When assessing operations (calibration, validation, and/or maintenance) management software, especially for GxP applications, compliance is an important, but not the only important endpoint. Meeting GMP, GCPor GLP requirements (including 21CFR11) for your validated calibration management softwareis the baseline requirement.
Aside from the compliance aspects, there can be major impacts of your choice for validated software. These can include extensive additional costs and time delays getting the software qualified, incorporating historical calibration data, and a high likelihood of additional expenses supporting the calibration management software you choose to install.
Experience has shown that the usability and workflow design for the software can affect compliance and the efficiency of your department. There are always tradeoffs in determining which software to purchase and the attendant benefits. Some management systems require extensive data entry, thereby tying up your important resources for marginal, if any, compliance benefit.
Software systems that are extremely flexible are also often difficult to configure and validate, especially if thesoftware affects several departments.Thiscan result in a system that can do”anything”, but not do the specific tasks you require particularly well. Even after all of the time has been spent configuring and validating, you may end up with a system that is locked into change control, yetrequiressignificant modifications to your workflow to keep itrunning. Additionally, there is a reluctance tochange anythingdue to the fear of opening that “can of worms”of making the change and re-testing to maintain qualification.
One way of getting around this problem is by designing your own software. If you know exactly what you need and have a design team, with the money and time, this can be an option. However, it is important to understand that many developers are not familiar with the area of application (e.g. calibration, maintenance, validation) or GxP requirements, and the design meetings as the delivery deadline approaches can become, shall we say “vigorous”.
At GxPReady, we put our expertise to work up front in designing operations management system workflows based on GxP operational experience and human factor expertise (the same expertise that is used helping fighter pilots understand the information presented to them in the cockpit). This helps you meet your compliance requirements, while streamlining your workflow instead of adding to it. We have managed calibration labs, validation departments, and maintenance operations at FDA regulated companies and have experienced pre-approval inspections.
It is not often that the least expensive option is also the best, and the easiest to implement. GxPReady can help you get compliant in a flash withour GxPReady! Suite software. Let us show you how easy it can be.