3 Critical Requirements for Validated CMMS Software (and why review sites are hard to use for evaluation)

Ranking the top CMMS Systems

Selecting the best validated CMMS system for your companies use is not as easy as just going to a web site.

There are many CMMS software products out there these days, but if you are operating in an environment that requires compliance with cGMPs, then you will find that it is a much more limited selection of companies that are available. This is intended to help you quickly narrow down the validated CMMS options that may work for you. The following is a suggestion about the critical questions you can ask to quickly narrow down the scope of your search. Unfortunately, most of these parameters are not presented clearly on many of the CMMS evaluation sites, so you need to do a little of your own legwork to find out which system is the best for you.

  1. The system must be designed for GMP compliance. An off-the-shelf system that is not designed for validation and compliance with 21CFR11 and/or Annex 11 will almost certainly not meet those requirements. This eliminates the vast majority of options, yet it is typically not a criterion you can set in most software comparison sites. In fact, this concept is not even understood by most of the sites that purport to help you choose a CMMS system. This would be a valuable addition to the available criteria.
  2. The system should be validated to ensure that it meets your requirements for a CMMS software, and the traceability from your reviewed and approved requirements to the validation of the CMMS software should be available. It can be a challenge to find systems that are traceably validated to your requirements. Typically, these requirements will include the following at a bare minimum:
    • Documentation of the affected equipment and systems, work performed, and supporting records
    • The ability to generate a list of equipment due for calibration, maintenance, and/or validation during a specified time period
    • Traceability for out of tolerance (OOT) equipment to allow evaluation of the impact of the OOT and ensure they are resolved
    • The ability to schedule dates for work to be performed
    • Compliance with electronic signature and records requirements
    • A robust yet flexible security system
    • Installation on a validated platform
  3. Everything else. Once you have narrowed it down to a system that is compliant and meets your basic requirements, you will have a list of potential providers and the selection comes down to your preferences with regard to price, setup time, and features. With GxPReady! Suite, we have worked to ensure that we meet all of the compliance requirements with the best value, most convenient onboarding, and quickest startup time. We hope that you will agree, even if it takes a little while to sort out the GMP capable systems from all those others out there!