Title 21 CFR Part 11 of the US Code of Federal Regulations became effective on 20 August 1997 and defines criteria under which the FDA accept:
electronic records and electronic signatures as trustworthy, reliable and equivalent to paper records and handwritten signatures executed on paper
To ensure that a supplier's electronic records stored on BOMcheck comply with Title 21 CFR Part 11 requirements, there need to be two types of controls in place:
- Administrative and procedural controls which must be implemented and maintained by the supplier. These administrative and procedural controls are contained in the BOMcheck Member Rules for Suppliers. Failure to comply with these Member Rules can result in termination of the Membership by ENVIRON.
- Technical controls which are provided by the BOMcheck database.
The document below explains these two types of control in detail, and how compliance with the Supplier Member Rules will ensure that a Supplier's electronic records comply with Title 21 CFR Part 11 requirements, and are equivalent to paper records with handwritten signatures executed on paper.
Electronic Records and Signatures: Compliance with Title 21 CFR Part 11 Requirements