Sambit Mohapatra

Novartis
Associate Director Program Management

Related Articles

iSpeak
iSpeak Blog
The Dual Role of AI in GxP IT Validation: Validation Enabler and Validation Subject

Artificial intelligence has entered GxP IT validation in two distinct but connected ways—as a tool that helps to perform validation work and as a system that itself requires validation. This blog post explores the dual role of AI and considers how the Validation 4.0 framework can be applied and extended in the AI era.

Concluding Validation-750px
iSpeak Blog
Concluding Validation 4.0 with Computer Software Assurance (CSA) and Annex 11 Framework
In the last ISPE article developed by this author, titled “Concluding Compliance Challenges with Validation 4.0”, seven pillars of Validation 4.0 were identified as necessary to support the key themes of Pharma 4.0™ operating model. The article concluded with a caveat that only the final publication of CSA guidance will provide a definitive answer to this conundrum. Now with the publication of...
Concluding Compliance Challenges with Validation 4.0
Technical
Concluding Compliance Challenges with Validation 4.0

As the pharma industry moves to an ambitious Validation 4.0 paradigm, computerized systems play a pivotal role in enabling the rapid transition. Innovation and agility in computerized system validation (CSV) received a strong push in the second half of 2022 with the publication of the FDA draft guidance on “Computer Software Assurance for Production and Quality System Software”