CMMS Software and 21 CFR 11 Compliance, Part 1: What You Need to Know

16th February 2016

Today I got a phone call from an MPulse customer, Eric, who is a maintenance manager at a biotech company. He’s planning a maintenance software upgrade, and he had a good question:

“Steve, I’ve got a coworker telling me our CMMS solution needs to be 21 CFR 11 compliant. Is MPulse Software certified for 21 CFR 11?”

That’s a great question, but the answer isn’t simply “Yes” or “No.”

What is Title 21 CFR, Part 11?

If you work in the pharmaceutical, medical device, biotech, or related industry, Title 21 CFR Part 11 is a major part of your operations.

The name refers to the part of Title 21 of the Code of Federal Regulations that establishes the U.S. Food and Drug Administration (FDA) regulations on electronic records and electronic signatures—defining the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.

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16th February 2016

Naturally, 21 CFR 11 compliance is closely tied to software. And in the maintenance department, that software is—of course—CMMS software.

Can CMMS Software Be 21 CFR 11 Certified?

Eric’s question, however, relates to a common misconception about software and compliance. To be Title 21 CFR 11 compliant, Eric’s organization must show it has…

  1. Procedural controls
  2. Administrative controls
  3. Technical controls.

Now a software vendor can provide the technical elements of a 21 CFR 11 compliant system, which MPulse Software factors—procedural and administrative controls—relate to the organization’s process, not the tool.

So the answer to Eric’s question is MPulse Software provides the technical elements of a compliant system. However, we do not claim compliance as the bulk of compliance is related to the use of the tools, not the tools themselves.

As such, there is no recognized certification process for software developers. Just like you cannot buy a 21 CFR 11 compliant socket wrench, you cannot buy 21 CFR 11 compliant software.

It’s an important distinction that is sometimes not fully understood.

However, CMMS software is the best tool for maintenance departments to achieve the technical controls for 21 CFR 11 compliance as well as other regulatory certifications like ISO or HIPAA or Sarbanes-Oxley. Next time, I’ll outline the possibilities for you.

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