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# 2 Comments on Computer Software Assurance Guidance
- URL: https://www.fdaweb.com/2-comments-on-computer-software-assurance-guidance/
- Published: 2022-11-10T12:00:00.000Z
- Updated: 2026-09-14T18:05:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153179

Bristol Myers Squibb commends FDA for publishing a draft guidance on computer software assurance for production and quality system software, but finds several aspects of it that appear contrary to the agency’s stated objectives or are not fully developed. In a comment [letter](https://www.regulations.gov/comment/FDA-2022-D-0795-0079?ref=fdaweb.com), BMS says the items needing clarification are:

- separate guidances should be developed for product software (medical devices) and non-product software;
- inclusion of examples across the spectrum of product lifecycle management to understand the levels of risk across the lifecycle of a product and how the assurance approach can vary at different product development stages;
- additional guidance on how the assurance (testing) approach for features will be tied into the overall validation strategy based on the intended use;
- consider technological risks as part of a risk-based approach; and
- change references to test plans to Test Protocols and Test scripts for unscripted and scripted testing approaches.

In its [comment](https://www.regulations.gov/comment/FDA-2022-D-0795-0082?ref=fdaweb.com), the International Society for Pharmaceutical Engineering says it is pleased that the guidance focuses industry computerized systems management effort on quality using a risk-based approach framework for computer software assurance throughout the software’s lifecycle. The society says its members “support the premise that software development tools, including test tools, should not be validated; rather that there should be evidence that they are properly installed, configured, and controlled.”