FDA 21 CFR Part 11 Compliance Solutions

The Food and Drug Administration (FDA) published a set of rules in March of 1997 to facilitate electronic recordkeeping in the industries that it regulates. Part 11 of Title 21 of Code of Federal Regulations (CFR), Electronic Records seeks to ensure that information in electronic forms is secure. The rules also encourage the use of digital signatures. In 2003 the FDA issued a guidance that introduced the concept of risk analysis and promoted the formal process of risk assessment to determine appropriate security measures under the rule.

Impact on Pharmaceutical Industry The FDA’s 21 CFR Part 11 and HIPAA impose serious consequences on pharmaceutical companies that fail to protect information stored in electronic databases and accessed over private or public networks. The pharmaceutical industry is most seriously impacted directly by Part 11. This rule was designed to prevent fraud while encouraging the use of electronic documents and electronic signatures to reduce the cost and streamline the process of developing, testing, and manufacturing new life-saving and life-enhancing drugs.

21 CFR Part 11 requires security controls to ensure:

• Authenticity
• Integrity
• Confidentiality
• Non-repudiation
• Authorization
• Accuracy and reliability
• Audit trails

ecfirst.com, an Inc. 500 business, can help you with your 21 CFR Part 11 challenges and priorities. ecfirst.com solutions help your organization implement the security controls required by the FDA regulation. Call Lorna Waggoner at 1.877.899.9974 x17. Talk to us to learn more about our FDA compliance solutions.

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