On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...
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 ...
Korrapati's implementation work is complemented by industry engagement, including presenting on CSA implementation and roadblocks at professional venues ...
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 ...
Computer systems analysts study an organization's current computer systems and procedures and make recommendations to management to help the organization operate more efficiently and effectively.
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