FORT BELVOIR, Va. – The Command Service Office (CSO) within the U.S. Army Intelligence and Security Command (INSCOM) operates a rigorous review board as the centerpiece of its contract requirements ...

DUBLIN--(BUSINESS WIRE)--The "Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation): 2-Day Workshop "conference has been added to ResearchAndMarkets.com's ...

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 ...

Virtual system integration and test using Model-Based Design uncovers errors introduced in the requirements and design phases of embedded system development, well before the physical testing phase. As ...

As discussed in my previous post (How to Define Meas urable and Traceable Requirements for SharePoint Projects), focusing on the business requirements first, user requirements second and then ...

FDA’s 21 CFR Part 820 — Quality System Regulation (QSR) has not been updated since it was first released in 1996 . . . until now. Are you ready? Part of a panel at the conference discussing the ...

Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...

A moldmaker said recently that it sometimes takes him up to eight months to validate a large, high-cavity medical mold. Maybe this surprises you, but it doesn’t surprise many OEMs in the medical and ...

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 ...

After years of complaints that it slowed innovation and buried programs in red tape, the Pentagon has officially scrapped the Joint Capabilities Integration and Development System (JCIDS). In an ...