The Importance of Validation
Validation is the collection and evaluation of data, from the process design stage through production, which establishes scientific evidence…
ISO 17025 accreditation explained
Are you a laboratory? Do you perform any sampling, calibrations, or testing? Then, the International Organization for Standardization (ISO)…
Fulfilling Requests During an Inspection
In this blog article series on regulatory affairs inspections, we discussed the importance of making a good impression when the inspector…
Metrology 101
Why you need a calibration program Metrology is the scientific study of measurement. If you make things, you need to…
Preparing for an inspection: Building an Inspection Team
Site inspections regularly check and verify your organization’s regulatory compliance, safety standards, and more. The FDA, EHS, and the…
The Importance of the Appropriate Architecture in Your GxP Computerized Systems
Written by: Justin Jay, Director of Mid-Atlantic Operations Computerized systems are critical to reducing the cost and complexity to…
