(Re-)validation and support during audit preparation

At the start of the project, the audit-relevant processes, systems for automated data processing, and work instructions (SOPs) and associated documentation are reviewed and checked. The focus is on the established and documented processes and systems, as well as the existing IQ, OQ and PQ validation protocols. Changes, deviations or gaps such as insufficient documentation (e.g. VBA code); non-validated systems or components; deviations from standard and base technologies (e.g. non-compatible audit trails); insufficient monitoring of changes and configuration management; insufficient user rights (authentication and authorization) and information security (confidentiality, availability and integrity); missing training documentation or lack of training, as well as inadequate security guidelines are documented, evaluated, transferred to the regulated change management process, implemented and revalidated, if necessary.