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Life Sciences
CDRH Report: Quality Management Insights For Medical Device Manufacturers
FDA's Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH [...]
Prioritize QMS Process Automation or Risk Failure
A common pitfall in QMS process automation occurs with a poorly planned process automation strategy. Too often, the tem [...]
Successful QMS Implementation Requires Clearly Defined Processes
Industry-leading quality management systems (QMS) are built with clearly defined processes and workflows developed by th [...]
China Addresses Life Sciences Regulatory Compliance Concerns
China has often faced criticism for lax regulation of drug and medical device manufacturing. In addition, long-term accu [...]
FDA Warning Letters Emphasize Document Control System Compliance
First-quarter 2017 Food and Drug Administration (FDA) warning letters emphasize a lack of effective document control sys [...]
FDA States Clear cGMP Expectations for Combination Products
The Food and Drug Administration (FDA) recently released a final guidance on Current Good Manufacturing Practice (cGMP) [...]
