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Viscosity And 21 CFR Part 11 Compliance


What is 21 CFR Part 11?

Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.

Practically speaking, Part 11 applies to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries. It requires that these companies implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing the electronic data that FDA predicate rules require them to maintain. 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.


Does 21 CFR Part 11 Apply To Me?

In a nutshell, probably. For the first part, 21 CFR Part 11 is about electronic records and record keeping, while the second part governs electronic signatures. It sets out how companies must consider them.

With the advancement of computer systems, the distribution of work places and storage in the cloud, it is just not practical to stick with a paper-based system if you have offices in more than 1 location.

Also, in section 11.3, the FDA defines "electronic record" to mean; "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." As you can see, this makes the definition covered by Part 11 quite broad and most companies will be affected.


Why Is Compliance Important To Viscosity Testing?

Viscosity behaviour allows manufacturers to understand and gather key information about their product. Based on the viscosity readings, one can predict things like pourability, performance in a dipping or coating operation, or the ease with which a product can be applied, processed, or handled.

In addition to this, the measurement of viscosity is often the best way of detecting any changes in colour, density, stability, solids content, and molecular weight.

This is why Viscometers are such a crucial part of research, development, and process control programs. Especially in some industries, like pharmaceuticals or cosmetics, where being able to have full traceability of your processes is so important.

Having a 21 CFR Part 11 Compliant Viscometer and Software package can make your life much easier.


How Can Brookfield Ametek Make Me Compliant?

The Brookfield Ametek Touch Screen Viscometers and Rheometers (example: DV2T, DV3T and RST) are 21 CFR Part 11 Compliant.

Furthermore, the Brookfield Ametek RheocalcT Software boasts secure 21 CFR features including:

  • Stored Test Methods re-run on instrument for repeatability
  • Test Methods stored on PC for unattended operation
  • Test Methods locked for modification by operator
  • Multiple access levels
  • Password access restrictions
  • Digital signatures
  • Data results storage in a password-protected database.


Where Can I Find Out More About Viscosity?

You can find out more about the Brookfield Ametek 21 CFR Part 11 compliant software and the full Brookfield Ametek Viscometer range on our website. If you have a need that is not covered in this range, please contact our Sales Team.

You can also find more information on our Viscosity FAQ page.

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