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Y. Tsau, O. Dembinska, K. Burke; Implementation of GLP/GCP and 21 CFR Part 11 Compliance in Visual Electrophysiology System . Invest. Ophthalmol. Vis. Sci. 2006;47(13):1670.
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© ARVO (1962-2015); The Authors (2016-present)
To implement a novel procedure for acquiring, displaying, storing, and analyzing data of electrophysiology studies in order to comply with FDA's 21 CFR part 11 regulations and so to achieve more reliable and accurate assessment in visual electrophysiology for good practice in both basic research and clinical studies.
Efforts have been made to maximize the traceability of the data of electrophysiology involved in GLP/GCP studies. 1. All related data and operations in each GLP/GCP study are recorded in a single encrypted and inseparable database. 2. All users involved in the study are registered and assigned with variable privileges (super–user, analyst, viewer, and disabled). The accounts are protected by passwords. 3. The study protocol is predefined and cannot be changed during the study. Replication of any recording requires justification explanation. 4. All user actions related to the data being studied are audited and traceable in an audit trail. 5. All output of the GLP/GCP study related data are stamped with user, date, and time. 6. All recordings are permanently stored and cannot be modified. 7. The database can be accessed only via EMWin GLP/GCP software package protected by multiple levels of security.
The UTAS–E3000 system has been installed and tested in pharmaceutical and academic settings. GLP study databases were created by an administrator, and the users involved in the study were assigned in only by the administrator. Each time the user had to log into the study with a valid username and password before the study procedures were enabled. All data collection was restricted by the unchangeable protocol. Attempts of altering data collections were prompted with justification inputs. All data access related activities, such as data display, analysis, and printout were audited and stored in the audit trail. The audit trail was viewable by the administrator.
The newly developed ERG module allows for 21 CFR part 11 compliance and supports GLP/GCP electrophysiology studies in terms of data originality and operation traceability. The experimental data are safely stored and patient's information is secured. Uniformity of data collected in the multi–center trials or research activities can therefore be easily achieved. The restrictedly tested procedures will ensure the results that can be fully trusted by FDA and customers.
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