Risk-based approaches to commissioning and qualification (C&Q) is a common standard for site and project plans. What does that mean and why is there so much implementation variability across the industry? Our CQV benchmark initiative is focused on:
Here’s an excerpt from this whitepaper: “The hallmark of a high performing organization is the cultivation, use, and continuous improvement of their processes used to monitor and evaluate performance. As such, many organizations continue to struggle to reach a high level of performance in delivering projects, not because they don’t…
A mission critical facility’s greatest liability to maintaining uptime is power quality. But why is power quality so important to a Data Center’s operation? Because the quality of power to the IT equipment directly impacts the equipment performance, uptime, and potential damage to equipment. The key to power quality is…
The expansion of edge computing, powered by the Internet of Thing’s (IoT) uprising tide, brings the unique opportunity to turn a world full of data into a data-driven world. Many applications of IoT, such as industrial automation processes, smart healthcare, and self-driving cars, require a compute infrastructure that sits closer…
This whitepaper examines “The Capital Project Model – Limitations, Pitfalls, and Short Comings” as it related to Building Commissioning efforts as well as “An Alternative Method – Combined Funding, Benefits, and Advantages.” Written by Jay Congdon, CEM, CEA, CBCPM, CBCP, EBCP, CMVP Jay has 12 years of experience providing Building…
Having led many large capital projects around the world that had very strong safety records, I was asked by an HSE leader about my approach for creating and inspiring a strong safety culture… this was my response:
In the biotech industry today, mergers, acquisitions, and joint ventures are announced daily. Startup companies with viable molecules must decide early how they get a drug into trials, and eventually to the marketplace, as rapidly as possible. Contract research organizations (CROs), contract development and manufacturing companies (CDMOs), and dedicated contract…
The FDA’s 12 month delay in enforcing the Drug Supply Chain Security Act (DSCSA) requirement for all RX products in cases to be serialized was meant to give industry more time to comply with the new regulation, but this extra time does not modify the Act or change the enforcement…
“The ultimate goal of providing a robust, safe method to transfer solutions in the Manufacturing Facility was achieved and CAI played a major role with this safety initiative.”
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