Electronic Record Challenges for Clinical Systems
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Drug Information Journal, Vol. 35, pp. 721-730, 2001 Printed in the USA. All rights reserved.
ELECTRONIC RECORD CHALLENGES FOR CLINICAL SYSTEMS LISAOLSON Principal Compliance Consultant, SEC Associates, Inc.. Morrisville, North Carolina
Much of the attention and many of the articles that have been written on computer system validation and the Food and Drug Administration S Electronic Records/Electronic Signatures Rule (21 CFR 11) have focused more on the Good Manufacturing Practice and Good Laboratory Practice areas than on the clinical arena. Clinical systems and issues are much more data oriented than equipment based, and tend to be more complex. As such, they have their own areas of concern. Part 11 has expanded the scope of systems needing validation beyond the traditional large clinical data management repository. Part 11 k influence requires that multiple parties in an organization combine their expertise for successful system implementations. Clinical application considerations also include: Large networked systems, lengthy data retention requirements, increasing use of purchased software applications, a broad user base, becoming paperless, identijication of a system “owner”for a cross-jhctional application, and delegated responsibilities. Key Words: Computer validation; 21 CFR 1 1 ; Computer systems; Clinical applications; Clinical database
MUCH HAS BEEN WRITTEN, presented, taught, and discussed in the past few years about computer system validation and the Food and Drug Administration’s (FDA’s) Electronic RecordsElectronic Signatures Rule, 21 CFR 11 (Part 11). However, a large part of the focus and examples have been in the Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) areas. Many of the systems in use in nonclinical laboratories, manufacturing plants, and product release quality assurance laboratories control and collect data from instruments and manufacturing line machinery and processes. This heavy equipment emphasis and discussion of chromatographs, programmable logic controllers, high-performance liquid chromatog-
Reprint address: Lisa Olson, SEC Associates, Inc., 3900 Paramount Parkway, Suite 150 South, Momsville, NC 27560.
raphy systems, gas chromatographs, supervisory control and data acquisition systems, distributed control systems, and auto samplers has not been shown to be relevant in the clinical research arena, which typically makes use of more traditional information technology type systems and databases, where the equipment components tend toward mainframes, servers, desktop PCs, and network configuration. In fact, for some time, many felt that systems used in clinical research functions were exempt from Part 11, with the possible exception of the large clinical data repository. As is becoming increasingly clear, the scope and impact of Part 11 extend beyond the equipment-intensive world of GLP and GMP to the heavily dataoriented world of Good Clinical Practice (GCP). Systems used in clinical research have a level of complexity due both to their functionality and
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