Reframing pharmaceutical production around process stability, real-time quality assurance, and regulatory alignment in the ...
Regulatory officials and industry scientists participated in a CMC Strategy Forum sponsored by CASSS in July 2015. To ensure that biotech manufacturing processes can consistently deliver high quality ...
Continued process verification (CPV) is the third stage of the product lifecycle of any medicine either within the small or large molecule arena. The CPV is the subsequent step to process design ...
It’s a wonder that any electronic system works as intended, or that it continues to work months or years after it is sold. The reason: SoCs have become so complex that no verification coverage model ...
This article overviews some of the benefits and methods of state-based control as it applies to the models defined by the ISA106, Procedure Automation for Continuous Process Operations standards ...
A lifecycle approach can be used to develop GMP-compliant cleaning procedures for continuous manufacturing of solid-dosage pharmaceuticals. It is now possible, as demonstrated by Janssen (1), for drug ...
SAN FRANCISCO--(BUSINESS WIRE)--ValGenesis, Inc., the market leader in enterprise Validation Lifecycle Management Systems (VLMS), has acquired Portugal-based 4Tune Engineering (4TE), a leader in ...
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