Computer software assurance (CSA), the FDA's new framework for computer system validation (CSV), is being heralded as a game-changer. While the promise of simplified, less costly validation is ...
Risk is a lens, not a leash. Once teams see what truly threatens patients and processes, the busywork falls away, and quality ...
SCHWEINFURT, Germany (Dec. 5, 2007) -- Over the past several years the U.S. Army has invested billions of dollars in computer software, hardware and equipment to keep up with the world's ever-changing ...
In modern integrated computer systems, assurance activities such as assessments, tests, and audits are increasingly difficult to perform in multi-party environments. But there are a few key tactics ...
As part of the Case for Quality program US FDA Center for Devices and Radiological Health noted how an excessive focus by industry on compliance rather than quality may be diverting resources and ...
The Computer Software Assurance (CSA) industry is experiencing rapid digital transformation as organizations prioritize robust software validation and compliance. Growing regulatory mandates and the ...
Critical Manufacturing, a subsidiary of ASM Pacific Technology, and Dataworks, a provider of innovative software solutions and validation services to the life sciences sector, today announced a ...
InstantGMP™, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its software development and validation practices ...
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