Process validation plays a critical role in the success for a new biopharmaceutical on the path of commercialization, including the crucial process characterization. As a program advances towards ...

SANTA CLARA, Calif., February 27, 2026--(BUSINESS WIRE)--ValGenesis Inc., the global leader in digital validation lifecycle management, will showcase its Process Lifecycle Suite, part of the ...

ValGenesis Smart GxP™ is the first AI-enabled platform purpose-built to unify validation and process development across the product lifecycle. Featuring five integrated applications—ValGenesis iCMC™, ...

European Medicines Agency (EMA) which has been following the US FDA guidelines on Process validation so long, has now revised the process validation norms. The revision incorporates the principles of ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

This article proposes an independent structured review process for legacy products—those pharmaceuticals that predate FDA’s updated process validation and quality by design [QbD] guidance. This ...

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 ...

Process validation, including process characterization, is a critical step in the successful commercialization of a new biopharmaceutical on its path to commercialization. As the program approaches ...

SANTA CLARA, Calif.--(BUSINESS WIRE)--ValGenesis, Inc., the global innovator in digital validation lifecycle management, today announced the launch of ValGenesis Smart GxP ™, the first AI-enabled ...

ValGenesis Inc., the global leader in digital validation lifecycle management, will showcase its Process Lifecycle Suite, part of the ValGenesis Smart GxP™ platform, at BioProcessing Summit Europe ...