Recently, under its new Insights offering, KenX published an article, The Big Reshuffle – Impact Assessments and System Criticality, discussing the implications regarding the change in approach from System Level Impact Assessment (SLIA) and Component Criticality Assessment (CCA) to System Classification (SC) and System Risk Assessment (SRA) in ISPE Baseline…
In today’s highly competitive environment, eliminating unplanned downtime is more important than ever, especially when that downtime occurs during a batch that places the product at risk. Did you know “best-in-class” maintenance organizations spend 90% of their total maintenance time on proactive maintenance (planned, kitted and scheduled corrective, preventive, and…
As an essential business, which must continue functioning in the current global environment, Pharmaceutical Manufacturing companies face unique challenges. Pharmaceutical Manufacturing relies on operating in a controlled state, which stems from Quality Systems in six significant areas. With the current COVID-19 outbreak, this may require adjustments to the way the…
Computer Software Assurance (CSA) for Manufacturing, Operations, and Quality System Software Guidance – Is it the solution to arduous validations that the life science industry has been waiting for from the FDA? Least Burdensome Approach to Validation – the Food and Drug Administration (FDA) has been pushing this concept onto…
Technology Transfer and the Product Lifecycle Technology transfer is integral to the lifecycle of virtually every pharmaceutical product. Tech transfer enables a product to advance from the development lab into clinical manufacturing and then scale-up to commercial production. As demand grows, tech transfer is instrumental in adding additional manufacturing capacity…
Preservation Program What are Capital Spares? A Capital Spare is a piece of equipment, or a spare part, of significant cost that is maintained in inventory for use in the event that a similar piece of critical equipment fails or must be rebuilt.
Every organization has some “big problem” that they need to address. New software, sensors, equipment, or analytics can sometimes be the solution to that problem. But sometimes there is a nagging thought that the real issue is more institutional than asset-based. Almost universally, companies that successfully leap into the Internet of…
“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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