# Geetu Abbi on When to Build a Digital Quality Function

Page: https://stenobird.com/podcast/let-s-talk-quality-6567110/geetu-abbi-on-when-to-build-a-digital-quality-function
Text version: https://stenobird.com/podcast/let-s-talk-quality-6567110/geetu-abbi-on-when-to-build-a-digital-quality-function.md
Podcast: [Let's Talk Quality](https://stenobird.com/podcast/let-s-talk-quality-6567110)
Published: 2026-09-22T11:45:00+00:00
Episode link: https://rx-group.io/captivate-podcast/geetu-abbi-on-when-to-build-a-digital-quality-function
Audio file: https://episodes.captivate.fm/episode/4016a89c-df6d-43f8-9297-b4f0cfe67768.mp3
Processing state: not_requested
JSON: https://stenobird.com/v1/public/podcasts/let-s-talk-quality-6567110/episodes/geetu-abbi-on-when-to-build-a-digital-quality-function
Duration seconds: 2472

## Resource

Geetu Abbi was handed the GAMP guide as a new validation engineer at Genzyme, and in 2024 she co-led one. Geetu Abbi on When to Build a Digital Quality Function In today's episode I was joined by Geetu Abbi, Head of Digital Quality Assurance at Alkermes. I wanted to speak to Geetu because Digital Quality was not a job title eight to ten years ago, and she has grown into the role from computer systems validation. She moved from software testing into validation at Siemens without a life sciences background, and in 2024 she co-led the GAMP guide for GCP and clinical trials. We talk about: - Moving from software testing into validation at Siemens, with no prior exposure to Part 11 or 21 CFR 820 - What Digital Quality is, and the gap it fills between site Quality and clinical Quality - Data lifecycle mapping, and why validation now has to be revisited with every change - Delivering seven validated systems in eight months to support the Alkermes-Mural Oncology separation in 2023 - Her advice to the next generation of Quality professionals on why they don't have to solve everything alone Thank you Geetu for sharing your journey. Timestamps: (00:00) Introduction and guest background (03:42) From QA to validation (08:00) Career turning point (13:04) What digital quality means (22:28) Digital quality as a career opportunity (29:58) How the team is structured (34:06) Advice for future quality leaders

## Actions

- request_transcript: `POST https://stenobird.com/v1/public/podcasts/let-s-talk-quality-6567110/episodes/geetu-abbi-on-when-to-build-a-digital-quality-function/transcription-requests` — Idempotently request low-priority transcript generation for this episode.
- read_markdown: `GET https://stenobird.com/podcast/let-s-talk-quality-6567110/geetu-abbi-on-when-to-build-a-digital-quality-function.md` — Read the agent-friendly Markdown representation of this episode resource.

A page view does not enqueue transcription. Agents should invoke `request_transcript` explicitly when they need this episode processed.

## Transcript

Full transcripts are not published on public pages unless there is a clear rights basis.