AuditTrail.Net – Records-Management & Compliance. AuditTrail.Net allows you to track all the changes made within your CAQ system. A separate 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.
- 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 and change to the database within your CAQ system – during and after said action is performed. 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. The user of the software has no way of circumventing these measures – not even if he tries to gain access to the database manually.
AuditTrail.Net facilitates successful compliance management, a factor that is of increasing importance in the light of strict data safety and company regulations. It gives you everything you need in order to be able to ensure that changes made to data in all your CAQ.Net® modules are documented correctly and recorded in an unalterable data vault.
Our individualized user-rights management increases overall transparency in your company, as all users can inform themselves with respect to the most recent changes made to data. The seamless change tracking, for instance, allows you to find out immediately who changed a comment regarding a supplier complaint, what failure cause was initially entered, or who sent a report to a customer when. All business relevant information is flawlessly documented in AuditTrail.Net. This means that you can comprehensively fulfil the requirements for electronically stored data as postulated by the regulatory authorities with regard to the change from paper-based records to a computerized system.
Prerequisite in the Field of Medical Technology and Pharmaceuticals
Manufacturers and suppliers of medical technology and pharmaceuticals must adhere to the strict rules and regulations of the European Medical Device Directive and the US Food and Drug Administration (FDA). This is why during the development of AuditTrail.Net, special attention was paid to the medical and pharmaceutical regulations stipulated by the GxP, FDA or ICH and formulated in standards and guidelines such as ISO 13485, 21 CFR 820, ISO 14971, GMP, GLP, GCP, or 21 CFR Part 11. All of this allows you to conduct comprehensive compliance management with a well-structured and easily usable software solution that ensures adherence to internal and legal obligations.