Rappahannock Eye Center

Failure to investigate adverse device effects;failure to install password clearance on computer

You failed to investigate the failure of the _____ when operating in MS Access. The system locks up at random and it is unknown whether the software which controls the _____ during _____ which operates off of MS Excel, could be similarly affected. Disruption of the _____ or an incorrect _____ pattern could result from such an occurrence. According to an Office of Device Evaluation (ODE) medical reviewer of _____ investiagational studies, it is not known if there is any irreparable damage to _____ when and if _____ are interrupted in the course of a prescribed _____ pattern. However, irregular _____ leave the patient with a refractive error that is uncorrectable by any means to date.

No security password is used on the computer for entering of data or when sending data to the study monitor over the internet. Subject medical records are, therefore, easily accessible. 21 CFR 812.100 states that an investigator is responsible for ensuring the rights and welfare of subjects, which includes security of their records.

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT


Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
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QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
Registration Link

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