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What happens when something goes wrong? CAPAs for Equipment

What is a CAPA? It is the acronym given to Corrective and Preventative Action, as defined by the FDA. A CAPA is triggered when a product, process, or documentation has a non-compliance issue. CAPAs can be triggered from small or large issues. A small issue might be...

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The Importance of Computer Systems Validation

The Importance of Computer Systems Validation

PSC Biotech can provide you the highest quality CSV services on any scale. Computerized systems and software validation (CSV) provides evidence that your systems are compliant with current regulations and are suitable for their intended purpose. You want to proactively perform computer systems validations to ensure that your systems do what you intend, maintain data integrity, and meet regulatory agency requirements.

SuperVision Launches Today!

SuperVision Launches Today!

Pomona – 06/10/2021 – PSC Biotech® and PSC Software™ today announced the immediate availability of the Beta version of ACE SuperVision, a module that integrates wearable technology devices with PSC’s™ Adaptative Compliance Engine® (ACE™).  ACE SuperVision Beta allows...

Effective Risk Management For Medical Devices

Effective Risk Management For Medical Devices

Risk Management is your system of management policies, procedures, analysis practices, and monitoring risk.  An effective risk management program is an essential element in the life cycle of a medical device.     A Hazard is a potential source of harm.  A Risk is your...

Starting A New Laboratory

Starting A New Laboratory

Written By: Matthew Greer, Technical Writer, PSC Biotech®Introduction Starting up a new laboratory can be a daunting task. What regulations need to be followed?  What kinds of products are you handling?  What kinds of tests will you do? Once you know this, you need to...

What is Method Transfer, and Why is it Important?

What is Method Transfer, and Why is it Important?

Written By: Mattew Greer, Technical Writer, PSC Biotech®When bringing new products from one facility to another or from a product development to production environment , understanding the requirements for the transfer of validated analytical methods used for testing...

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