A Quick Solution to Work Request Systems
As a company grows from R&D scale to production scale in FDA regulated industries, there is a transition to increased compliance as manual systems tend to be replaced by automated systems and, eventually, validated automated systems which comply with 21CFR11 and other applicable regulatory guidance.
Throughout this process, there is a tension regarding the right time to make the leap from paper records to full-blown integrated validated solutions. This can be daunting due to the expense and commitment associated with fully integrated solutions, and the fact that workflows and system supports may not be in place at the time when the need for a more robust system than a paper or spreadsheet based system is required.
One solution to this is to support your established quality systems with SaaS based systems, a variety of which can be found with limited investment, time delays, and commitment of resources. As an example a workable, and easy to start work order system is discussed here which could dramatically improve the capabilities of organizing internal work requests in a small to mid-sized companies at low or no cost. Although this solution is a non-validated system, if supported by a good quality management system, this can work to improve your efficiencies and gain experience about what features you may want in a validated system, as well as developing workflows that work for you. Once a decision is made that a particular issue may affect GxP operations, the associated information can be documented in a validated CMMS system like GxPReady! Suite, or some other validated system (even a paper based system).
The advantages of this approach are that it is extremely quick and easy to get a basic on-line work order system (or ticketing system) up and running that can really help a small to mid-sized company get their work done without having to wait for a fully validated system to be in place. Of course, a fully validated comprehensive system may be the best long term answer, but we believe that if there are proper controls in place to ensure that GxP related activities are properly documented, a non-validated work order system can be appropriate for use to facilitate operational efficiencies until a fully comprehensive system can be put in place as a company grows.
If you would like more information about how to set up a Spiceworks system to help you process your work requests, please contact us using the contact form.
