Auditing New Electronic Systems
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Drug Information Journal, Vol. 32. pp. 1073-1080. 1998 Printed in the USA. All rights reserved.
Copyrighl 0 1998 Drug Information Association Inc.
AUDITING NEW ELECTRONIC SYSTEMS WILLIAMB. STINCHCOMB Project Manager, Research Quality Assurance, Pharmaceutical Products Division, Abbott Laboratories, Abbott Park, Illinois
Sponsors and contract research organizations (CROs) are developing more eficient computerized methods and electronic systems to record and process case report form (CRF) data. New electronic systems vary in complexity and may be represented by a personal computer at an investigator’s site, a CRO site data management technology system, or a sponsor’s fully integrated clinical data management system. Regardless of the type of electronic system used in Good Clinical Practice (GCP) applications, data quality and data integrity are the key areas to assess when auditing new electronic systems. Attributes of a successful electronic system audit include consideration of important planning elements, evaluation and assessment techniques for giving appropriate credit, and specific key areas to focus on during the audit related to computer system integrity, validation, and management support issues. This article provides audit strategies to assist the quality assurance audit team with planning for an effective audit, and accurately assessing data quality, data integrity, and good computer validation practices for new electronic systems. Key Words: Electronic system; Data quality; Data integrity; Good computer validation practices; Quality assurance audits
INTRODUCTION GCP ELECTRONIC SYSTEMS are present throughout all phases of the modem clinical research process. This evolving paradigm is focused on performing clinical research more efficiently and effectively by reducing the cycle time for new drug development, improving consistency and accuracy of GCP data, and introducing electronic systems at the earliest phases of clinical studies (1,2), that is, these efforts aim to speed up data collection throughout the product development cycle. New electronic systems are de-
Presented at the DIA “Advanced GCP Workshop: New Techniques,” September 15-17, 1997. Philadelphia, Pennsylvania. Reprint address: William Stinchcomb, D44F AP34, Abbott Laboratories. Abbott Park, IL 60064.
veloped at an accelerated pace as changes in computing technology allow for increased flexibility in data collecting, processing, and communications. As these new systems are introduced in greater numbers, configurations, and complexity, new challenges in compliance assessment are generated for quality assurance (QA) compliance auditors. The challenges include assessing electronic system integrity for data quality, adequacy of the available documentation, and developing an increased skill and comfort level when auditing new systems. This article provides a guidance for the QA audit team for defining the electronic system, offering audit planning tips to assure a successful audit, and rationale for communicating appropriate credit during the
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