DIGITAL COMPLIANCE: NAVIGATING THE FUTURE WITH 21 CFR PART 11

Mrunal S. Kikale*, Nilam D. Chingale, Sushil D. Walunj, Omkar A. Devade and Vivek Kumar Redasani

ABSTRACT

21 CFR Part 11, titled "Electronic Records; Electronic Signatures," is a regulation established by the USFDA. Enacted in 1997, this regulation governs the use of electronic records and electronic signatures in industries subject to FDA regulations, primarily the pharmaceutical, biotechnology, and medical device sectors. The main purpose of 21 CFR Part 11 is to ensure the reliability, authenticity, and integrity of electronic records and signatures used in regulated industries. It outlines requirements for the use of electronic records and signatures to ensure that they are trustworthy and equivalent to traditional paper records and handwritten signatures. Key provisions of 21 CFR Part 11 include requirements for: Validation of electronic systems, Access controls, Audit trails, Electronic signatures, Record retention and archiving. Compliance with 21 CFR Part 11 is essential for companies operating in regulated industries to ensure the safety, efficacy, and quality of their products. Non-compliance can result in regulatory action, including warning letters, fines, or even product recalls. Overall, 21 CFR Part 11 represents a critical regulatory framework that enables the adoption of electronic recordkeeping systems while maintaining the highest standards of data integrity, security, and accountability in the pharmaceutical and healthcare industries.

Keywords: FDA, Code of Federal Regulation, Electronic records, Electronic signatures, Open system, closed system.