White Paper: 21 CFR Part 11 Compliance - 6 Key Factors Every FDA Regulated Firm Should Know

• By: ComplianceOnline
• Date: July 08, 2014

21 CFR Part 11 specifies requirements for handling electronic records and electronic signatures and applies to any records covered by FDA regulations that exist in an electronic form. The main objective behind implementing this regulation was to prevent fraud while facilitating, promoting the possible use of electronic technology to reduce expenditures incurred from paper sources.This white paper provides an overview of FDA requirements for electronic systems and the applicability of 21 CFR Part 11. It also details consequences for non-compliance and six key aspects FDA regulated firms should focus on so as to ensure compliance.

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