Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
News|Articles|July 1, 2001
- Pharmaceutical Technology-07-02-2001
- Volume 25
- Issue 7
The Future State of Computer Validation, Part I
Author(s)Rory Budihandojo
Current events and trends in regulations, business practices, and technology forecast the future of computer validation.
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Articles in this issue
over 25 years ago
Musings on the Past 25 Yearsover 25 years ago
Reflections on Changes at FDAover 25 years ago
Deliver the Doseover 25 years ago
Middle-European Pharmaceutics in a Changing Worldover 25 years ago
The BCS: Where Do We Go From Here?over 25 years ago
From Inactive Ingredients to Pharmaceutical Excipientsover 25 years ago
Am I Going Backwards?over 25 years ago
The Filter Scene: Old and Newover 25 years ago
Catching Up with Expert SystemsAdvertisement
Related to this article
Manish Baviskar, Hubot CDMO, explains which AI skills validation engineers need first and why AI model updates must go through GMP change control.
FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.
FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.
FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
FDA final guidance defines when companion app output counts as drug labeling and when device-connected or standalone apps belong in prescribing information.
The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.
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