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Wrapping Up the Inspection

This series on inspection success has stressed the importance of making a good first impression,  preparing your inspection management team, using inspection management software, who to have available during an inspection, and how to fulfill the inspector’s requests....

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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...

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