Product development has become an increasingly critical factor in highly-regulated life sciences industries. Biotechnology, medical device, and pharmaceutical companies all rely heavily on validated and traceable product development systems, especially for high risk and complex products. For companies that choose to develop their own management and control of development assets are still subject to provisions of 21 CFR Part 11 from the Food and Drug Administration (FDA), which require extensive validation efforts and internal support costs. Streamlining processes and automating hand-offs during development and testing is not a trivial task, even with a document or quality control system.
FDA ruling 21 CFR Part 11 specifies how electronic records and electronic signatures can be used as a substitute for paper records and handwritten signatures. It is broadly applicable to electronic records that are central to the process of developing and manufacturing biotechnology, drugs, and medical devices. The goal of this paper is to educate product developers so they can understand the impact of this ruling and learn how to achieve compliance through the intelligent use of tools and good process.