# 090 - Software Validation, Automation, No-Code Quality Tools and QMS with Harsh Thakkar

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-06-21
- Length: 44m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-21-090-software-validation-automation-no-code-quality-tools-and-qms-with-harsh-thak
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/090---Software-Validation--Automation--No-Code-Quality-Tools-and-QMS-with-Harsh-Thakkar-e25tti9

## Summary

Harsh Thakkar, CEO of Qualtivate, explains how life sciences companies can automate quality management systems (QMS) using no-code tools like Zapier and Make to reduce manual reporting burdens. He details the regulatory framework for software validation, distinguishing between out-of-the-box, configured, and custom software categories defined in GAMP 5. Thakkar emphasizes that validation should focus on intended use and risk rather than validating the entire system, citing the FDA's Computer Software Assurance (CSA) guidance as a way to reduce documentation burdens.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-21-090-software-validation-automation-no-code-quality-tools-and-qms-with-harsh-thak#t=0) Introduction: Harsh Thakkar and Qualtivate
- [4:02](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-21-090-software-validation-automation-no-code-quality-tools-and-qms-with-harsh-thak#t=242) Thakkar's Career: Pfizer, Dr. Reddy's, and Consulting
- [8:31](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-21-090-software-validation-automation-no-code-quality-tools-and-qms-with-harsh-thak#t=511) Automating QMS with No-Code Tools like Zapier and Make
- [18:49](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-21-090-software-validation-automation-no-code-quality-tools-and-qms-with-harsh-thak#t=1129) Software Validation and GXP Assessments
- [25:49](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-21-090-software-validation-automation-no-code-quality-tools-and-qms-with-harsh-thak#t=1549) GAMP 5 Categories: Out-of-the-Box, Configured, and Custom
- [38:13](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-21-090-software-validation-automation-no-code-quality-tools-and-qms-with-harsh-thak#t=2293) Validation Burdens and FDA CSA Guidance
- [41:04](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-21-090-software-validation-automation-no-code-quality-tools-and-qms-with-harsh-thak#t=2464) Naval Ravikant's Almanac and Founder Wellbeing

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Founder wellbeing](https://hardwarepodcasts.com/topic/founder-wellbeing)

## Most relevant to

early-stage companies

## Mentioned

- Qualtivate (company)
- Pfizer (company)
- Dr. Reddy's (company)
- Takeda (company)
- Biogen (company)
- Johnson & Johnson (company)
- Mayonex (company)
- Zapier (tool)
- Make (tool)
- Tableau (tool)
- Accio (tool)
- Obviously AI (tool)
- Salesforce (product)
- GAMP 5 (other)
- FDA (other)
- Naval Ravikant (other)

## Related episodes from other shows

- [#326 CSA vs. CSV: Modern Validation for Modern MedTech](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-07-326-csa-vs-csv-modern-validation-for-modern-medtech) (Global Medical Device Podcast)
- [Common QMS Mistakes SaMD Companies Make](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-21-common-qms-mistakes-samd-companies-make) (Global Medical Device Podcast)
- [#360: Is It Possible to "Buy" a QMS?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-11-360-is-it-possible-to-buy-a-qms) (Global Medical Device Podcast)
- [#329 The Right Way to Start a QMS: When, How, & What](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-27-329-the-right-way-to-start-a-qms-when-how-what) (Global Medical Device Podcast)
- [Implementing an eQMS after Switching from Paper](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-02-implementing-an-eqms-after-switching-from-paper) (Global Medical Device Podcast)

## Citing this page

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