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