CAPA Connect for Incidents, Deviations and Corrective & Preventive Actions

Centralized Tracking & Trending of Incidents, Deviations & Corrective Actions

 

CAPA Connect is an integrated deviation, incident and CAPA management solution built with SharePoint, 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.

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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.

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Mitigate Quality Risks and Corrective and Preventive Actions

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 Quality Incident or Deviation

Report Incident

Our online form allows both internal and external users to report planned and unplanned deviations or incidents as they happen

Reviewing Quality Incident or Deviation Outcome

Incident Outcome

Workflows ensure that deviations and incidents are properly analysed and that any actions taken are adequately recorded

Initiate Corrective Action in CAPA Connect

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

Preventive Action in CAPA Connect

Preventive Action

If a CAPA is raised, a more detailed root cause analysis and corrective or preventative action plan can be defined and implemented

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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

Report incidents and quality events electronically

From Investigation to Corrective Action

Initiate Corrective or Preventive action electronically

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

Dashboards and KPIs track health of quality system

Packed Full of Other Functionality

SharePoint infopath electronic forms

Intelligent Forms

Our intuitive forms adapt automatically based on the type of quality event being reported

Workflow tasks automate event escalation steps

Task Allocation

Actions are automatically tasked and monitored for completion by the system

Reminders and Notifications fuel quality processes

Reminders & Notifications

Automated reminders and notifications means that you are able to keep on top of action plans

Real-time dashboards and Key Performance Indicators

Dashboards & KPIs

Real-time KPIs and Dashboard give you insight into your quality system

Analyze Root Causes

Root Cause Analysis

Root cause analysis is significantly facilitated through our centralized form

Integrate with 3rd party source data

Database Integration

Integration with 3rd party data sources for reference data

Automatically PDF event records

PDF Engine

Automatic generation of PDF/A records for all incidents and CAPA

21 CFR Part 11 and Annex 11 Compliant Digital Signatures

Digital Signatures

21 CFR Part 11 compliant digital signatures for final incident and CAPA sign-off

Automated email tasks

Email Notifications

Automated email notifications for tasks and events directly in your inbox

Ready to get started?

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