Baxter Healthcare Corp. – Part 11

Company: Baxter Healthcare Corp.
Date: 8/11/00
Product: Drug Products

Failure to conducted and/or document input/output checks of the _____ computer system. [21CFR211.68]

In addition, we further request details regarding steps your firm is taking to bring your electronic cGMP records into conformance with the requirements of 21 CFR Part 11; Electronic Records; Electronic Signatures. Part 11 establishes requirements to ensure that electronic records and electronic signatures are trustworthy, reliable and generally equivalent substitutes for paper records and traditional handwritten signatures. Electronic records and electronic signatures may be used to meet record and signature requirements of 21 CFR Parts 210 and 211 when Part 11 requirements are met.

This inspection disclosed deficient controls in the laboratory electronic record keeping system, which is used for maintaining chromatographs and audit trails. In addition to a response to the deficiencies noted earlier in this letter, please outline your firm’s global corrective action plan, including timeframes for correction, to address this Part 11 issue.

FDA District: Chicago 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.

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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