HAMBURG, Germany—Defects on pharmaceutical print products can put patients’ lives in jeopardy and expose pharmaceutical companies to a high liability risk. 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 pharmacists perform automated and safe packaging quality controls. EyeC software takes into account the newest requirements for data integrity, data security and audit trails. To complete this offer, the German company now launches the EyeC Audit Trail Viewer, a new software that simplifies the preparation and review of audit trailing data.
With the EyeC Audit Trail Viewer, responsible persons can now analyze and document process interventions for auditing in a convenient, controllable and comprehensive way. 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 US FDA Title 21 CFR Part 11. Various filter options enable refining entries to focus on critical events. For instance, the user can search for criteria such as date, user or event type, or use alternative or a combination of search terms. Created search queries can be saved and modified, allowing companies to perform consistent audit trail reviews and save time. Comprehensive reports can also be generated from the reviewed results at any time and used to bring evidence to auditors.
“With the EyeC Audit Trail Viewer, pharmaceutical companies 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.”