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 free 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, especially for small and mid-sized companies.