Open AccessImplementation of electronic signatures and records in a clinical CRO: A case study
Author(s) -
Ogg Graham D.
Publication year - 2002
Publication title -
the quality assurance journal
Language(s) - English
Resource type - Journals
eISSN - 1099-1786
pISSN - 1087-8378
DOI - 10.1002/qaj.196
Subject(s) - authentication (law) , computer security , encryption , biometrics , electronic signature , medical record , compliance (psychology) , electronic records , quality (philosophy) , computer science , business , internet privacy , engineering , medicine , database , psychology , process (computing) , social psychology , philosophy , epistemology , radiology , operating system
Implementation of electronic signatures and records incurs special problems in a specialist Phase I clinical unit where rapid communication, rapid reporting, compliance with applicable regulations and high quality are of paramount importance. Both the business needs and the regulatory compliance issues must be considered in any possible solutions and thus some form of authentication of records and communications is required. In our facility, the requirements of 21 CFR Part 11 did not go far enough regarding authentication and were difficult to implement by medical staff collecting data. Biometric authentication of data entry and encryption of communications appeared to be the best solutions. Copyright © 2002 John Wiley & Sons, Ltd.