5 Questions to Consider When Purchasing Validated CMMS Systems

Our calibration management system is designed for ease of use.

Operator using the GMP CMMS system GxPReady! Suite to enter an equipment record.

Prior to developing GxPReady! Suite, we founders have had the experience of trying to find software for use in tracking calibration, validation, and maintenance management.  There are a ton of CMMS systems available out there, so you would think that there is no reason for us to develop something new.  However, once you go through the experience of going through all of the available systems, it is actually easy to find that none of them meet your needs.  Perhaps we can help you in your search by highlighting some of the questions that can help you narrow down the options without too much effort.  Consider the following 5 questions:

  1. Is the system developed for use as a validated system?  This will eliminate 90% or more of the options out there on the web sites that compare the software packages.  Unfortunately, most of them don’t allow you to filter for validated, or validatable systems.  Also, has it been developed for this use from the ground up, or is there just a package of testing that is applied to a general commercial use system?
  2. How long does it take to get it validated and what do I need to do?  Many systems come with “validation packages” that you can use to validate your new system after it is configured for you.  In many cases, the configuration and validation will take months to customize it to your workflow and get the qualification complete.  Often, you have to do a lot of that work.  With GxPReady! Suite, our patented Flash Validation system and method allows this to be reduced to less than a week if that is a priority.
  3. How much does it cost, and are the costs predictable?  Ok, we are pretty sure you looked at this already.   Costs can escalate dramatically once you get it priced for your particular use.  Many of those features you want may not be included in the advertised price.  Consider some of the following costs:
    • Setup
    • Validation
    • Change control
    • Per user/item/site licenses
    • Data Import
    • Maintenance/Backups
    • New revisions
    • Features that you don’t need
  4. What is the feature set, and which features do I need to be part of the validated package?  This is a little tricky.  Some advertised features seem like cool items, but are not required by cGMPs and may impede your qualified use of the system, or may make it tougher to keep up to date.  Do you want to have to enter all the data from each calibration?  Can you justify the automatic changes to calibration and/or maintenance intervals?  Can you print out electronic forms in a “human readable” version, or are they spread over a bunch of screens?   Do you need high customization to do the same thing that other companies can do for a lower cost with the same workflow that is common in industry?
  5. Is the backup there if I get audited?  This is key because companies that use validated CMMS systems typically do it because they need to meet regulatory requirements.  In that case, you need to be able to show traceability between your company requirements and the qualification of the software.  That is to say, it doesn’t matter if this software works for others, but does it meet your written requirements and is it installed in a manner consistent with its intended use?  Can you trace each requirement to some verification that is documented?    Can you do this in a reasonable amount of time in the event of an audit, or do you have to involve the manufacturer of the software and the associated delays?  Documentation and due diligence in selecting a vendor is key to success.

GxPReady! Suite was developed and is maintained to optimize performance against all of these metrics.  It has been developed by people with deep experience in FDA regulated industries to provide a cost-effective solution to the need for a reliable and validated calibration, validation, and maintenance tracking system that you can get up and running in a few days.