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Why FDA Title 21 CFR Part 11 matters more than ever - Part 1

April 5, 2018

This three-part blog series revisits an age-old topic through the lens of the latest technology. Starting with a brief introduction to the history of Title 21 CFR Part 11, we’ll take you through the industry changes that enable better data reliability and significant performance improvements over the traditional use of electronic signatures.

Part 1: History

Just over 20 years ago, the FDA introduced “Title 21 CFR Part 11: Electronic records and electronics signatures”.  For the better part of those 20 years, the FDA has been expanding and clarifying the scope of this guidance.

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The fundamental purpose of Title 21 CFR Part 11 is to ensure companies implement sound business practices by defining the criteria by which Electronic Records and Electronic Signatures (ERES) are considered to be accurate, authentic, trustworthy, reliable, confidential, and equivalent to paper records. (Source: FDA). Basically, how to securely replace any paper record with an electronic one, and any handwritten signature with an electronic version. One important note: All electronic records that are used for regulated purposes are subject to Part 11.

There are a number of terms used in Part 11, so let’s pause here and highlight how the FDA is defining some of the more commonly used terms:  

  • Electronic record: Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.
  • Electronic signature: A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.
  • 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 identity of the signer and the integrity of the data can be verified.
  • 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. The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark.
  • Closed system: An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.
  • Open system: An environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system.
  • Biometrics: A method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable.

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The history of Part 11 goes back to 1991 when the FDA, alongside key stakeholders in the pharmaceutical industry, started the project with the goal of tackling electronic record keeping while maintaining Good Manufacturing Practices (GMP). The title was officially launched August 20th, 1997 -the original rule intentionally striving to maximize flexibility without being overly prescriptive. This flexibility, however, though intended as a benefit, left Part 11 open to interpretation and resulted in increased confusion for the pharmaceutical industry, as it lacked the “standard” that manufacturers wanted.

Over the next two decades, iterative updates, amendments, and guidance documents managed to add clarity to Title 21 CFR Part 11, and in 2007, issued the final version of their guidance on computerized systems in clinical investigations. What exists now is a considerably more comprehensive guideline for companies to follow. Still, the FDA has left it open-ended to some degree, as a way to “futureproof” the rule.

So, why view Title 21 CFR Part 11 positively? Prior to this CFR, pharmaceutical manufacturing companies had no standards for ERES and this led to a fractured patchwork of systems across both the manufacturer and industry as a whole. This created a problem that resulted in major inefficiencies along the entire manufacturing process and supply chain. Being inefficient leads to increased operating costs and delays in the go-to-market timeline. With Part 11, companies now have a target that sets baseline criteria for the use of ERES. This has allowed companies to streamline processes and has expedited speed-to-market, both good things for manufacturers.

 

Next blog post we’ll be taking a look at how to ensure compliance with Title 21 CFR Part 11.


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