Untangling the Audit Trail: Tips for Effective Review
Rachel Walker1, David Schumacher1, Staci Loughney1, Rebecca Brainard1
1 Alturas Analytics, Moscow, Idaho
Introduction
Electronic data integrity can only be assured if proper documentation exists within the audit trail for full reconstruction of study events. Some systems include so much or so little information that it can be difficult to determine when a problem or deviation has occurred. Quality assurance professionals can assist with ensuring proper data integrity in a Part 11-compliant system with an effective audit trail review. This poster will outline ways to improve audit trail review, starting with proper validation, progressing to consistent training, and concluding with suggestions of how to approach the review of an audit trail.
About the Presenter
Rachel Walker is an integral part of the Quality Assurance team at Alturas Analytics, Inc. Her focus on improvement of quality systems, attention to detail, and constructive attitude provides confidence that data delivered to our clients meets the highest standards of quality and integrity.
