Merck Healthcare KGaA, Germany
Aurélie Delaunay works for Merck Healthcare, in Darmstadt Germany as Quality Strategy Lead for Data Integrity within the Biopharma Research and Development Quality department, being in charge to develop and implement the strategy for data integrity. She is responsible for addressing improvements to electronic data processing, including data creation, handling, transfer, storage and archiving via collaboration with the systems validation and business process teams. She has set-up and implemented global data integrity process audits to assess compliance to data integrity guidelines across the R&D department. She has delivered training and knowledge sharing sessions for auditors to support data integrity approaches and audit trail review during audits; and develop a standard to support data reliability and compliance with electronic data requirements.
She has more than 18 years of experience in clinical research/drug development. After graduating with a Master’s degree in Oncology from Paris University in 2001, she worked as a CRA within IQVIA before joining its QA department as a GCP Auditor in 2007, being in charge of auditing investigator sites, vendors and internal processes, and hosting sponsor audits and regulatory inspections. Aurélie developed to the global QA Lead role being responsible to oversee quality aspects of sponsor clinical trial programs within a strategic partnership.
Audit Trail Review During Audits – Practical Aspects
Since clinical research was digitalised, the controls that used to exist in a paper environment should continue to be preserved in a digital environment.
One important component to ensure data integrity, is the ability to reconstruct the clinical trial activities which were conducted to create, process, maintain and archive all the data subject to regulatory authorities’ scrutiny. Traceability was immediately visible to a document reader in a paper environment. In a digital environment, this is covered by the system audit trails.
Audit trails provide relevant information that requires to be reviewed during GCP audits. Unfortunately, this was not always sufficiently leveraged in the past. Audit trails should be requested as a routine practice during audits, and their review part of the standard scope of GCP audits.
The presentation will review the practical aspects of accessing and reviewing audit trails by auditors, including