Current-state compliance relies on 100% document-by-document approval, with little or no provision for modular or family-based acceptance. The desired-state alternative is summarized here courtesy of Genentech’s Ron Branning, a major advocate of standardization as a prerequisite of Self-Evident Engineering (SEE).
“Developing and applying agreed industry standards for specification and validation would:
- Yield reliable, self-validating outputs at each stage of the development process
- Eliminate redundancy in testing and documentation
- Eliminate ambiguity in specifications
- Eliminate gaps and overlaps in departmental roles and responsibilities
- Allow regulatory/quality to audit the standards rather than individual tests
- Save companies time and resources
- Adapt readily to innovation.”
I look forward to your feedback re the above, particularly in regard to the opportunities/implications associated with item 5.
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