Software used within FDA-regulated industries, such as pharmaceutical manufacturing and medical device development, must adhere to strict guidelines regarding data integrity and auditability. These guidelines, outlined in Title 21 CFR Part 11 of the Code of Federal Regulations, define the criteria for electronic records and electronic signatures to be considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures. For instance, a laboratory information management system (LIMS) used to track drug samples would need to meet these standards to ensure the accuracy and reliability of test results submitted to the FDA.
Adherence to these regulations is crucial for ensuring the safety, efficacy, and quality of regulated products. Meeting these requirements facilitates traceability, prevents data manipulation, and provides a clear audit trail, building trust in the data submitted to regulatory bodies. Historically, the introduction of this standard represented a shift towards embracing digital technologies while maintaining rigorous quality control within heavily regulated sectors. The use of compliant systems reduces the risk of regulatory non-compliance, potentially avoiding costly delays, fines, or product recalls.
