Balancing Complexity and Compliance for Validated CMMS Systems

One of the areas to consider in the selection of a validated CMMS system is the balance between complexity and compliance.  This is especially true for small to mid sized companies who’s primary mission is something other than calibration.  For example, a small to mid-sized biotech company has a mission to get products to market, and keeping up with validation, calibration and maintenance is part of that mission, but not the primary goal.   A company like this may not have deep pockets and resources to create a compliant custom coded solution for their validated CMMS system.  A better solution is an off-the-shelf model that can be qualified for GMP use, but there is always the question of how many and which features you need for compliance.  Remember that while features are great, whatever features you use typically need to be qualified and maintained.  So if you are entering data for each calibration record, there is some time commitment and significant validation work associated with that.  The same is true for highly configurable systems as each configuration may have an effect on the qualification of the system.  In a nutshell, this means that highly configurable systems require significant resources to get them to a point where they are usable for GMP applications.

In many cases, the most straightforward solution is easiest to maintain in compliance.  Some configuration is clearly desirable so that you have a CMMS that uses the terminology and can perform the actions that your procedures require, but it is smart to keep the complexity at a point where it doesn’t slow down your operations with unnecessary activities.  This will make sure you are able to keep your CMMS system current and ready inspection at any given time.  It is amazing how much time you can save during the life cycle of a product by paring down the user requirements for the system to what you really need.  It saves time in development, deployment, qualification, and lifetime use.  Consider the lifetime costs of the features versus the benefits over the product lifetime.  In our experience, this can lead you toward a system that will make compliance much easier to achieve and maintain at a fraction of the cost of an overly complex system.  One size does not fit all for validated CMMS systems.