QRM and the System Classification “Big Reshuffle”: Don’t Miss the Forest for the Trees
Recently, under its new Insights offering, KenX published an article, The Big Reshuffle – Impact Assessments and System Criticality, discussing the implications regarding the change...
Read MoreUnderstanding Failure to Ensure Proactive Maintenance
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...
Read MoreYou Can’t Distance From Quality
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...
Read MoreIs CSA Really a Game Changer for the Life Science Industry?
Computer Software Assurance (CSA) for Manufacturing, Operations, and Quality System Software Guidance – Is it the solution to arduous validations that the life science industry...
Read MoreBest Practices in Technology Transfer
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...
Read MoreThe Forgotten Capital Spares
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...
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