Best Validated CMMS Software

Ok, so I will admit that we are a little biased.  But that doesn’t mean we aren’t right.  There are 3 major reasons you may be looking for a validated CMMS software:

  1. Compliance – You need a compliant system to meet basic federal requirements including 21CFR11.
  2. Asset Management – You need to track your equipment and document what the GMP impact is of the equipment and set up schedules for the work.
  3. Event Tracking – You need to be able to schedule work, and document the work performed.

There are 4 major drawbacks that are normally associated with acquiring a validated CMMS system:

  1. Cost – Wow!  Just for a little compliance, the cost goes through the roof compared with any standard non-validated CMMS system!  And then upgrades, per-user licenses, per item costs, long commitments, etc.
  2. Time – Well, until now there was a ton of research required.  Figuring out what features you need for compliance, drafting and executing protocols, etc.  This can take months for some systems and many systems can’t be validated in any reasonable amount of time.
  3. Transferring Data – Ok, so once you have a new system, how do you get the data there from whatever you are using now?  And, just as important, if you outgrow the system (and you can outgrow any system) how can you get the data to the new system.
  4. Compliance – Can you trace your requirements to the system validation?  That is, if you are asked by an auditor, can you find the testing that supports YOUR specific requirements in the validation package?  Or can your validated CMMS system supplier?

Once you have a system in place (which can take a while for highly configurable systems), it needs to be usable.  Some of the features you may want:

  1. Security and Audit Trail – this should be standard with any validated CMMS system and basic requirements for 21CFR11 compliance.
  2. Ease of Use – “Intuitive” and “validated” can be opposing forces if the software is not well designed.  Workflows can be complicated and require a significant amount of staff time to implement, even after the setup.  If it takes more than a few minutes to enter a record, then you can see how that time can add up.  If it takes more than an hour or two to train on the CMMS system, is it really easy to use?
  3. Reliable Recall Reports – Of course, to schedule work, you have to have reports that indicate when the work is due and communicate that to the responsible parties with verification in place to ensure that the communication was successful.  Emails or texts may not reach their destination for a variety of reasons.
  4. Document Attachment –  The ability to attach reports and data sheets, manuals and drawings, etc.  This is much faster than typing in reams of data and having to re-verify all of the data entry.
  5. Traceability – for out of tolerance (OOT) calibrations, and other commonly used reports.
  6. Electronic Forms and Signatures – These can be handy to solve problems of illegibility and can make routing easier.  The software package should ideally be able to work with e-signature systems you have in place to keep costs down.

GxPReady! Suite has been designed from the ground up for compliance with FDA and EMEA requirements including 21CFR11 and Annex  11.  This product was designed to address the fact that there is no other option in a reasonable price range that meets the key requirements for a validated CMMS system with such a low cost and quick start up.  Moreover, the GxPReady! Suite system was designed by professionals in the pharmaceutical industry that have deep experience with calibration, maintenance, and validation, not by a software development company using a patented system for ease of validation.

No long contracts, per user costs, per item charges, and we can transfer data from/to other systems.

Contact us at [email protected] for additional information and compare us to what you have seen so far in your search for validated CMMS software.  You can get up and running at a fraction of the time and cost of other options.