SoftExpert Incident is a software that ensures that product and process issues are properly and efficiently handled through an integrated process that tracks and manages the complete incident lifecycle from the initial report through investigation, root cause analysis, resulting actions (CAPA) and follow- up verification of effectiveness.
SoftExpert incident management solution establishes a standard system for incident intake and automates incident management activities facilitating collaboration on incidents and tracking the progress of investigations.
The system is aligned with key elements of the major frameworks such as ISO, FDA and ITIL. However, configurable workflows, forms, and business rules mean that the system can be set up to match the organization’s unique requirements. Some applications may include:
- Incidents related to IT system anomalies and information security.
- Nonconformances related to incoming materials, components, parts, and finished products.
- Deviations in manufacturing processes.
- Variances in performance management.
- Near-misses to help identify and mitigate potential problems and systemic risks.
- Loss events.
- Break in the compliance to the law, policy, procedure, licensing or standards.
- Environmental accidents and workplace injury/illness.