Product manufacturers: Is your document management software keeping you 21 CFR Part 11 compliant?


What is FDA Title 21 CFR Part 11?

Commonly called “Part 11”, Title 21 CFR Part 11 defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.

In a nutshell Part 11 requires all drug makers, medical device manufacturers, biotech companies, biologics developers, CROs and other FDA-regulated industries (with some exceptions) to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are (a) required to be maintained by the FDA predicate rules or (b) used to demonstrate compliance to a predicate rule. A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11.


What’s the big deal about being compliant with FDA Title 21 CFR 11?

Well, if you fall into the category of a manufacturer who is in any way regulated by the FDA, it’s big. Very big. Failure to be compliant can mean hefty fines from the FDA and a legal process that could deliver a black eye or even a fatal blow to any FDA-regulated manufacturing company, large or small.


So what document management system will help my company be compliant with 21 CFR 11?

Answer: eFileCabinet
Choosing the correct DMS for you company to be compliant with 21 CFR Part 11 can be a daunting task. However it doesn’t have to be. IT and QC departments should keep in mind that document management software (in order to be used effectively) must be adaptable  to the company’s manufacturing process, and must be usable each person who needs access to  the software. So, in addition to making sure your DMS is compliant with 21 CFR 11, ask yourself: Is our solution software intuitive and simple to use?

The requirements of 21 CFR Part 11 are somewhat complicated, which makes the process of implementing a solution to  comply with that regulation also tricky.  In addition to the fact that our software capable of being used  by thousands of customers to  represent their respective  compliance workflows, eFileCabinet possesses the know-how to set up a document management system that  meets the demands of Part 11, and we carefully walk customers through a set-up and implementation procedure that simplifies the process for them.


Question: How can eFileCabinet’s document management software help in being compliant with 21 CFR 11?


  • eFileCabinet will help generate accurate and complete copies of records in both human readable and electronic form.
  • eFileCabinet is a software system that has the ability to validate and ensure accuracy, reliability, and consistent intended performance, and it also has the ability to discern invalid or altered records.
  • eFilecabinet can be set up to protect records and ensure their accurate and ready retrieval throughout the records retention period.
  • eFilecabinet’s role-base security function limits system access to authorized individuals.
  • eFilecabinet’s audit function ensures computer-generated, time-stamped audit trails.