EyeC (Hamburg, Germany) has launched EyeC Audit Trail Viewer, a new software that simplifies the preparation and review of audit trailing data. The technology allows users “to analyze and document process interventions for auditing in a convenient, controllable and comprehensive way,” said the company. The software enables users to flexibly load and visualize trailing data and provides all the relevant information in a “human-readable format” as required by the U.S. FDA Title 21 CFR Part 11. Various filter options enable the refining of entries to focus on critical events. For instance, the user can search for criteria such as date, user, or even type or use alternative – or a combination of search terms. Users can create search queries that can be saved and modified, allowing companies to perform consistent audit trail reviews and save substantial time. Comprehensive reports can also be generated from the reviewed results at any time and used to bring evidence to auditors.
“Defects on pharmaceutical print products can put patients’ lives in jeopardy and expose pharmaceutical companies to a high liability risk,” said EyeC. “To ensure the quality and transparency of their production processes, pharmaceutical companies must comply with strict legal and normative regulations. Inspection solutions, such as the EyeC Proofiler for print-sample testing, or the EyeC Proofiler Graphic for prepress proofing, ensure that pharmacists perform automated and safe packaging quality controls. EyeC software also takes into account the newest requirements for data integrity, data security and audit trails,” the company added. “With the EyeCAudit Trail Viewer, pharmaceutical companies can ensure the consistency of their audit trail reviews and save valuable time in process control,” said Dr. Ansgar Kaupp, CEO of EyeC GmbH. “Audit trail reviews are now more goal-oriented and therefore faster.”