Pharmaceutical

Pharmaceutical Industry Insights:
The Pharmaceutical industry is subject to a number of regulations aimed at improving the regulation and the approval process of medications. The two major standards in the pharmaceutical industry are “Computer System Validation” (CSV) and “21 CFR Part 11”. To comply with these regulations, Pharmaceutical companies need structure to ensure that system and software designs meet both business and regulatory requirements to ensure that they are implemented and function as designed.

Computer System Validation (CSV) is a FDA requirement for proving that a system that touches product does what it is designed to do.  These are called “GxP” systems, or Good Practices.  The three practices followed are Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Good Clinical Practices (GCPs).  GxPs govern the systems that are used in these respective areas, and are based on a very stringent SDLC, with strict adherence to document development, review and approval.  CSV is all about quality, safety, and data supporting patient safety.

21 CFR Part 11 refers to the requirements for using electronic records and electronic signatures (ER/ES, or Part 11). Part 11 defines the criteria under which electronic records and electronic signatures are considered to be reliable, trustworthy, and equivalent to paper records. There are very strict requirements for systems that are used to capture ER/ES that go beyond CSV.  Many companies don’t fully implement ER/ES because the cost of implementing and maintaining a compliant environment is too costly.

CMI’s Pharmaceutical Industry Solutions:
CMI’s Practice Framework delivers practices to fully satisfy the configuration management requirements of CSV and 21 CFR Part 11. Our goal is to make the SDLC process as fast and efficient as possible by leveraging automation and controls to accelerate your development cycle.

Learn more about our solutions for your industry.

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