17
Apr
2000

Limberg Eye Center

0

Limberg Eye Center 4/17/00

Failure to maintain complete and accurate records [21 CFR 812.140(a)]. Information on some of the case report forms (CRFS) did not agree with the computerized subject records and vice versa for those records that were originally captured on the CRF and then transcribed to the computerized source records. Moreover, UCVA readings are incorrectly entered for some BSCVA results on CRFS that only have provision to record the BSCVA.

SoftwareCPR keyword: electronic records.

CDRH Office of Compliance

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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