This blog provides a list of medical device validation resources and explains how to create your own resource list.
The first step to understanding how to conduct successful validations are always to read and re-read the requirements of the documents below:
- 21 CFR 820.30(g)
- 21 CFR 820.75
- ISO 13485, Clause 7.3
- ISO 13485, Clause 7.5.2
Unfortunately, we sometimes need to consult a reference guide that explains aspects of the requirements.
Max Sherman (http://bit.ly/MaxSherman) is finishing a new handbook on design and process validation that will be published through RAPS. The following is a list of resources for process and design validation that I am submitting for publication in the book. Many of these resources are free, and these are the resources I personally use to learn and teach principles of validation.
- GHTF/SG3/N99-10:2004 – Process Validation Guidance (http://bit.ly/N99-10)
- ISO 14969 – ISO Guidance document for ISO 13485 (http://bit.ly/iso14969)
- 13485 Plus – CSA Guidance document for ISO 13485 (http://bit.ly/13485Plus)
- AAMI The Quality System Compendium: Bundled Set of Textbook & CD (http://bit.ly/AAMI-Store)
- Preamble to the QSR (http://bit.ly/QSR-preamble)
- ICH Q2: Validation of Analytical Procedures: Text and Methodology (http://bit.ly/Q2-Analytical-Validation)
- FDA Guidance for Part 11: Electronic Records (http://bit.ly/Part11Guidance)
- FDA Guidance for Software Validation (http://bit.ly/FDA-Software-Validation)
- FAQs about Implementation of IEC 62304:2006 (http://bit.ly/Team-NB-IEC62304)
In addition to these resources, you may also need additional resources for design validation. Here are some examples of design validation resources I use in my design controls training “tool kit:”
As a regulatory affairs professional, it is critical to maintain a list of the most current standards and an organized list of links to those standards. I used to keep a list of favorites in my web browser for this purpose, but my database now exceeds the utility of “favorites.” Now, I use my own webpage for this purpose. You can do this yourself by creating a free WordPress blog, and having one of the webpages to the blog be specifically for the purpose of maintaining a list of Standards that are applicable. Here’s a link to my own webpage that I share: http://bit.ly/RA-Resources