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A Deviation has Occurred. What’s Next?
Something went wrong during the manufacturing process; there was a piece of equipment used that was overdue. The error has now become a deviation. What is a deviation? A deviation is an action of departing from an established course or accepted standard. Processes are...
The Importance of Validation
Validation is the collection and evaluation of data, from the process design stage through production, which establishes scientific evidence that a process and or device can consistently deliver a quality product. Process validation involves a series of activities...
ISO 17025 accreditation explained
Are you a laboratory? Do you perform any sampling, calibrations, or testing? Then, the International Organization for Standardization (ISO) asks you, Are you technically competent? Here we explain ISO/IEC 17025 accreditation of the general requirements for the...
The Complete CQV: Where to Start
Commissioning, Qualification and Validation (CQV) in the life science pharmaceutical and medical device industries define a detailed and science-based process for the specification, design, and verification of new equipment or systems into a production pipeline. In...
Fulfilling Requests During an Inspection
In this blog article series on regulatory affairs inspections, we talked about the importance of making a good impression when the inspector or investigator arrives and how to do that. To prepare for the inspection – which can happen anytime – we talked about putting...
Metrology 101
Why you need a calibration program Metrology is the scientific study of measurement. If you make things, you need to calibrate the buildings, equipment, and processes that you use to make things. If it moves or measures and doesn’t breathe, it might need calibration....
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