Blog

Understanding Failure to Ensure Proactive Maintenance

July 30, 2020 ||
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…

You Can’t Distance From Quality

June 15, 2020 ||
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…

Is CSA Really a Game Changer for the Life Science Industry?

June 11, 2020 ||
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…

Best Practices in Technology Transfer

May 28, 2020 ||
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…

The Forgotten Capital Spares

May 26, 2020 ||
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.

Achieving Capital Project Success Through Organizational Maturity

April 16, 2020 ||
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…