Change Control Management 

Take Charge of Your Change Control Process

Quality Connect Quality Management System

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.

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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.  

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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. 

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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

Change Control Software Packed With Powerful Functionalities

Digital Signatures

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 

Ready to get started?

Speak to one of our experts today!

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