Electronic Record Challenges for Clinical Systems

Abstract

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 II's 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, identification of a system “owner” for a cross-functional application, and delegated responsibilities.