Experiences with Oracle Apps and FDA Regulations

Jan 17, 2007 / By Sylvain Fontaine

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For several years, I worked as an Oracle Consulting employee, and I’d like to share my experience in that role, working on a massive Oracle Applications implementation deployed in an FDA-regulated company.

The project was a very large implementation involving the deployment of the whole Oracle E-Business Suite, Release 11.5.9. Several product families were to be deployed, so the rollout of the different product families was conducted in phases. My team and I were deploying Financials, HR, Procurement, Order Management, Manufacturing, Supply Chain Planning (along with Oracle Express), and Intelligence (Financial Analyzer). Okay, it was a colossal Apps implementation.

During the planning and deployment process, we always followed “best practices” to ensure the best possible success while remaining supported by Oracle. The greater challenge was to do the install and deployment while being compliant with the FDA regulations.

The two most important aspects of doing the deployment according to FDA regulations were, first, to always ensure proper and precise documentation, and second, to always get the documents signed-off by several different managers, each representing their own departments — the technical team, the functional testing team, the IT director, and the QA manager. As a consequence of this process, the pace at which the deployment and changes were rolled out was much more deliberate than in a non-regulated environment.

I had always provided thorough documentation in previous projects, and that helped me a lot in an FDA-regulated environment where that is paramount. Nonetheless, I must admit that I found it challenging having to put together all the required documentation and obtain all the signatures necessary before making any changes to the production system. This requirement made it essential that our documents described our plans very accurately — an excellent thing, as I’ve seen too many projects where extremely poor or absent documentation caused all kinds of problems.

Beyond the experience I gained with the regulations themselves, the rigors of deploying Oracle Apps in an FDA-regulated environment made me much more attentive to the importance of properly documenting the work to be done. I wish everyone the same realization.

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