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 ...

In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...

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 ...

In the context of current good manufacturing practice (cGMP), a number of pharmaceutical manufacturers are incorporating Process Analytical Technologies (PAT), Quality by Design (QbD), or Process ...

"Risk-based" is the phrase every compliance deck has carried for fifteen years. It has rarely meant risk profiles derived ...

As part of current good manufacturing practice (cGMP), many pharmaceutical manufacturers are adopting Process Analytical Technologies (PAT), Quality by Design (QbD), or Process Validation (PV) to ...

Technological innovations throughout the past several decades have transformed the pharmaceutical manufacturing process from traditional batch production to ...