The Food and Drug Administration’s Code of Federal Regulations Title 21 Part 11 (FDA 21 CFR Part 11) helps streamline compliance with a wide range of FDA regulations by supporting FDA-regulated industries in their efforts to submit necessary documentation in an electronic format. In particular, 21 CFR Part 11 provides regulations that enable manufacturers to use electronic records and signatures in a manner equivalent to paper-based records and handwritten signatures.

This regulation specifies that 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 about 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 fulfill these demands. Because Epicor builds the necessary capabilities into its products, implementation is fast, easy, and comprehensive.

 

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About Encompass Solutions

Encompass Solutions is a business and software consulting firm that specializes in ERP systems, EDI, and Managed Services support for Manufacturers and Distributors. Serving small and medium-sized businesses since 2001, Encompass modernizes operations and automates processes for hundreds of customers across the globe. Whether undertaking full-scale implementation, integration, or renovation of existing systems, Encompass provides a specialized approach to every client’s needs. By identifying customer requirements and addressing them with the right solutions, we ensure our clients are equipped to match the pace of the Industry.