Change Module
Streamlines the entire change lifecycle, providing a centralized platform for managing all system modifications. Users can initiate new change requests with customizable unique IDs, categorized by change type, affected systems, and impact assessments. Real-time traceability is ensured through updates to linked documents (requirements, designs, tests) and associated action items.
The system facilitates a structured approval process with pre- and post-approval workflows, ensuring all changes undergo thorough review. Dynamic dashboards offer real-time monitoring of change status, while robust audit trails and electronic signature capabilities guarantee compliance with industry regulations.
Furthermore, integration with other Validfor modules allows for seamless document revision and impact assessment during change implementation.
Seamless Integration
Seamlessly integrates Change Module with all related documentation, including requirements, designs, and tests. All updates to linked items ensure data integrity and facilitate comprehensive impact analysis throughout the change lifecycle.
Comprehensive Impact Assessment
Provides a structured framework for conducting thorough impact assessments, enabling organizations to proactively identify and mitigate potential risks associated with proposed changes. Evaluate effects on GxP, product quality, patient safety, data integrity, and documentation to facilitate informed decision-making and ensure compliance throughout the change lifecycle.
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Frequently Asked Questions
Validfor streamlines change control by providing a centralized platform to manage all change requests, approval workflows, track approvals, and ensure complete traceability. This eliminates manual effort, reduces errors, and accelerates the implementation of changes.
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.
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.
Validfor allows you to define and manage emergency change requests with expedited workflows and approvals, ensuring that critical changes are implemented quickly and safely.
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.
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.
Validfor integrates electronic signature capabilities, allowing authorized users to electronically sign change requests and related documents, ensuring compliance with 21 CFR Part 11 requirements.
Yes, Validfor provides customizable reports on change management activities, allowing you to track key metrics, identify trends, and demonstrate compliance.
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