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21 CFR PART 11

Software has become an increasingly critical factor in highly-regulated life sciences industries. The pharmaceutical, medical device, and biotechnology industries all rely heavily on validated software and software development systems. For those solutions that cannot be purchased off-the-shelf, many companies have developed custom software that closely meshes with their internal business and manufacturing processes. While this may result in significant cost savings by streamlining complex operations, it can also subject developers to the provisions of ruling 21 CFR Part 11 from the Food and Drug Administration (FDA). 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, including software, that are central to the process of developing and manufacturing drugs and medical devices, and research and biotechnology.