Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
|Articles|June 1, 2005
- Pharmaceutical Technology-06-01-2005
- Volume 205 Supplement
- Issue 3
The Part 11 Controversy: A Root Cause Analysis and Science-Based Solutions
The confusion surrounding the application of 21 CFR Part 11 can be solved by focusing on the common rationale that both protects the public health and drives the fundamental basis of the industry's business: good science.
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Manish Baviskar, Hubot CDMO, explains which AI skills validation engineers need first and why AI model updates must go through GMP change control.
Cole and Jaenisch dig into AI poisoning in pharma manufacturing, how it hides in plain sight, and who should be accountable for catching it.
Jaenisch, Muraru, and Pandey discuss how regulators will audit pharma against its own AI policies and ways QA and regulatory teams can build defensible, inspection-ready AI practices.
Mitigating nitrosamine risk requires assessing each product individually and chasing zero nitrite in pharmaceutical excipients is often impractical and costly.
The business case for regulated AI turns on the cost of producing an outcome that the quality system can accept.
In October, FDA reorganized rare disease development around a fit-for-purpose framework and a new pathway for individualized gene editing. Regulators in Europe and the UK set out long-term plans for clinical trials, AI, and moving away from animal testing.
Clinical, manufacturing, safety, and commercial teams all lean on shared data. They need to agree on who publishes each data product, who can use it, and what evidence goes with it.
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