• John D. Hannan

FDA Validation on a Microsoft Dynamics 365 Life Sciences Project - Impact of IQs, OQs, and PQs

Leading ongoing and having completed several Microsoft Dynamics 365 (or previous "AX" version) projects in a FDA Validated state for Life Sciences companies, I am fully aware of the impact that the Validation process has on the overall ERP implementation project. The most basic reason for this is that the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualifications (PQ) must be done in lock-step with the ERP implementation.

The first action to be taken when approaching a Life Sciences ERP implementation is to determine if the ERP will be supporting processes that fall within FDA Good Practices (GxP) guidelines, the most prevalent being Good Manufacturing Practices (GMP). This must be determined well before the implementation begins as there will be impacts to project timeline and budget because of the need to incorporate the Validation processes within the project plan. Let's break down each of the Qualifications by impact on a Pharmaceutical, Biotechnology or Medical Device company's implementation:

  • Install Qualification (IQ) - The easiest of the three qualifications given that Microsoft Dynamics 365 is a Software-as-a-Service (SaaS) cloud solution. Nonetheless, the purpose of the IQ -that the software is installed according to manufacturer's specifications and a protocol for the production established - remains. Planning for time and resources to accomplish this both during the original install of the test environments, but also, and more important for planning, during the provisioning of the production environment before go-live. Note especially that even if the project is a phased approach with non-GxP processes, such as finance and non-inventory procurement, being implemented first, this must still be done on the original install.

  • Operational Qualification (OQ) - This qualification has the most profound impact on a Microsoft Dynamics implementation project plan. The development of the performance test scripts is necessary to capture the required information to comply with FDA / GAMP 5 (Good Automatic Manufacturing Practices issue 5) guidance. These test scripts are much more detailed than those usually found in a non-Validated environment. Time to develop these test scripts and approve them must be worked into the project plan. Additionally, the testing process (module and integration) involves documenting that these scripts were followed and the results recorded with signatures. This takes more time that the looser demo-like testing that takes place on some projects.

  • Performance Qualification (PQ) - The PQ should always be performed at the user location in order to provide for a full representation of how everything will work from the end-user perspective. The planning for the resources to be available and the test to be conducted on-site must be incorporated into the project plan. Since the execution of the PQ must be done with company-specific data and testing all hardware and software components, this event must be planned after all of those elements are available.

FDA Validation does add timing and effort to an implementation, but overall it ensures good practices are followed and in addition to being mandatory for compliance, the system will be better off in the end for having completed this. In a future blog, I will discuss the deliverables related to the FDA Validation process.

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