Thoratec Laboratories – Access Database

Thoratec Laboratories 3/10/00″..4. .The implementation of corrective and preventative action (CAPA) procedures at your firm is incomplete in that your procedures do not include reference to the Access electronic database. This database captures information from sources such as complaints and nonconformance reports for use during management reviews. In addition, battery assembly defects, such as loose connectors, were recognized by the UPS assembly inspector. However, the defective assemblies were reworked without generation of a nonconforming product report. [21CFR 820.100(b)] ”

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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