CAPA Management
Centralized Tracking & Trending of Incidents, Deviations & Corrective Actions
CAPA Connect is an integrated deviation, incident and corrective and preventative action management software solution which allows you to manage all of your quality events in one central location. CAPA Connect has intuitive forms and workflows which adapt based on the type of quality event being managed. It also provides the ability to centrally manage root causes and corrective and preventive actions to ensure efficient and complete execution of CAPA plans. Integrated metrics and reporting and powerful view technologies allow you to drill into events to get a better understanding of the bigger picture.
Proactively mitigate quality risks and strengthen CAPAs
Life Science organizations that are governed by GxP requirements and ISO standards are required to create and manage Corrective Actions/Preventative Actions (CAPA’s) as a result of observations and information gathered during audits, inspections, customer complaints, deviations and customer feedback. Investigating and correcting quality issues is key to enhancing product quality, safety and customer satisfaction and achieving regulatory compliance. When implemented effectively, CAPA Management Systems can transform the quality environment, aligning corrective action plans with the source issue, and thus lowering the chance of recurrence.
Perfect For
Pharmaceutical Organizations
Contract Research Organizations
Manufacturing Organizations
Built To
Report & Track Quality Events
Plan and Coordinate Clinical Deviations
Facilitate CAPA Management
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A Closed Loop Approach to Quality & Clinical Events
Report Incident
Our online form allows both internal and external users to report planned and unplanned deviations or incidents as they happen
Incident Outcome
Workflows ensure that deviations and incidents are properly analysed and that any actions taken are adequately recorded
Initiate Corrective Action
Once QA has reviewed a deviation or incident that can decide to raise a CAPA if required or associate the issue to an existing CAPA
Preventative Action
If a CAPA is raised, a more detailed root cause analysis and corrective or preventative action plan can be defined and implemented
Report & Track Incidents and Deviations
Intelligent Forms
Our intelligent incident form automatically adapts to the type of incident and guides users on the information that they need to provide
Smart Workflow
Our integrated workflow engine routes the incident to the appropriate individuals for investigation and closure
Add Attachments
Attachments can be added directly into the incident form to allow the upload of supporting evidence or documentation
Transparency & Traceability
Improved transparency and traceability are possible through structured incident data and strong reporting capabilities
From Investigation to Corrective Action
Automatic Investigation Tasks
Investigation tasks can be automatically allocated to relevant groups based on the type of incident
Root Cause Analysis
Root cause analysis can be carried out directly in the CAPA form and multiple causes can be defined. Actions can then be directly associated to causes
Facilitate CAPA Planning
Action plans can be devised and allocated to individuals with clear due dates to ensure that CAPAs are executed effectively and efficiently
Metrics & Reporting = Full Quality Oversight
Configurable Dashboards
A multitude of configurable Metrics can be displayed within dashboards to give you measurable insight into your CAPA system
Real-time Visibility
All reports and metrics are based on real-time data so that decisions are always made on the latest information
Monitor Quality System Health
Measure quality system health based on predefined KPIs to ensure that you are operating optimally
Packed Full of Other Functionality
Intelligent forms
Our intuitive forms adapt automatically based on the type of quality event being reported
Task Allocation
Actions are automatically tasked and monitored for completion by the system
Reminders & Notifications
Automated reminders and notifications means that you are able to keep on top of action plans
Dashboards & KPIs
Real-time KPIs and Dashboard give you insight into your quality system
Root Cause Analysis
Root cause analysis is significantly facilitated through our centralized form
Database Integration
Integration with 3rd party data sources for reference data
PDF Engine
Automatic generation of PDF/A records for all incidents and CAPA
Digital Signatures
21 CFR Part 11 compliant digital signatures for final incident and CAPA sign-off
Email Notifications
Automated email notifications for tasks and events directly in your inbox