Does My Vendor CMMS System Clear the Bar for GMP Use?

Does my contract calibration company's database fulfill my FDA requirements?

Databases and scheduling systems provided by your vendor may be handy, but they don't meet FDA requirements for a validated system.

As a growing company, you may be outsourcing a significant amount of calibration, maintenance, and validation to contract providers.  In some cases, this means they will provide you access to their database, at no cost, to help you track your equipment.  This is great!  A free CMMS and asset management system.  Now you don’t need to get your own and deal with all of the hassles of installing the hardware and software, performing the qualification, etc.  They handle it all for free.  Case closed, on to the next fire you have to put out!

A vendor’s database is convenient, but I don’t know of any such system that is compliant with GMP requirements or allows the flexibility for use with multiple vendors.  These systems should be for “reference use” only.

This is tempting, and for non-GMP facilities, using the vendor database may be a reasonable option.  However, for GxP compliant companies, this has several drawbacks:

  1. As of this date, these systems are NOT validated, and they do not meet the stringent requirements for GMP or 21CFR11 compliance.
  2. Most of these systems are multi-tenant databases, so if the database were to crash for one tenant, the others are at risk.
  3. As a customer, you don’t have any control over the revision process or operational changes to the software that could affect your ability to meet your internal requirements.
  4. There is no validation or turnover package that is provided for your records.
  5. If you use multiple vendors, then there are multiple databases you need to keep track of, so you would need to develop procedures for each one.
  6. Even if you could manage the compliance side of things, you are thereafter dependent on the provider for all those services and should you chose to change your calibration provider, it would be very cumbersome to switch.  Good for your provider.  Maybe not good for your convenience.

Once you realize this, the next thing is to look into options for other CMMS systems and asset management systems, of which there many, a few of which are designed to be validated to meet GxP requirements.  The field of available product narrows quickly once you determine that you need a validated system.  Depending on the balance of your needs and your budget, you may find a system like GxPReady Suite will suit your needs as a small to mid-sized company that runs lean and doesn’t have a ton of money to throw around but needs to meet FDA requirements efficiently and in a manner that doesn’t require a huge investment in financial, qualification, or data entry resources.  Much larger companies may benefit from products like IBM Maximo, which requires much more investment and is resource intensive but provides flexibility that very large companies may require.

This isn’t to say you should never use vendor databases, as they may prove to be a good backup, or a method for your vendor to remember to contact you for convenience.  But they should not be considered your primary database in a GMP application.