Complaint Handling And Regulatory Reporting System Requirements Matrix
Source: AssurX, Inc.
Before you invest in an electronic complaint handling and regulatory reporting software system, make sure to request this document first
Medical Device Companies: Before you invest in an electronic complaint handling and regulatory reporting system, make sure to request this document first! With the help of numerous medical device companies and industry domain experts, AssurX has compiled the most comprehensive requirements matrix for medical device companies. This invaluable document will simplify the requirements and decision-making process for your organization. This document will guide you through every level of requirements including:
- Functional scope
- Intake event
- Investigation and analysis
- Reportability evaluation and regulatory reporting
- Business performance metric and analytics
- Best practice workflows
- Integration with other processes (i.e., audits, capa, etc.)
- Login requirements
- Audit trail, electronic signatures (21 CFR Part 11 requirements)
- Task lists, notification, escalation and reminders
- Configurability of the system