21 CFR Part 11 requires Food and Drug Administration (FDA)-regulated industries, including medical device manufacturers, drug makers, biotech companies and biologics developers, to have validation documentation and implement controls such as audit trails and electronic signatures
R&D-driven industries talk a lot about progressing towards the paperless laboratory. The ultimate aim is to capture and store all experimental, process, inventory and results data, from the earliest stages of discovery, through to manufacturing, QA/QC and even instrument management, in an electronic format
Data governance is an integral part of a regulated company’s quality system. Having a chromatography data system can simplify system administration and ensure regulatory compliance (including 21 CFR Part 11) and adherence to data integrity guidelines.
Audit trails are considered the key to the security of a system since they track changes to data and metadata. In this way, an incomplete or absent audit trail can impact data integrity or even product quality. The absence of an audit trail is considered to be, “highly significant when there are data discrepancies” according to the FDA.
Today, laboratory-based organizations face a wide variety of unaddressed data management challenges, and yet ultimately the scientific data is the currency with which they trade. Proper data management may not pay shareholders but it fundamentally defines the integrity of the organization and it’s purpose for existing. Being the cheapest, the fastest or the most definitive is desirable but it is all meaningless if the data is untrustworthy.