Articles by tag: regulatory compliance
Commissioning Good Manufacturing Practice (GMP) facilities is a critical yet complex component of the manufacturing sector, especially as facilities grow in sophistication and the standards for quality and safety heighten. Ensuring that clean rooms, HVAC controls, power systems, and other utilities meet stringent requirements is no small feat. Challenges such as permit delays, documentation…
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Amend & Progress
The Key to Smooth Audits is Effective Document Management Strategies
In the regulatory landscape, audits serve as essential benchmarks for ensuring organizational compliance and risk mitigation. As regulations grow more intricate, the importance of effectively managing audits has escalated. This timely discussion is crucial as a single oversight can result in considerable financial and reputational harm. So what does it take to turn the…
Flawless Execution
Flawless Execution: The EU Lot 9 Standard — A Firmware Update and Review
Host of UNICOM Engineering’s Flawless Execution podcast, Tyler Kern, excitedly welcomed the show’s first guest, Mike Cantwell. As the global regulatory compliance manager with UNICOM, Cantwell is an expert on regulatory processes, including the European Union (EU) Lot 9. UNICOM works with many software companies to configure branded hardware and ship the finished product to…