (August, 1997.) The intent of the new regulation was also to promote the use of electronic technology. The regulation provides Biotech companies with the requirements that enable them to move toward electronic record keeping while still maintaining data security, integrity and audit traceability. The implementation of the requirements addressed by 21 CFR Part 11 have been slow because there have been many questions regarding the scope and interpretation of the requirements, the potential high costs, and lack of technical solutions. This paper provides a high level view of the requirements of 21 CFR Part 11 and then discusses a few of the commercially available technical solutions that currently exist to meet FDA's 21 CFR Part 11 requirements. Each software program is addressed individually, starting with a high level overview of the tool, including reviews from sources in the industry. Then, each tool is compared against the 21 CFR Part 11 requirements in a table for easy evaluation.