The FDA has released a draft guidance outlining how drug developers can validate new approach methodologies (NAMs) as ...

Guide covers ISO 17025 lab requirements and how brands can verify compliance before choosing a testing partner. IRVINE, ...

Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.

An expert illustrates why test method validation is important in the real world. José Ignacio Mora Tom was ready to send the multi-cavity fixtures. I asked him to perform a Gage Repeatability and ...

Approved by the Royal Society of Chemistry for purposes of continuing professional development. This course will provide you with the requisite scientific knowledge and understanding of analytical ...

Software testing, verification and validation form the backbone of modern software quality assurance. These interrelated activities ensure that a software system accurately implements its intended ...

This is something I have heard a lot recently. But it’s not true. The Quality System Regulation 21 CFR Part 820 includes requirements for design controls. The regulation requires design validation to ...