keep every action traceable
Centralizes incident reporting, investigation and resolution in one controlled lifecycle — from first report through GxP impact assessment to audit-ready closure.
Teams can capture incidents from internal or external sources, categorize by priority, assign investigation owners and track resolution actions with due dates. Built-in communication keeps reporters informed throughout. Incidents link directly to affected systems, requirements, designs, tests, changes and deviations. GxP-relevant events escalate seamlessly into Deviation or Change workflows. Every incident closes with supporting evidence, eSignature and a complete audit trail.
GxP Impact Assessment & Escalation
Assess the GxP relevance of every incident and escalate quality-impacting events directly into Deviation, Change or CAPA workflows. Validfor ensures that no incident with regulatory significance falls outside the controlled quality lifecycle.
Traceable Investigation & Closure
Connect incidents to the systems, validation records and documents they affect. Every investigation note, action item, diagnostic finding and resolution is captured in full, closed with eSignature and retained as structured, inspection-ready evidence.
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bigger impact.
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Frequently Asked Questions
How does Validfor's Change Module streamline the change control process?
Can I customize the change request workflow in Validfor?
Yes, Validfor allows you to customize the change request workflow to match your organization’s specific needs. You can define different approval levels, assign roles and responsibilities.
How does Validfor ensure traceability in change management?
Validfor ensures traceability by automatically linking change requests to related documents, such as requirements, designs, and tests. Any changes made to these linked documents are automatically reflected in the change request, providing complete visibility and control over the impact of changes.
How does Validfor handle emergency changes?
Validfor allows you to define and manage emergency change requests with expedited workflows and approvals, ensuring that critical changes are implemented quickly and safely.
Can I track the history of changes made to a system in Validfor?
Yes, Validfor maintains a complete history of all changes made to a system, including who made the change, what was changed, and when it was changed. This provides full transparency and auditability.
How does Validfor support impact assessment for changes?
Validfor provides a structured framework for conducting impact assessments, allowing you to evaluate the potential impact of changes on various aspects, such as GxP, product quality, and patient safety.
How does Validfor support electronic signatures for change requests?
Validfor integrates electronic signature capabilities, allowing authorized users to electronically sign change requests and related documents, ensuring compliance with 21 CFR Part 11 requirements.
Can I generate reports on change management activities in Validfor?
Yes, Validfor provides customizable reports on change management activities, allowing you to track key metrics, identify trends, and demonstrate compliance.
