What Are the Challenges of Paper-based Cold Chain Validation?
Automate Cold Chain Validation and Enjoy These Benefits
Complete cold chain validation management: ValGenesis automates the entire validation lifecycle by integrating all stages of cold chain validation, from process design to qualification to continued monitoring against validated limits. The system manages all documents and tasks and connects all critical processes.
Improved regulatory compliance: The solution is fully compliant with FDA 21 CFR part 211.142 and the European Union’s Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 62/03). It dramatically improves efficiency by providing electronic signatures that include time and date stamps as required by FDA 21 CFR Part 11 and EU Annex 11.
Enhanced data integrity: Our VLMS dynamically collects the temperature, humidity and pressure per pre-defined schedules and provides real-time analytics to eliminate human error and provide a high degree of data integrity.
Reduced risk: Effective risk assessment tools help you conduct a risk assessment and mitigation plan for packing design and parameters.
Validation master plan: Our validation master plan template drives all stages of cold chain validation and enforces the required studies and deliverables at every phase with required dependencies between the studies and deliverables.
Internet of Things (IoT) technology: The complexity and significance of cold chain logistics make it a strong use case for IoT platforms and devices. ValGenesis VLMS supports IoT devices to continuously monitor temperature, light, pressure, and humidity, helping you get life-saving medicines to patients quickly and safely. Geopositioning in IoT devices allows you to track devices in transit for added security.
100% paperless: The solution allows you to create, review and approve all validation deliverables electronically. Eliminating paper from the validation process helps you increase efficiency and prevent costly delays in getting products to market.
Mobile access: With ValGenesis, you can access critical documents, complete pending tasks and collect vital data using your tablet or smartphone, extending the benefits of an automated system to the lab, manufacturing floor, or any part of your organization’s facilities.
Manage Your Cold Supply Chain with These Unique Features
Life sciences companies are beginning to realize the cost and time savings of digitizing their cold chain validation efforts with ValGenesis' robust solution. Features include:
- Validation master plan driven by user-defined decision trees, frameworks and templates
- Dynamic electronic traceability matrix generation
- Template-driven document authoring to ensure consistent, compliant documentation
- Electronic execution of log records
- Requirements management
- Automatic task notification, schedules, and nudging features with email
- IoT technology
- Integrated close-looped cold chain validation lifecycle management
- Electronic protocol execution
- 21 CFR Part 11-compliant features like time-stamped audit trails, reporting, and electronic signature capabilities
Ready to join the digital validation revolution?
Ensure the compliance and efficacy of your pharmaceutical cold supply chain with our 100% paperless cold chain validation solution.
"We reduced cycle time more than 50% and gained data integrity in our validation process."
"Validation-related observations dropped 90% after implementation."
"We can easily manage validation deliverables and change requests across global sites with full data integrity."