A technician is trying to figure a cost to validate a CMMS.

What is the the cost to validate a CMMS?

You’ve determined that your CMMS needs to be validated.  Then you’ve decided what functions you want to have.  Now, you have to make it happen and you have to see what the cost to validate a CMMS that you have chosen will be.  You may want to consider the following:

Starting With a Non-validated CMMS

Maybe you are working at a company and the CMMS isn’t validated, yet you need to be compliant.  So you can either buy a validated option, or work through the cost to validate the CMMS that you are currently using.

The cost to validate a CMMS is highly variable since there are so many ways your system can be set up.  It could be a spreadsheet, for example.  Or it could be a system that wasn’t originally designed for validation. These are the two most common options that people have in use when making this decision.

Option 1: Validating a Spreadsheet

If you are looking at the cost to validate a CMMS that is spreadsheet based, refer to our post “Can you validate a CMMS spreadsheet?”.

Option 2: Validating a Non-validated System

If you are more interested in the cost to validate another system not designed for validation, you need to make sure you have control of the system.  Typically, a system that wasn’t designed for compliance will not have the controls or documentation in place to allow for a proper validation.  The problem is that even if you write requirements and you can show that it meets the requirements you wrote, the manufacturer could come up with a revision or make changes that you can’t control.  As soon as that happens, you will be out of compliance.  Therefore, this is not a recommended practice per GMPs.

Option 3: Starting From Scratch

you may be able to validate software in compliance with 21CFR11  and/or Annex 11:

  • if you designed your own software;
  • if have traceability to requirements that are approved;
  • if you have a solid audit trail

Now add up the hours and expenses for:

  • writing and approving requirements
  • coding
  • testing
  • documentation
  • validation
  • maintenance/backups
  • change control

You will start to get the idea of the cost to validate a CMMS that is custom built.  In most cases, this is not a cost effective option.

Option 4: Find a Validated CMMS

Finally, you may want to consider the cost to validate a CMMS that has been designed for validation from the beginning.  There are many options, starting with a product like GxPReady! Suite, which is on the economical side and is easy to use without a ton of resources or data entry burden.   Or there are more complex systems that can run into tens of thousands of dollars and higher per year. They require significant configuration and data entry support by the users.

It is a good idea, if possible, to try the software before you buy it.  Many providers have free trials.

The ability and cost to validate a CMMS is important when selecting a CMMS that will work for you.  Stay tuned for additional tips!  Or contact us and we’d be happy to provide additional information.