Issue Management in Regulated Environments
Managing issues such as nonconformities, exceptions, loss-events, and process deviations is one of the central functions of an organization's quality, compliance and risk management team. Relying on stand-alone niche solutions or paper-based processes to manage issues are ineffective because they fail to address systemic problems due to a lack of broad enterprise reach and visibility. To successfully handle such incidents, managers need a collaboration tool to drive problem resolution since review and remediation activity often spans across departments.
InfoStrength’s Smart Enterprise Suite Issue Management capabilities is a comprehensive solution that enables companies to establish and follow consistent procedures for issue capture, loss event tracking, task management problems, and status reporting. InfoStrength Smart Enterprise Suite supports identification and evaluation of issues as well as case investigation and tracking leading to an elaborate remediation or corrective action process. The powerful analytics and issue reporting functionality give managers complete real-time visibility into the quality and compliance system and provide critical information for reducing the risk of noncompliance.
InfoStrength Smart Enterprise Suite makes a clear distinction between what an issue is and what an incident is. Issues, technically speaking, are associated with either projects or specific tasks of a project. Incidents incorporate a very different work flow that may or may not be associated with a project or a task in a project but instead CAPA, adverse event reporting and perhaps other infrastructure based challenges.
How InfoStrength Smart Enterprise Suite can Benefit You
- Accelerate issue recording, review and resolution approval cycles
- Reduce repeat occurrence with consistent, closed-loop investigation and remedial and corrective action process
- Improve communication and teamwork on exception cases across departments and functional areas
- Gain enterprise-wide visibility into the status of issues and incidents and track related process metrics
Issue Management Features
- Issue Recording:
InfoStrength’s Smart Enterprise Suite Issue Management enables companies to take a risk-based approach to quality and compliance management as companies gain real-time visibility into the quality and document management process and its key performance metrics.
- Investigation and Remedial Actions:
The solution enables triggering automatic alerts and notifications to appropriate personnel for initiating immediate remedial action to contain the impact of the issue and conduct failure investigation to identify the root cause of the failure. Once a corrective action or remediation is initiated, the case remains open till the action plan is carried out and results verified for effectiveness.