Sorenson Development Inc. – Revalidation&Part 11

Company: Sorenson Development Inc
Date: 10/17/01
Product: Infusion pumps and other medical devices

Failure to validate processes with a high degree of assurance where the results cannot be fully verified by subsequent inspection and testing, and have those processes approved and documented according to established procedures, as required by 21 CFR 820.75(a). Specifically, revalidation of the microprocessor software used in the Palm Pump has not been completely performed following an engineering change in April 2001. Additionally, computer and/or automated data processing system software used in production and quality systems, including the use of electronic signatures, has not been validated.

Failure of management to perform effective reviews to ensure the quality system satisfies the requirements of 21 CFR 820 and the manufacturer’s established quality policy and objectives as required by 21 CFR 820.20(c). Specifically, management review failed to take appropriate corrective and preventive action to establish authority and independence for Quality Control or to perform computer systems validation, although management was made aware of these deficiencies.

FDA District: Denver District Office

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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