Information Technology (IT) systems that are deployed in the Life Science industry may be subjected to FDA regulations, specifically Code of Federal Regulations Part 11 (CFR Part 11). This regulation was established to assure a consistent level of safety during the development of drugs, therapies and devices which are ultimately intended for human use. Failure to adhere to these guidelines could result in severe fines from the FDA, or worse, could endanger the health and lives of patients.
CFR Part 11 is not a prescriptive set of directions, but rather a set of guidelines for the documentation, testing, deployment and maintenance of IT systems; also known as ‘validation’. There are general industry naming conventions and practices for deploying IT systems that are FDA compliant, yet scenarios often arise that require interpretation of the guidelines for a given project. The project manager that has a strong understanding of validation will run a more effective and efficient project!
Hawkins Point partnered with Project Management Institute and Bio Team to host a webinar recently that introduced concepts and terms common with the validation of IT computer systems. You can download the content from that webinar for your own use now!
About our Hosts
With over 20 years experience working as an IT Project Manager in Government, High Tech, Finance, and Life Science industries and overs 10 years of working in Life Sciences as IT Program Manager, Kristen currently specializes in high-performance computing for Scientific Research for The BioTeam.
Ron has 30 years experience in Engineering, Operations, IT, and Consulting across many industries and domains. For the past 10 years, he’s worked in Life Sciences as Project & Program Manager. He currently serves as Vice President of Life Sciences Services for Hawkins Point Partners– a Strategic IT Solutions Provider.