21 CFR Part 11: Definition
21 CFR Part 11 is a section of the Code of Federal Regulations (CFR). It defines US FDA’s guidelines regarding the use of electronic records and signatures for pharmaceutical and medical device companies.
The “21CFR” in 21 CFR Part 11 represents Pharmaceuticals and Medical Devices, while “Part 11” relates to electronic records and signatures.
Part 11
Part 11 of the CFR is a law that allows
- Replacement of any paper records with electronic ones
- The replacement of any handwritten signature with an electronic one.
This law ensures the implementation of good business by companies and organizations. It does so by defining the criteria by which electronic records and signatures are considered as
- Accurate
- Authentic
- Trustworthy
- Reliable
- Confidential
- The equivalent of paper records and handwritten signatures.
Timeline and History of 21 CFR Part 11
The initial work on devising rules and regulations for electronic record-keeping systems for pharmaceutical companies started in 1991 and was completed by 1997.
From 2000, FDA announced certain requirements for electronic records and electronic signatures. According to FDA:
- The compliance requirements for electronic records will be the same as the paper records
- Electronic signatures will be considered as equivalents of handwritten signatures.
Since 2000, FDA has released several guidance papers to cope with the constantly changing dynamics of the pharmaceutical and medical device industry. With these guidance papers, these companies can understand and interpret the rules of 21 CFR Part 11. The following list shows the guidance papers that FDA released from 1991 till 2007:
- 1991- Project launching
- 1992: Advanced notice
- 1994: Proposed rule
- 1997: Final rule
- 1999: Use of computerized systems in electronic records
- 2000: Electronic records
- 2003: Guidance document on “Scope and Application.”
- 2004: Guidance document on “Draft Computerized Systems Used in Clinical Trials.”
- 2007: Publication of Final Guidance.
Terms & Definitions in 21 CFR Part 11
Electronic Record
Any combination of text, graphics, data, audio, or pictorial information is represented in a digital form created, modified, maintained, archived, retrieved, or distributed by a computer.
Electronic Signature
A compilation of any symbol(s) executed to be the legally binding equivalent of an individual’s handwritten signature.
Handwritten Signature
The scripted name or legal mark of an individual, handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form.
Digital Signature
An electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the signer’s identity and the integrity of the data can be verified.
Scope of Interpretations of 21 CFR Part 11
Although the purpose of the law was to help scientific organizations implement required controls, its flexible nature of interpretation has created many difficulties and widespread confusion amongst the pharmaceutical and medical device companies. However, with constant revision and upgrades, the FDA has managed to eradicate some of this confusion.
Need of 21 CFR Part 11
By establishing a standard for electronic records and signatures in the form of 21 CFR Part 11, the FDA has imposed a significant impact on the life sciences, pharmaceutical, and medical device industries. The 21 CFR Part 11 has
- Streamlined business processes
- Reduced the turnaround time and cost-effectiveness.
Areas of Focus for Pharmaceutical & Medical Device Companies
Companies belonging to life-sciences industries, pharmaceutics, and medical device sector should focus on the following primary areas with concern to 21 CR Part 11:
Required Features
Regarding implementing a computer system for electronic record management, 21 CFR Part 11 requires companies to have a range of features in place. Some of them include:
- Audit trail functionality
- Electronic signatures
- Security and data integrity
- Records retention
- File formats.
SOP Compliance
Under 21 CFR Part 11, there are 9 IT SOPs addressing the IT infrastructure requirements. Companies deploying the computer system for electronic record management are required to show compliance to these IT SOPS.
System Validation & Compatibility
Before implementing the electronic system, the company should ensure that the system can perform according to its intended use. The company should also demonstrate the controls it will utilize if its electronic record management system does not function as intended.
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