FDA CDER Drug Quality System Inspection Pilot

FDA is piloting GMP inspections for Drug manufacturers based on a quality system style inspection. The end of the pilot period is June 30, 2001. The pilot districts are:
“Pilot Districts: Philadelphia, Los Angeles, New Jersey, New York, San Juan, and Dallas. For DOMESTIC INSPECTIONS ONLY.”

The guideline (CPG7356-002 Draft) at the link provided mentions validation of computerized systems in several places including for inventory control systems, laboratory control systems, and data handling systems.

Slides from a presentation on this pilot by Joseph C. Formulare of CDER are available at ASQ Presentation Slides

and contain numerous references to validation in general and computer validation in particular.

SoftwareCPR keywords: Drug validation, CSV, qualification.

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.


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