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QuTrack QMS - Incidents Management

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Incident Process Scenario

Incidents occur randomly and can affect the interests of the Business by their nature and outreach. Managing Incidents by providing a system to Report, Investigate and Monitor allows the Enterprise to realize potential risks and address them, thereby avoiding a major impact. It is even more rewarding when managing incidents is automated with an Incident Management Software designed for all Life Sciences companies.

Incident Management Software Solution

This Incident Management Software automates the process of managing incidents across an organization from identification to resolving through investigations, impact assessments, associated CAPA and Closure. This enables an organization to pre-define workflow based on incident type, establish responsibilities to reduce reporting time, evaluate nature of incident with quick access to previous incidents, investigations, associated CAPAs and ultimately reduce the business impact.

The Incident Management Software is designed to provide seamless capabilities in linking the Incidents quality system with critical quality systems such as CAPA, Change Control and others. For example all associated CAPAs originating from incident are initiated and managed for effective closure at CAPA Management.

With configurable workflows and flexible workflow components/ sections it is easy for the Incident Management Software to be transitioned into your current incident handling process within in a short period. Comprehensive Incidents Tracking and Trending v is made available at the click of a button with Summary Reports and Metrics Reports. Incidents Summary Report gives real-time summarized information within the selected incident and incidents metrics reports bring high-level and in-depth performance visibility of closure of incidents across the organization at any given point.

Besides providing best approach for effective closure of incidents, the solution is in total compliance with electronic records and management regulations such as 21 CFR Part 11, by providing audit trails, e-signatures, controlled printing, controlled access, records management and archival in accordance to regulatory standards and policies of an Organization.

VeServ Incident Management Advantage

This Incident Management Software was developed based on extensive research on guidelines from various regulatory agencies, in developing incident management software which is practical and problem oriented with these core benefits:

  • Enterprise wide 24 × 7 accessibility to Incident Management System that allows incident reporting real-time as they happen
  • Automated routing ensures immediate response and corrections
  • Workflow step for qualifying an incident ensures only true incidents are logged and avoids duplication at other quality systems such as deviations
  • Streamlines incident reporting across an organization with central repository for harmonization across multiple sites and increased visibility
  • Live tracking and traceability of Incidents with status, automated alerts and notifications
  • Accelerated Investigations with assignable investigation tasks and root cause analysis tool
  • Improved Incident Closure timelines with best practiced workflows
  • Capabilities to integrate and establish closed-looping with other Quality Systems such as CAPA
  • Customizable workflows to suit your current process
  • Metrics Reports or Trends that are exclusively analytical and visually eye catching

Apart from being an industry standard solution, the system has several key features that enable organization and users to continuously improve the way incidents are handled

Key Features

Simplified Incident Reporting

Incidents of all types can be reported and those that may have an effect on product quality or safety can be captured comprehensively with specifically aligned data fields. By routing to pre-defined individuals such as incident coordinators, the time involved in who to notify and how to respond is drastically reduced resulting in an immediate response.

Investigation & Root Cause Analysis

The Root Cause Analysis allows tasks assignment to the investigators and across the departments based upon criticality of the observation. These investigators in turn can create tasks and send to participants for response. The responses are evaluated for identification of root cause and submitted for CAPA Proposal. Due dates set ensure targeted closure of tasks and auto escalation upon overdue which maintains the nature of the Root Cause Analysis to be robust and effective.

Integrated Quality Systems

The system is designed to be flexible in integrating with other quality systems and establish a seamless and controlled flow between Incident management system and rest of the quality systems specially CAPA Management. The CAPAs originating can be initiated and closed at the CAPA Management with enabled status tracking at the Incident Management.

Automated Alerts & Notifications

This is practical feature that ensures that the users are automatically communicated at defined frequencies and at defined workflow steps about the approaching target date for required actions. Users are notified directly through follow-up e-mails that are sent automatically to the user e-mail account. Besides the system auto escalates the overdue to the concerned authority and help resolve the issue.

Auto Spell

Entered information needs to be described in detail and spelled correctly. The in-built spell check feature ensures all Incidents related information entered into the system is spelled correctly. By auto suggesting and auto correcting with good user interface, users can quickly complete data entry which helps in avoiding repetitions and reduces time spent.

Audit Trails & E-signatures

The trail of the record is tracked and time-stamped providing details of actions performed, at the workflow steps giving in-depth traceability about who performed the action and at what time. Also the system features capturing of the user-consent to the action performed by entering a highly secured and high-level password i.e. e-signature.

Real-time Incidents Reports

Incident Summary Reports that provide real-time summary without opening the record helps personnel holding critical positions to save time by viewing the entire information in one go. Generation of incidents reports on the status of the incidents enables high visibility of the Incidents Management System and Incidents. With eye catching graphical representation, the reports are not only informative but impressive too.

You can feel free to reach us to know more about VeServ Incidents Management System and get your questions answered.

Industries that can benefit from our Solution

  • Pharmaceuticals
  • Biotechnology
  • Biologics
  • Medical Devices
  • Chemical
  • Contract Manufacturing
  • General Manufacturing
  • Food & Beverages