Sani-Pure Food Laboratories – Part 11

The computer software your firm uses to determine metals analysis is deficient. It has no security measures to prevent unauthorized access of the software, no audit trails, and data can be copied or changed at will, with no documentation of the copying or changes. Your procedures do not require the documentation of calculation or entry errors. There is no documentation to indicate that analysts are trained in the software and its applications.

Also, you or your employees discarded documentation of analytical work performed prior to September 1999. As a consequence, that documentation was not available for review during our inspection. The lost documentation, attributable to flood waters entering your facility, was improperly stored to prevent such an occurrence. In addition, photocopies, electronic data or some other facsimile to the lost documentation were not generated. h the future, you should develop more secure record storage facilities and procedures to prevent record loss due to natural disasters or other unforeseen circumstances.

SoftwareCPR Keywords: Part 11 Electronic Record Electronic Signatures

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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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