Sambit Mohapatra

Novartis
Associate Director Program Management

Related Articles

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computerized system validation (CSV) received a strong push in the second half of 2022 with the publication of the FDA draft guidance on “Computer Software Assurance for Production and Quality System Software”

Article
iSpeak Blog
Synergy between ISMS & GxP Compliance for value add in Pharma IT

The Covid pandemic has pushed all companies to accelerate their digitization plans and ramp up adoption of emerging technologies. For regulated companies like Pharma, which operated in secure offices and fortified offshore development centers, this has also meant new ways of working and additional challenges in cybersecurity. Furthermore, with the need for agility in cases like developing the...