How 21 CFR Part 11 Supports GDocP Requirements
Updated: Jun 6
There’s a common saying in life sciences: if it’s not documented, it didn’t happen. This is shorthand to describe the industry standard attributes of good documentation practices (GDocP), which is also captured in the acronym ALCOA – attributable, legible, contemporaneous, original and accurate. These documentation attributes are not just standard, but they are required by some of the largest governing bodies like the World Health Organization (WHO) and Food and Drug Administration (FDA). While reviewing this overview, consider how your organization implements and and enforces ALCOA. Does your current process leave something to be desired?
21 CFR Part 11 is specific to electronic records and signatures. It came to fruition back in the 1990s when computer systems were becoming more common to manage life science company records, including manufacturing records. The problem at the time was that the ALCOA principles of electronic documentation were not guaranteed with the systems in use, and that could have compromised the integrity of products for human use or consumption. Since 21 CFR Part 11 incorporates requirements for both open and closed systems, electronic signatures, and signature to record linking, the government is able to ensure that safe and effective products are supported by strong documentation.
Good documentation practices are just one element of GxP regulations, and even that one area has many nuances. For additional assistance or more information on how we can help your organization achieve compliance, contact us today for a free consultation!