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# Comments on Electronic Systems Q&A Draft
- URL: https://www.fdaweb.com/comments-on-electronic-systems-q-a-draft/
- Published: 2023-05-16T12:00:00.000Z
- Updated: 2026-09-14T18:32:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154466

Pharmaceutical Research and Manufacturers of America says it appreciates FDA providing the updated guidance and recognizing the “advances in technology” that require additional recommendations. “In general,” it [says](https://www.regulations.gov/comment/FDA-2017-D-1105-0073?ref=fdaweb.com), “we believe the draft guidance provides useful information to sponsors and other regulated entities regarding FDA’s electronic signatures to be trustworthy, reliable, and generally equivalent to paper records. However, we do believe the guidance would benefit from certain clarifications or edits to minimize the burden on the agency and regulated entities while maintaining a high level of trustworthiness and reliability of the electronic systems, records, and signatures.”

The Association of Clinical Research Organizations provides line-by-line specific [comments](https://www.regulations.gov/comment/FDA-2017-D-1105-0071?ref=fdaweb.com) on an FDA draft guidance with questions and answers on electronic systems, records, and signatures in clinical investigation to help “refine the final guidance to reflect the current industry usage of e-systems and e-records.”

In its [response](https://www.regulations.gov/comment/FDA-2017-D-1105-0070?ref=fdaweb.com), the Critical Path Institute thanked and commended FDA for inviting public comments as part of the creation of a guidance document for using electronic systems, records, and signatures in clinical investigations. It included responses from individual consortia and programs and their respective stakeholders.

Amazon Web Services [said](https://www.regulations.gov/comment/FDA-2017-D-1105-0065?ref=fdaweb.com) it appreciates and strongly supports FDA’s inclusion of cloud services as eligible technologies to support sponsor compliance with the Good Clinical Practice guidelines and other recordkeeping requirements. It calls on the agency to take a broader approach to accelerate adoption of innovative technologies that can improve product quality, facilitate innovation, and reduce burden in meeting regulatory requirements. It calls on FDA to issue guidance to enhance the use of cloud-based technologies throughout the product lifecycle, including explicit examples of ways cloud services can help manufacturers meet regulatory requirements.

Finally, Boehringer Ingelheim [provided](https://www.regulations.gov/comment/FDA-2017-D-1105-0064?ref=fdaweb.com) line-by-line specific comments.