# #326 CSA vs. CSV: Modern Validation for Modern MedTech

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-07-07
- Length: 1h 08m
- Episode: 326
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-07-326-csa-vs-csv-modern-validation-for-modern-medtech
- Listen: https://podcast.greenlight.guru/episode/326-csa-vs-csv-modern-validation-for-modern-tech

## Summary

Sandra Rodriguez, an analyst at Axendia, discusses the FDA's shift from Computer System Validation (CSV) to Computer Software Assurance (CSA) in medical device manufacturing. She explains how CSA flips the traditional validation pyramid by prioritizing critical thinking and risk assessment over exhaustive documentation, significantly reducing the burden on companies. The conversation covers the industry's response to the September 2022 draft guidance, the role of GAMP 5, and the evolving relationship between life science companies and technology vendors like Greenlight Guru.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-07-326-csa-vs-csv-modern-validation-for-modern-medtech#t=0) Introduction and Guest Background
- [6:46](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-07-326-csa-vs-csv-modern-validation-for-modern-medtech#t=406) The History and Cost of Traditional CSV
- [11:45](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-07-326-csa-vs-csv-modern-validation-for-modern-medtech#t=705) Defining CSA and the New Pyramid Model
- [18:51](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-07-326-csa-vs-csv-modern-validation-for-modern-medtech#t=1131) Scope of CSA: Non-Product Software
- [22:58](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-07-326-csa-vs-csv-modern-validation-for-modern-medtech#t=1378) Practical Implementation and Risk Assessment
- [26:05](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-07-326-csa-vs-csv-modern-validation-for-modern-medtech#t=1565) Industry Feedback and Future Guidance
- [39:51](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-07-326-csa-vs-csv-modern-validation-for-modern-medtech#t=2391) Cultural Shifts and Vendor Relationships
- [52:56](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-07-326-csa-vs-csv-modern-validation-for-modern-medtech#t=3176) Q&A: Terminology, GAMP 5, and Cybersecurity

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)

## Most relevant to

established companies

## Mentioned

- Axendia (company)
- Greenlight Guru (company)
- FDA (company)
- Boston Scientific (company)
- Edwards Life Sciences (company)
- Baxter (company)
- GAMP 5 (other)
- MDIC (company)
- Case for Quality (other)
- ISO 13485 (other)
- ISO 14971 (other)
- 21 CFR Part 11 (other)

## Related episodes from other shows

- [090 - Software Validation, Automation, No-Code Quality Tools and QMS with Harsh Thakkar](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-21-090-software-validation-automation-no-code-quality-tools-and-qms-with-harsh-thak) (Let's Combinate)
- [How to Speed Up Safety Critical Processes](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-07-27-how-to-speed-up-safety-critical-processes) (The Pragmatic Embedded Podcast)
- [010 - "Don't Make Assumptions" with David Simoens](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-08-010-dont-make-assumptions-with-david-simoens) (Let's Combinate)
- [134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-01-134-iso62304-software-development-process-samd-closed-loop-systems-complexities) (Let's Combinate)
- [128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-20-128-former-fda-inspector-and-managing-consultant-vin-cafiso-cadavers-autopsies-t) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-07-326-csa-vs-csv-modern-validation-for-modern-medtech. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.