Should a Work Request System be Validated?

validated work order system

Work performed on GxP systems should be appropriately documented.

A work request (or work order) system, in the context here, is a system that allows employees of a company to request support from engineering, calibration, maintenance, and possibly, validation.  The typical workflow for a work request is that the user submits a request, a unique number is assigned, the work is approved, and then completed.  The user, as well as the resources that perform the tasks  need access to the system.  For GxP applications, quality assurance also needs to have input into the process if changes may affect the GxP readiness of any system.

Some companies purchase a validated work request system and process all work requests (GxP and non-GxP) through that system, as a conservative approach to ensure all requests are properly evaluated.   This can be expensive and burdensome.  In addition, with a mixed use system, the quality of the information within the system varies from record to record (non-GxP and GxP record submitters), since the training of the users can also vary.  As a result, a person reviewing the various records may see everything from changing a light bulb or fixing a bathroom leak to replacing a HEPA filter in a cleanroom or request for equipment calibration.

At GxPReady!, we have taken the approach that, especially for small to mid-sized companies, it is a better practice not to mix non-GxP related changes in the validated system  and that a work request system itself functions better when it is a company wide system.  We support the idea (especially for small to mid-sized companies) that you can initiate all work requests in the business system you may already be using for other purposes and procedurally ensure that work on GxP systems is appropriately controlled.  If a work request is submitted that does have GxP ramifications, it can be identified within the system before work is performed and can then be documented in your validated Computerized Maintenance Management System (CMMS).  This approach has several advantages:

  1. Any work request system can be used that is convenient for the business.  For example, the system used for IT tickets may be able to be expanded for general use.
  2. Non-validated work request systems allow greater flexibility and much lower cost than validated systems.  There are many available at no or low cost.
  3. Changes in workflow can be made to the work request system as desired without being tied up by change control.
  4. Employees that submit work requests do not need to learn two work request systems with multiple username and password combinations (one for GMP and one for business systems).
  5. Work that is actually performed can easily be documented in the validated CMMS system when the documentation is completed without the inclusion of various non-relevant discussions that may distract from the relevant facts of the change or service.
  6. Fewer users need to be defined in the validated CMMS system (which can save $$ in some pricing models).
  7. Non-GxP documentation does not clutter your validated systems.
  8. In the event of an audit, it is easy to demonstrate compliance by accessing the relevant documentation in the validated CMMS system.
  9. This is consistent with the idea of impact driven effort that is central to management of GxP activities.

Our recommendation for small to mid-sized companies that have GxP requirements is that they develop clear, written procedures to evaluate and determine when work requests become GxP changes that need to be controlled.  Then they can use their existing work request ticketing system to process work requests to the point where it is determined (based on the company SOPs) that the work may affect a GxP system. At that point they generate the appropriate documentation which can be included in the validated CMMS system for tracking the GxP work.  In this way, you can focus your efforts and expenditures on the important tasks related to compliance, while freeing up the work request system to meet the requirements of your company-wide users.

GxPReady! has generated guidelines for setting up some popular ticketing systems that can function as a work request system at no or low cost.  These will be available soon.  Please contact us using the contact form for additional information.