What is the relevance of 21 CFR Part- 11 in Pharmaceutical Analysis?

21 CFR Part 11 is the section of the US FDA’s Code of Federal Regulations governing electronic records and electronic signatures in pharmaceutical and medical device operations, establishing that such records and signatures can be treated as accurate, authentic, and equivalent to their paper and handwritten counterparts.

Electronic Signature has Universal acceptance

The United States Food and Drug administration (USFDA) has laid down guidelines on using electronic signatures and records through Code of Federal Regulations. Each section refers to a specific regulated area. 21 CFR refers to Pharmaceutical and Medical devices and Part 11 reference to electronic records and electronic signatures.

The basic assumption is that electronic records and signatures are accurate, authentic, trustworthy, reliable, confidential and equivalent to paper records and handwritten signatures. Part 11 permits paper records and handwritten signatures to be replaced by electronic versions. Adoption of 21 CFR Part- 11 guidelines is voluntarily and represents minimum requirements for implementation but should the laboratories decide they can make their systems even more secure.

What are electronic records and electronic signatures?

Electronic records are defined as any combination of text, graphics, data, audio, pictorial, or other information in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.

Electronic signature is a compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be legally binding as the individual’s handwritten signature.

Relevance of 21 CFR Part- 11 to Pharmaceutical testing laboratories

Pharmaceutical testing laboratories are placing more and more reliance on computerized analysis and Internet to get the following benefits:

• Speed of data transmission through electronic means
• Selective and secure access to data
• Reduce human handling errors and achieve greater reliance on electronic data transfer
• Reduce paper handling costs

Pharmaceutical testing laboratories require a robust data security for the upkeep of user and client confidence and protection from legal liabilities. Internet is a general public network and there is a need for higher security levels that permit only authorized and tamper free access. This becomes possible through compliance with minimum conditions prescribed in 21 CFR Part- 11 regulations. The driving force for implementation of 21 CFR- Part 11 is to prevent fraud through human handling and ready access to paper records.