Grand Rapids-Part 11 issue Complaint Handling

Company: Grand Rapids
Date: 10/1/01
Product: Thumper cardiopulmonary resuscitator

Your response to FDA-483 point #6 regarding 21 CFR Part 11 – Electronic Records is not adequate as explained in more detail below.

21 CFR Part 11
During the FDA inspection it was discovered that electronic records are used to establish the firm’s Complaint Files, 21 CFR 820.198. However there is no documentation to establish that these electronic records meet the requirements of 21 CFR Part 11, Electronic Records; Electronic Signatures. The requirements of 21 CFR Part 11 are designed to ensure that electronic records are trustworthy, reliable, and generally equivalent to paper records.

For example, review of your electronic complaint files reveals they have not been properly validated, there is no ability to generate accurate and complete copies of records in human readable and electronic form, there is no protection of records to enable their accurate and ready retrieval, access to your system has not been limited, as well as other significant deficiencies. We strongly encourage you to perform a thorough and complete evaluation of all your electronic records in accordance with 21 CFR Part 11 as well as any guidance generated by FDA to assure conformance to our requirements. Do not limit your evaluation solely to the examples cited above. Only electronic records and electronic signatures that meet 21 CFR Part 11 may be used to satisfy the requirements of 21 CFR 820.198, Complaint Files.

FDA District: Detroit 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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