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# Comments on Computer Software Assurance Guidance
- URL: https://www.fdaweb.com/comments-on-computer-software-assurance-guidance/
- Published: 2022-11-15T12:00:00.000Z
- Updated: 2026-09-14T18:06:25.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5153203

Amazon Web Services says it supports the intent of an FDA draft guidance on computer software assurance for production and quality system software and makes several recommendations “to strengthen and accelerate the use of technology for quality improvement.” The company [recommends](https://www.regulations.gov/comment/FDA-2022-D-0795-0090?ref=fdaweb.com):

- reissuing the guidance to apply across the entire agency instead of only medical devices “so that manufacturers of other regulated products have greater assurances on the use of technology to meet compliance requirements”;
- that FDA explicitly reference the role of cloud service providers in supporting compliance and the success of computer software assurance programs;
- updating other FDA policies for consistency with the changes made in this draft; and
- taking a broader agency approach to accelerate the adoption of innovative technologies that can improve product quality, facilitate innovation, and reduce the burden of meeting regulatory requirements.

The Massachusetts Technology Innovation Corp. [says](https://www.regulations.gov/comment/FDA-2022-D-0795-0085?ref=fdaweb.com) the guidance seems to be medical device-centric and says it “would be great to expand the scope (more explicitly) to pharmaceutical and biotech sectors, too.”

Finally, Sanofi [says](https://www.regulations.gov/comment/FDA-2022-D-0795-0087?ref=fdaweb.com) the explicitly narrow definition of the scope of the draft to “systems used as part of medical device production or the quality system may negatively impact the adoption of the principles in a broader scope, especially the pharmaceutical industry.” It recommends adding a statement in the Introduction, Background, or Scope section that the principles described in the guidance apply more broadly to systems supporting GxP (good practice)-regulated processes.