The Benefits of a Modular Validated CMMS System

modular is better for validated CMMS systems

Use a modular validated CMMS system supported by off the shelf solutions to simplify your life and lower costs.

When one is faced with the prospect of buying software for regulated applications, there seems always to be a tension between buying an all-inclusive system or going with a piecemeal approach.  Often, the all-inclusive system is more expensive, takes longer to configure, and likely affects users beyond the group of users that are originally requiring the software.  On the other hand, with the piecemeal approach, it may be difficult to integrate the operations of different departments.  A modular approach provides additional options in that functionality can be phased in as necessary.  This is why GxPReady! Suite is designed in a modular fashion, allowing multiple departments to use it, or just a department that requires it.  So, for example, if the Calibration department needs a tracking system, but the Facilities Maintenance department is happy with their own system, the maintenance module can be turned off until it is required.  This works to the benefit of both departments.

For a validated CMMS system, it is clear that the validation ultimately is a significant component of the cost and also tightens down the flexibility, as changes to the system require a rigorous change control.  In the case of SaaS based systems, this is managed by the provider and fairly transparent to the users, as determined by their service contracts.  So the question becomes, out of all of the operations in a company, where should the efforts be focussed?  Of course, those who have done their GMP homework know that you should always focus where it will have the most impact.  We focus on the GMP systems for the validation, and leave the business systems to other quality control programs.  Clearly, Calibration, Validation, and Maintenance  of GMP systems fall under the category of systems that have more impact than your average business systems.  A validated CMMS system, therefore, is pretty locked down under change control and has fixed workflows.  The records entered into these systems have typically been reviewed and approved and are locked away in a safe place.

One might naturally assume that the system from where requests for any work in the company are generated should be an integrated part of this validated system.  Often referred to as a Work Request, Work Order, or Ticketing system, it seems that any information that would result in action performed on a GMP system should be recorded in a validated system.  Of course, even if a Work Order system isn’t validated, the documentation that is generated to record the reasons for any GMP activities and the activities themselves would already be documented in the CMMS system, even without the Work Order system in use.  Often these are documented on Change Control, Deviation, or other such GMP documents that are attached within the CMMS system.

Consider that the vast majority of items in an average company Work Order system are not GMP related, such as office matters, leaks, temperature adjustments, moving furniture, adding electrical outlets etc, and that the minority of items that do impact GMP systems are easily documented outside of the Work Order system GxPReady! Suite has initially been designed to allow users to select any Work Order system they see fit to use.  Additionally, imposing change control on the Work Order system reduces flexibility and the number of options available for use, while increasing cost.  Finally, since the average Work Order system includes mostly non-GMP information entered by a large variety of personnel with varying qualifications, the quality of communication can be variable and non-ideal during an audit of the validated systems.

For small to mid-sized companies, a solution to this problem can be found in the use of an independent Work Order system.  If procedural controls are in place to use the Work Order system as a reference for scheduling work, and GMP related activities are documented and assessed on paper, as they often are anyway, then it is much more cost-effective to operate the Work Order system as a reference only type system that may be used for the convenience of scheduling.  In this way, the users operating the Work Order system are free to optimize it as they see fit, in the spirit of continuous improvement.

In fact, if this approach is used, it is possible to use very inexpensive (or free) systems that are widely available, and secure.  One example is Spiceworks, which is free for any number of users and can be installed either locally or in the cloud.  Using a product such as this, users do not need to have yet another log in, because it can be managed under the existing active directory system.  And they can get to the information they need from virtually anywhere.  This takes about an hour or two to set up.  We have developed a recommended practice that, when used, can provide for the installation and configuration of Spiceworks that can work well for small to mid-sized companies to manage their tickets, while allowing them to document GMP impact data and documentation in the validated systems.  If you are interested in finding out more about how you can use this simple approach for your work orders, please contact us at [email protected].

All that being said, some folks do like to include critical GMP decision information in their Work Order system.  GxPReady! Suite will one day include such a module that will reflect the ease of use and straightforward work flow our customers are used to.  So stay tuned for more information on that front!