For a variety of reasons, software verification and validation has proven to be one of the more challenging and nebulous areas of compliance for companies regulated by FDA. Software, and how it is ...
In pharmaceutical manufacturing, software validation is innovation’s silent killer. A single user requirements specification (URS) takes weeks. Test plans stretch for months. Change controls bog down ...
The U.S. Nuclear Regulatory Commission (NRC) issues initial licenses for commercial nuclear power plants for 40 years of operation – a period originally based on economic and antitrust considerations, ...
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