The Value of a Validated CMMS System

A validated (or validatable) CMMS system provides an important value to GMP regulated companies.  First and foremost, it allows the company to maintain compliance in their calibration, validation, and maintenance activities.  Core functions of the company including R&D, manufacturing, and general operations depend on having systems run smoothly.  A database such as those provided by Blue Mountain, IBM, or GxPReady can fill a critical gap that other companies which do not support 21CFR11, Annex 11, or general GMPs cannot.

A validated CMMS system gives you the confidence that you are keeping up with your calibration, maintenance, and validation with traceability and convenience not available in spreadsheet programs, or other scheduling systems.

Also, you can have the confidence that the system is under change control so you won’t be surprised with unannounced updates that may change the functionality or that are not properly maintaining traceability of changes to the system or the data within.

Systems that are not designed for GMP or 21CFR11/Annex 11 compliance may not have a formal design management process, very low bug frequency, or other features you need in a system to support your critical GMP operations.  As a result, any validation performed on systems that are not designed for GMP use may have limited benefit because the control that a user has over the system can be quite limited.  A company that is not focused on GMP compliance may update the software regularly and without notification in such a way that the operation is affected and established SOPs may be rendered incorrect.  In a non-regulated environment, the ability to roll out updates frequently may be an advantage, but in the regulatory environment it is not so.

Ultimately, the purpose of the validated CMMS system is to allow the validation, maintenance, and calibration departments in a GMP compliant company to operate efficiently.

A reliable system may be preferred to an very configurable system that is subject to constant changes, especially for small to midsized companies with small to mid-sized budgets and staffs.  This supports the mission of the company, to produce innovative products that meet compliance requirements and get that great new product to market.