09. Software Supplier’s Role in Validation

09. Software Supplier’s Role in Validation

…auditors must look closely to determine whether the supplier does have a controlled Agile SDLC documented for its product or whether the supplier is just using the term Agile to mask an ad hoc, chaotic, and uncontrolled programming effort. (213) Writing software for regulated environments should be a creative discipline and not a creative art…

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