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by Alan Alper, MA Editorial Staff Posted on Friday, July 29, 2005 1:00:00 PM   | Abstract: | Here are some tips and resources for keeping pace with evolving FDA requirements |
On the books since the late 1990s, Title 21, Code of Federal Regulations, Part 11 (21 CFR Part 11) established criteria under which electronic records and signatures are now considered equivalent to paper records and handwritten signatures in validating manufacturing processes regulated by the Federal Drug Administration (FDA). But the regulation, which was vigorously policed by the FDA initially to ensure that process manufacturers using e-signatures can document "good" manufacturing processes (i.e., safe ingredients, as well as proper assembly, packaging and handling procedures) is for the most part now left to the industry to self administer, analysts say. The requirement for e-signatures, archiving and record retention in 21 CFR Part 11 was an outgrowth of the FDA's Good Manufacturing Practices (cGMP regulations). But as political winds in Washington, D.C have shifted, the FDA is using Part 11 compliance to help propel business process enhancements that result in improved manufacturing productivity. The FDA's focus is to ensure that manufacturers are in control of their operations, making them more accountable to enforce the cGPM regulations, which in the past have resulted in heavy fines levied through consent decrees (see what "http://www.managingautomation.com/maonline/magazine/read/3522" target="_blank"> non-compliance cost Abbott Laboratories and Schering-Plough a few years ago). [Click to continue] |