Validation engineers design or plan protocols for equipment or processes to produce products meeting internal and external purity, safety, and quality requirements. Natural problem-solvers, ...

Validation ensures that a part will operate correctly in end-user applications. Design validation is the task of testing a part or a system adequately to ensure that all parts or systems manufactured ...

The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ ...

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 ...

NEW YORK & TEL AVIV, Israel, June 09, 2025--(BUSINESS WIRE)--Cymulate, the leader in threat exposure validation, today announced the release of its powerful new AI-powered detection engineering ...

The rate of technological advancement is increasing faster than ever before. Although the demands for meeting aggressive time-to-market requirements and innovating at warp speed are not new, they are ...

In 1987, when the US Food and Drug Administration issued its Guideline on General Principles of Process Validation, a young FDA reviewer asked her supervisors. In 1987, when the US Food and Drug ...