Audit Trail – Data Collection and Validation

Seamless recording
of changes

Comprehensive
rights concept

Fulfillment of industry-specific
requirements

Traceability of all Changes

Data Validation, Change Tracking, and Traceability: AuditTrail.Net allows you to track all the changes made within your CAQ system. An independent, specially protected structure is used in order to record the date/time, username and workstation when changes are made. This allows you to precisely identify, when who made what changes where. Hence, the fulfilment of all relevant documentation duties takes place in the background, and, at the click of button, you can immediately receive all e.g. audit-relevant change information as stipulated by applicable standards and regulations.

AuditTrail.Net allows you to document every single access to records or change to the database within your CAQ system and, upon activation, becomes an integral part of the software.

Functions of Audit Trail



Simple visualization & filter function
Readable visualization of the history directly with the actual data or filterable in the Audittrail.Net module itself.
Individual rights assignment
Control who can view the change log in detail via a comprehensive rights concept.
Complete documentation of record processing
Software users have no possibility of bypassing the protocol, not even when accessing the database manually.
Implementation of medical technology and pharmaceutical requirements according to GxP, FDA or ICH
Compliance with the requirements for electronically stored data demanded by regulatory authorities when paper processes are replaced by computerized systems.
Compliance with standards and guidelines
Support in complying with standards and guidelines, such as ISO 13485, 21 CFR 820, DIN EN ISO 14971, GMP, GLP, GCP or 21 CFR Part 11.