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AN AUDITING FRAMEWORK TO SUBSTANTIATE ELECTRONIC RECORDKEEPING PRACTICES
Citation:
Brilis, G M. AN AUDITING FRAMEWORK TO SUBSTANTIATE ELECTRONIC RECORDKEEPING PRACTICES. Presented at 220th ACS National Meeting, Washington, DC, August 20-24, 2000.
Impact/Purpose:
The overall objective of this task is to provide the Agency with improved science guidance and strategies for more effective science management and administration.
Description:
Quality assurance audits of computer systems help to ensure that the end data meet the needs of the user. Increasingly complex systems require the stepwise procedures outlined below.
The areas reviewed in this paper include both technical and evidentiary criteria. Increasingly, there has been a trend to use computers in data acquisition and transmission. Many existing audit programs do not address issues regarding integrity of computer-resident data. The U.S. EPA's Office of Information Resource Management (OIRM) addressed the issue of integrity of laboratory data through the development of Good Automated Laboratory Practices (GALP).
In order to assist quality assurance professionals as well as others interested in conducting audits of computer systems, the authors have developed an audit approach based on requirements described in the GALP. The requirements of the GALP have been modified and amended to be applicable to automated onsite computer systems. The checklist serves two purposes. The first is an auditing aid. The second is as documentary evidence of awareness of computer related QA issues.