Although some aspects of process validation for continuous processes are the same as those for traditional batch processes, there are some unique considerations. Although some aspects of process ...
ValGenesis, Inc., the global leader in enterprise digital validation, successfully concluded two ValConnect Innovation Day ...
Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...
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 ...
Robotics, semiconductor equipment, and intelligent automation systems are evolving at an accelerating pace, placing OEM ...
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 ...
ValGenesis Inc., the global leader in digital validation lifecycle management, today announced that an international ...
In pharmaceutical manufacturing, cleaning validation is an essential stage of verifying that the manufacturing process is suitable. As an integral stage of the cleaning validation program, analytical ...
Philadelphia-based elastomer specialist integrates French 3D printing technology to speed prototyping and reduce tooling risk ...
The pharmaceutical industry is undergoing a transformative era driven by increasingly stringent global regulatory requirements, significantly impacting operational processes, particularly those ...
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