Change Control Management
Take Charge of Your Change Control Process
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.
Manage complete change control and strengthen quality
Do you know how to properly manage and control your change control documentation so that you can pass your next audit? Life science organizations that are governed by GxP requirements and ISO standards are required to observe change control management at the core of quality processes.
With Change Connect, an automated workflow process notifies and assigns necessary reviewers and approvers by predefined rules. Once a change control is approved, the form is automatically advanced to the next stage, so change requests are completed in a timely manner and your study moves forward.
Perfect For
Pharmaceutical Organizations
Contract Research Organizations
Manufacturing Organizations
Built To
Measure the impact of change in your system across functions
Execute change with clearly defined roles & responsibilities
Improve transparency and traceability with strong reporting capabilities
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An End-to-End Approach for Change Control Management
With Change Connect, you can track, manage, monitor, and control action items from beginning to end.
Change Initiation and Planning
A Change Requester can initiate and assign a change, while the Change Owner can make an action plan.
Change Plan Approval
The Change Form received can be approved for completeness and either approved or rejected. Multiple reviewers can perform their approvals in parallel, reducing cycle time.
Change Plan Execution
The Approved Change Plan is received by an Action assignee and can be amended and submitted for approval. When all actions are marked complete, the Change Owner initiates the implementation.
Change Closeout
The implementation of the change is approved and a PDF record is filed in the Record Center.
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
Change Control Software Packed With Powerful Functionalities
Compliant Digital Signatures
Our solution comes prefaced with a compliant digital signature tool
Adding Attachments
Add attachments to the change form that will be combined into the final PDF
Permission Access
Depending on permissions based on user groups, you will be able to securely access specific content.
Audit Trail Capture
See the entire history of the change form status, who was tasked to review and when the request was completed.
Intelligent forms
Our intuitive forms adapt automatically based on the type of quality event being reported
Smart Workflow
Our integrated workflow engine routes the change request to the appropriate individuals for review and closure.