The Best CMMS Software for FDA Regulated Companies

Wow! There are a TON of CMMS software companies out there! But if you are in an FDA regulated company (e.g. pharma, biotech, medical device, etc) then your choices are MUCH more limited.

If you go to a site to look for ratings on the various CMMS systems, you will invariably see quite a number of systems, but there often is no way to differentiate the non-compliant systems from what you really need from the perspective of an FDA or EMA regulated company. In this case, you need a system that can be validated and is compliant with 21CFR11 (FDA) and/or Annex 11 (EMA).

It is not a trivial matter to “upgrade” a non-compliant system to meet stringent FDA requirements, so it is critical to get started with the right kind of system that has appropriate qualification documentation, design controls, and ongoing support in place intended use in regulated environments. This article is intended to help you narrow down to some of the top available products in the industry and greatly shorten your search time. Note that the systems are not presented in any particular order. (Full disclosure: the author has an interest in GxPReady! and has been involved in it’s development as a validated and validatable CMMS software product. Therefore additional information is provided about this product).

• GxPReady! Suite – This is a SaaS based system that is designed for easy traceability to your requirements, quick implementation, and minimal resources required for use. With a quick startup time and low cost structure, it is a great option for small to mid-sized businesses, or large businesses with sub-organizations that may operate as autonomous or semi-autonomous units. This software is also modular, so you can select to include Maintenance, Calibration, and/or Validation tracking.
• Qualer – A SaaS based CMMS intended for GMP use.
• Blue Mountain – A standard asset management solution that supports GMP use.
• Maximo – A large, integrated enterprise management solution that is used by many large companies.

The reader is encouraged to research each of these for their applicability to the reader’s circumstance. Each has advantages and disadvantages depending on the size, stage, and needs of the company.