The Three Most Important Things About A Validated CMMS system Package

There are many CMMS systems available to choose from, well over 300 at my last check.  You can see some of these here.  You probably don’t have a day to review each one, and you probably don’t have a year to make a decision.  So how do you chose the right one for you?  If you are subject to GMP requirements and you require a validated (or validatable) CMMS system, selecting the right system can be critical to setting you on a  path to compliance.  The following is a short list of items to consider when selecting the best solution for you, given that the best solution is not the same for everyone.

  1.  If you are subject to good manufacturing practices (GMPs), then your CMMS system needs to be 21CFR11/Annex 11 compliant.  That’s a straight-up fact.  That means that changes to the database (e.g. adding and changing records) are tracked and attributable to the person making the change, including the time, date, the reason for the change, identification of the change, and the reason for the change.  This provides an audit trail so it is easy to attribute changes to the person that performed them.
  2. The CMMS you choose to support your GMP operations should be validated.  This means you can create a database; buy and install a validatable system, with all that entails, and install/validate it at your facility; or opt for a validated option.  Note that not every system can be validated, due to many factors, not least of which is the process by which the system was designed and how it was implemented.  The validated system must have documented evidence that the system has been designed and implemented in a manner that supports your intended use, in addition to general GMP and electronic records/signature requirements.
  3. If you clear the regulatory requirements, the ease of use is the next most critical aspect of a CMMS.  Any system is going to make your life easier or more difficult.  How easy is it to implement and get operational?  How much time do you need to spend getting it qualified?  How much time will you spend inputting data?  The worst thing is to have a brand new, validated system and find out that it is just going to make things more difficult.

You probably have noticed that I have not included cost or customer support in the top 3 considerations.  My reason for this is as follows:

  1. Cost is obviously a factor as it may entirely eliminate some options.  However, cost is not a factor in compliance.  The qualification of the software and the actual use of the software do affect compliance.  If you find software that meets your basic requirements, the cost will not be overlooked during the process.  There will be people on your team that will not miss that consideration.  My only tip here is to consider the lifetime cost for the planned period of use and include expenditures related to the qualification of the system, generation of any documentation, and the day to day use and data entry costs.
  2. Customer support is important, but the best form of customer support is good design.  Software that is well designed and easy to use will not require days of training, constant chatting with the supplier and forums and chat rooms dedicated to figuring out how to use the software.

Ultimately the value of validated CMMS software is to provide you a compliant solution to get your calibration, maintenance, and validation completed on schedule.  This helps your company to get its valuable product to the market and reduce the overall workload on everyone in the long view.  For further information about GxPReady!’s solution designed to meet these needs, please contact us.  We would love to give you a demo.