Successful risk management is essential to the design and development of safe and effective medical devices. Unfortunately, it is too often viewed by manufacturers as an isolated activity that must be ...
Businesses are facing constant changes, especially after a year like 2020. As such, risk management is crucial. And a tactic many organizations use to tackle risk and compliance is mapping controls.
New AI-powered Archer Assurance AI automatically maps regulatory updates to control and policy procedures, performing gap and conflict analysis and auto-generating missing controls to help reduce ...
Jochen Schwenk is CEO of Crisis Control Solutions LLC & Schwenk AG, an expert in risk and crisis management for the automotive industry. Risk management is a critical component of daily life and, of ...
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, ...
Once the risk team has been assembled, the crucial process of identifying risks must commence. The output of the risk ...
Nobody really likes being audited, but it's an important function to ensure the practices and policies of a company and/or individual are above board. And, as with all jobs, someone's gotta do it.
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