Undertaking process validation involves a major commitment in terms of personnel, resources, time, and money. Performing prerequisite verifications can reduce the risk of making costly mistakes. This ...

Overview: Process Validation is required by FDA and most regulatory bodies. PV demonstrates consistency of pharmaceutical processes. PV requires writing and executing a validation protocol that ...

The new industrial revolution, “Industry 4.0,” has been leading to changes in the pharmaceutical industry (“Pharma 4.0”), where significant paradigm shifts have been occurring in the pharmaceutical ...

ValGenesis, Inc., the market leader in digital validation lifecycle management solutions, announced that a global pharmaceutical and biotechnology leader has successfully expanded its use of the ...

Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...

The pharmaceutical industry is undergoing a transformative era driven by increasingly stringent global regulatory requirements, significantly impacting operational processes, particularly those ...

SAN FRANCISCO - ValGenesis Inc., a market leader in Enterprise Validation Lifecycle Management Systems (VLMS), today announced that a global pharma giant has gone live with ValGenesis VLMS “ the ...

Despite their frequent interchangeable use, understanding the distinction between validation and qualification is critical in pharmaceutical environments. Validation is a broader concept encompassing ...

The pharmaceutical industry is undergoing a transformative era driven by increasingly stringent global regulatory requirements, significantly impacting operational processes, particularly those ...

SANTA CLARA, Calif., March 26, 2025--(BUSINESS WIRE)--ValGenesis, Inc., the market leader in digital validation lifecycle management solutions, announced that a global pharmaceutical and biotechnology ...