How Can a Validated CMMS Reduce My Risk of 483 Observations?

A review of the top 483 observations issued by the FDA indicates that many of them are related to the following categories:

  • Lack of written, approved procedures where required
  • Non-performance or insufficient performance of procedures
  • Non-performance or insufficient performance of validation, calibration, or maintenance
  • Insufficient follow up (e.g. CAPA) of failures

To be sure, there are many potential root causes for any of these issues, but one thing a company can do to have a great head start in preventing or resolving them is to have a validated, 21CFR11 compliant, CMMS system in place and in regular use.  Having these systems in place helps you track your equipment, know when the maintenance is due (or overdue!), and provides you quick access to records.  Additionally, you can easily identify non-conforming (e.g. out of tolerance) equipment and track the resolution of these problems to completion.

This means that if an inspector asks you about the history of an item, you can have it at your fingertips and don’t necessarily have to dig through all of your paper files to get to the requested information.  A product like GxPReady! Suite, for example, allows you to bring up the calibration certificate on the spot, if it is scanned in, and allows you to quickly answer any questions the auditor may have.

Imagine if an auditor asks you for a document and you have it at your fingertips, without having to run to the files or track it down somewhere in process in the company.  Life gets easier!

By comparison, if you use a spreadsheet system, the documentation is not easily available.  If you have only a hardcopy system, there is always the opportunity for a document to get mis-filed or lost.  Or perhaps the document is in another building, so you then have an uncomfortable delay while you wait for the document to be produced.

Taken together, a validated CMMS system can go a long way to providing you a little peace of mind that your maintenance, validation, and calibration are up to date and can take a lot of stress out of audits from internal QA, customers, and regulatory agencies.

With the advent of validated SaaS (web-based) systems, it is now easier than ever to get an affordable validated CMMS system for your use up and running in no time.  Of course, we have our opinion on what the best GxP CMMS system is for most companies, but just make sure the one you choose is designed for GxP use and is validated.  Otherwise you will compound your stress by trying to qualify a system that was not designed for that purpose and that will just make for a really tough audit.