Geetu Abbi on When to Build a Digital Quality Function

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 FunctionIn 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 aloneThank 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