Top Maintenance Trends in FDA Inspections

The FDA is displaying heightened interest in maintenance and asset management during inspections.  Along with the future adoption of ISO 55000 scheduled for February 2014, there is a strong focus on asset management and a drive toward risk-based maintenance standards...

Pipettes in a Regulated Environment

For me, all of this started not with pipettes, but with automatic burettes. We were in fact not allowed to use pipettes in that laboratory, in favor of class ‘A’ volumetric glassware. The sample preparation deliveries supported HPLC test methods, and I can’t say I...