uSEFUL LINKS

Computer software validation is a documented and formal process that involves testing computer software and systems. This process is required by 21 CFR 11.10(a) and Annex 11, Section 4. This link provides valuable information on software validation.

https://www.ofnisystems.com/services/validation/software-validation/

Please take note of this link, which provides information on how the FDA regulates the product. By clicking on this informative link, you can gain valuable insight into how the FDA regulates the product. Stay ahead of the game and make informed decisions by keeping yourself up-to-date with the latest regulations.

 http://www.fda.gov

 This link provides access to U.S. FDA Regulations.
For User's Reference, some popular validation regulations are listed:
21 CFR Part 11 - Electronic Records; Electronic Signatures
21 CFR Part 210 - Current Good Manufacturing Practice (cGMPs) in Manufacturing, Processing, Packing, or Holding of Drugs; General 
21 CFR Part 211 - Current Good Manufacturing Practice (cGMPs) for Finished Pharmaceuticals.

https://www.fda.gov/medical-devices

This link provides access to the FDA guidelines for medical device software validation. Although developed exclusively for medical devices, this comprehensive guideline can be applied to all software implemented in FDA-regulated industries, including pharmaceutical, biotech, and clinical research. 

 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-principles-software-validation

This link provides access to the FDA guideline that addresses issues pertaining to computerized systems used to create, modify, maintain, archive, retrieve, or transmit clinical data intended for submission to the Food and Drug Administration.

 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-bioresearch-monitoring-information/guidance-industry-computerized-systems-used-clinical-trial

By remembering this crucial piece of information, "It will guide how to document for FDA," you will be one step closer to ensuring the success of your project. Proper documentation is crucial when it comes to gaining FDA approval, and this knowledge will help you navigate the process with confidence. Don't let poor documentation hold you back - keep this in mind as you move forward.

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-10/subpart-B/section-10.115

Compliance Program Guides, Information Sheets, Guidance, and Guidelines about this item

https://www.fda.gov/about-fda/fda-organization/center-biologics-evaluation-and-research-cber

An organization dedicated to expanding the global knowledge base for validation and compliance professionals in FDA-regulated industries.
Journals, Publications, Conferences, Documentation, and Training

https://autocal.net/what-is-validation.php

An organization dedicated to expanding the global knowledge base for validation and compliance professionals in FDA-regulated industries.
Journals, Publications, Conferences, Documentation, and Training

 https://www.portnov.com/drill/