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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
FDA revised guidance documents for low-risk wellness products and clinical decision software, clarifying regulatory ...
Document Control Systems Inc. (DCS), a Salt Lake City-based provider of integrated quality management software solutions, is offering a free white paper and downloadable presentation discussing ...
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 ...
BOSTON--(BUSINESS WIRE)--Sware, provider of the most complete software validation solution for innovative life sciences companies, today announced that it raised $6 million in Series B funding, ...
Software is a significant part of any modern manufacturing operation, and FDA requires validation of such software used for regulated processes. Companies are often confused, however, about when and ...
The guidance, posted online on November 4, intended to provide information regarding the recommended documentation to include in premarket submissions for the FDA to evaluate the safety and ...
Inadequate process validation is one of the most common issues leading to warnings from the US Food and Drug Administration (FDA). It may also be the most difficult to address, according to Max ...
Inadequate process validation related to medical devices was cited more than 600 times by the US Food and Drug Administration (FDA) in 2013. In efforts to meet the agency’s standards, device ...
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