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 ...

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 ...

SAN FRANCISCO, Feb. 12, 2019 /PRNewswire/ -- ValGenesis, Inc. today announced that one of the world's largest, top rated life science companies has chosen to implement ValGenesis's 100% paperless ...

Qualification/validation can be defined as “establishing documented evidence which provides a high degree of assurance that specific equipment procured will ...

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 ...

As technology capabilities and customer requirements have evolved, so have gas turbine testing and validation methods. Mitsubishi Hitachi Power Systems believes the proof of its long-term validation ...

No additional expectations or mandated requirements are expected in Q14, Q2(R2) and USP <1220>. The minimal approach can still be used. Q14 and Q2(R2) are consistent with the principles described in ...

ValGenesis VLMS provides a holistic view of the Validation process throughout the company with validation activities accessible in real-time from a convenient dashboard within ValGenesis. VLMS ...

SAN FRANCISCO, March 29, 2019 /PRNewswire/ -- ValGenesis, Inc., a market leader in Enterprise Validation Lifecycle Management Solutions (VLMS), today announced that FDC has chosen ValGenesis's 100% ...

Laser micromachining is a versatile process that can be used for an array of medtech applications. Yet when using it, it is crucial to select the appropriate method of process qualification or ...

The automated validation lifecycle management system will help the life sciences industry say goodbye to paper and remove the inefficiencies that plague today`s IT validation processes. Copenhagen, ...