This short video explains, in simple terminology,
what Computer System Validation is,
and how it saves your company money!

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21 CFR Part 11 is a law that ensures companies implement good business practices. Part 11 allows a company to implement computer systems that will greatly increase the efficiency of individuals, reduce errors by identifying risks, and increase overall productivity of the company.

The Code of Federal Regulations (CFR) contains the laws for each of the government agencies. Each title of the CFR addresses a different regulated area. Laws typically refer to records and approval signatures, which originally referred to paper documents and handwritten signatures. Part 11 allows any paper record to be replaced by an electronic record, and allows any handwritten signature to be replaced with an electronic signature.

While Part 11 is an essential and very successful law, there has been much controversy and misunderstanding about it. The law is less than three pages long and doesn't give much detail about electronic records and signatures. Don't be mislead by the almost 30 pages of preamble material that is not the law. Just go to the end of the Part 11 document and flip back three pages to the beginning of the law. Adding to the confusion is the rapid evolution of computer technology that has made 21 CFR Part 11 compliance a moving target.

Computers have made people much more productive, so it is natural to use electronic records in place of paper records. Every company has electronic records, and most companies are so unsure about electronic signatures that they print out copies of electronic records and sign the paper. What these companies don't understand is that it doesn't take much effort to become FDA 21 CFR Part 11 compliant for both electronic records and signatures. Can you imagine a company with a lot less paper? With Part 11 this is not only possible, it is happening every day in companies all around the world.

As all regulated companies know, the company's Standard Operating Procedures (SOPs) describe how processes are to be performed. In the implementation of those processes, Part 11 allows any paper record to be replaced with an electronic record provided the computer system has appropriate features and is validated.

There are four primary areas of 21 CFR Part 11 compliance:

1. SOPs - There are about a dozen SOPs needed to address the IT infrastructure. They address Data Backup, Data Security, Computer System Validation, and other aspects of computer systems that support electronic records and signatures.

2. System features - There are more than 40 industry standard features that are implemented to ensure the computer system is secure, contains audit trails for data values, and ensures the integrity of electronic signatures.

3. Infrastructure qualification addresses hardware and software components, including virtualization. It is applicable to local installation and Software as a Service (SaaS) hosted platforms.

4. Computer System Validation - Every computer system must have documented evidence that the system does what is intended and that users of the system can detect when the system is not working as intended. Validation must follow the company's SOPs, and virtually all companies find the risk-based approach to computer system validation to be the most efficient and cost effective method of validation available.

The key to FDA 21 CFR Part 11 compliance is to use the law to your benefit, and not try to ignore it or circumvent it. When you buy a computer system to become more productive, doesn't it make sense to use Part 11 to maximize productivity?

David's Books

One of the nation's foremost experts on CSV for 21 CFR Part 11, David Nettleton has written four books with Janet Gough:

Risk Based Software Validation
Risk Based Software Validation - Ten easy Steps

Electronic Record Keeping
Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164

Managing the Documentation Maze
Managing the Documentation Maze
Read a Review

Commercial Off the Shelf COTS Software Validation
Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance

See the Books page for more information and to order.