In particular, 21 CFR Part 11 provides regulations that enable manufactures to use electronic records and signatures in a manner equivalent to paper-based records and handwritten signatures.
This regulation specifies that in order to use electronic records and signatures, companies must meet four conditions. They must validate the software and systems used to create and maintain electronic records, provide secure access to those records to maintain confidentiality and data integrity hold individuals accountable for their electronic acts with regard to electronic documents, and ensure that electronic signatures cannot be repudiated.
However, the FDA does not specify how companies must address these requirements – rather it provides a set of guidelines based on common sense and good workflow processes.
This whitepaper describes the requirements for FDA 21 CFR Part 11 compliance at a high level and discusses how Epicor enables FDA regulated manufacturers to fulfil these demands. Because Epicor builds the necessary capabilities into its products, implementation is fast, easy and comprehensive, especially for small and mid-sized companies.