What are the Challenges of Paper-based Instrument Validation?
Paperless Equipment Validation Software Offers Unique Benefits
End-to-end solution: ValGenesis enables you to fully automate the entire equipment and analytical instrument lifecycle from validation planning to decommissioning/retirement in one easy-to-use system.
Part-11 compliant features: Our equipment validation software solution provides a time-stamped audit trail, reporting, and electronic signature capabilities that fully satisfy FDA 21 CFR Part 11 requirements. If an added level of security is desired, it can also enforce signature verification. Our solution is also compliant with EU Annex 11, GAMP 5 and ASTM E2500.
Increased audit-readiness: Our VLMS is 100% paperless. Because it eliminates virtually all time-consuming, error-prone manual activities (e.g., printing, scanning and routing documents) users enjoy a high degree of data integrity. Timely collection of data means you’re always ready for internal and external audits.
Reduced risk: The solution promotes a risk-based approach to equipment and instrument validation by enabling you to design workflows and decision trees that fully automate precise protocol generation.
Electronic protocol execution: This functionality allows you to execute protocols from authorized laptops or tablets with or without network/internet connections.
Deviations workflows: Execution failures can be easily managed by deviations workflows within the system.
Reduced data collection time: Our VLMS accesses parsed data and associated raw data files directly from your instruments and dynamically collects process parameters from that equipment based on the defined schedules. These innovative functions expedite data collection while ensuring a high level of data integrity.
Log data collection capabilities: Our electronic log module collects log data—including calibration logs, periodic reviews and cleaning/usage logs—during the equipment/instrument lifecycle.
100% paperless: All validation deliverables are electronically created, reviewed and approved. Eliminating paper from the validation process can increase efficiency and prevent costly regulatory delays in getting products to market.
Mobile access: With ValGenesis equipment validation software, 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.
Many life sciences companies are beginning to realize the advantages of digitizing their equipment and instrument validation methods with ValGenesis' feature-rich solution. Features include:
• Risk-assessments powered by decision-tree logic
• Electronic execution of log records
• Equipment register management
• Deviation management
• Automatic task notification, schedules, and nudging features with email
• Electronic protocol execution
• Dynamic electronic traceability matrix generation
• Template-driven document authoring to ensure consistent, compliant documentation
• Integrated close-looped equipment and instrument lifecycle management
• 21 CFR Part 11-compliant features like time-stamped audit trails, reporting, and electronic signature capabilities
Ready to join the digital validation revolution?
Save time and money while streamlining your equipment and instrument validation processes with our paperless, risk-based 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."