Beyond Reasonable Doubt
In 1999 the Food and Drug Administration (FDA) in the USA mandated a Code of Federal Regulations; Electronic Records and Electronic Signatures (21 CFR Part 11). This lead to the Pharmaceutical industry collaboration known as SAFE-
All the members each have a vested interest in protecting their highly valuable research in Life Sciences, New Drug Development and highly sensitive clinical trials data. The capital investment commitments (knowledge and financial) made by Pharmaceutical companies is in the 10’s of millions of dollars / pounds annually and often stretches to 10 years and more as they seek FDA approval to bring a new drug to market and accrue a return on investment. In 2004, the Pharmaceutical Research and Manufacturers of American (PhRMA) reported that approximately 40% of all Research and Development costs are attributed to paper based business processes ($9 Billion in the U.S. alone).
In addition to ‘keeping the wrong people out’ of sensitive information repositories, the introduction of the FDA’s Electronic Submissions Gateway (ESG) and the SAFE-
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