Complaint Handling

• Issue capture, complaint prioritization, investigation, reporting, coding, trending

Audit Management

• Tracking of findings, investigations, resolutions, creation of audit checklists

Nonconforming Materials

• Identification, tracking, and dispositioning of materials, MRB reviews, tag creation, coding, trending

CAPA

• Corrective, preventive and continuous improvement requests, prioritization and backlog management, detailed root-cause analysis, action plan management, short and long-term verification

Design Control

• Tracking of inputs, outputs, verification and validation protocols, reviews, DHF, DMR

Document Control

• Change impact assessment, online approvals, verification of change implementation

Training

• Detailed tracking of user training requirements, history of training and certifications, measurement of training effectiveness, integrated with document change process, management of common training profiles

Equipment Management

• Define, track and manage equipment activities and schedules. Manage defined calibration, maintenance and qualification activities, and unplanned (ad hoc, repair) events.