DA's regulation 21 CFR Part 11 onw...

DA's regulation 21 CFR Part 11 onward Electronic Records and Electronic Signatures provides industry with the requirements that allow electronic records and signatures in computerized schemes in place of paper records and handwritten signatures. (1)
Since the introduction of the final behavior in 1997, however, its implementation has been relatively slow--mainly befitting to questions surrounding the intent and interpretation of these regulations, the high charges anticipated by industry, and the absence of acceptable and commercially available technical solutions. The following case application of mind ...