Michael Funk is owner of GMF Consulting Services, LLC. He has over 20 years of science and quality experience in the medical scientific research and pharmaceutical industries. He has extensive experience in the areas of computer validation, software quality assurance, and systems implementation and decommissioning in GxP (GLP, GCP, and GMP) regulated environments (including 21 CFR Part 11 requirements). He specializes in understanding of the software development life cycle (SDLC) and its application within a scalable, business-focused, risk-based approach to systems validation and implementation.
When a GxP computer system is implemented, a wide array of critical elements must be addressed in accordance with regulations for successful and compliant implementation in support of business needs. Recorded
Participants of this webinar will receive valuable insights and tools to be used in the successful creation of a robust Requirements document. Information presented will include topics to be addressed when creating a User Requirements. Additionally, tool Recorded