Audit-Trail for your CAQ-software. 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.
- Comprehensive evaluation methods
- Read-only display of history right next to the actual data
- Uninterrupted recording and saving of changes made to records
- Traceability of changes in shape of protocols and audit-trails
- Individual rights management
- Supports compliance measures
- Safeguards record inalterability
- Seamless documentation of changes from initial creation to final deletion
- Individual labelling of vital records
- Creation of change history for subsequent audits
- Simplified data restoration process in case of hardware failure
- Realization of medical and pharmaceutical requirements stipulated by the GxP, FDA, MDR, or ICH
- Compliance with rules and regulations such as ISO 13485, 21 CFR 820, ISO 14971, GMP, GLP, GCP, or 21 CFR Part 11
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. This way you can always ensure accountability and transparency with regard to changes made to data, the deletion of files, and the manipulation of documents, reports, and any other type of file.
Every change that is made to a record or database field is recorded in a separate structure. This safeguards complete traceability in your libraries and other database entities and ensures that changes made to data in all your CAQ.Net® modules are documented and recorded in an unalterable data vault. Users of the software have no way of circumventing these measures – not even if they try to gain access to the database manually.
Transparency & Rights Management
The comprehensive user-rights management system allows you to specify who can inform themselves with respect to changes made to data. Either the AuditTrail.Net module itself can be used to evaluate and view the change log, or, alternatively, users can view the respective change history for each individual data record on a separate tab directly in the applicable module.
The seamless change tracking in AuditTrail.Net facilitates full transparency, as it allows you to e.g. find out immediately who changed a comment regarding a supplier complaint, what failure cause was initially entered, or what changes were made to an inspection plan. This means that you can comprehensively fulfil the requirements for electronically stored data as postulated by the regulatory authorities with regard to the switch from paper-based records to a computerized system.
You might also be interested in the following: