Configurable change order approvals by employee role and by document type. Notifications to responsible personnel at every stage in the change process. Ability to designate material dispositions for individual documents.
Document Management
Easy access to released and historical versions of documents. Quick viewing of document change history. Tracking of where-used locations and distributed hard copies. Periodic document review notification.
Training
Automated notifications and reminders for training tasks. Easy viewing of redlined and released documents directly from training tasks. One-step inheritance of training requirements for like job titles.
Reporting
Ability to easily create custom reports for any module and export results to Microsoft Excel. Advanced SQL-based reporting also available.
Compliance
CAPA and Complaint modules with automated notifications for due dates, including for MDR/Vigilance reporting. Returned Material and Customer Account modules for linking to Complaints. Audit Finding module.
Production Quality
Lot tracking with ERP integration for linking to related modules, including Nonconforming Material Report and Sterile Run. Supplier Quality with tracking of supplier certification due dates. Equipment management with automation around calibration and preventive maintenance.