What are the Challenges of Paper-based CQV?
Paperless Facility CQV and Equipment CQV Offers Many Benefits
Complete system: Our system provides a complete genealogy from CQV to operational qualification (OQ) / performance qualification (PQ) and enables reusability of the contents used in CQV for all lifecycle deliverables.
Integrates with other systems: The solution integrates with familiar enterprise systems like SAP and others to pull asset information and other related data. ValGenesis also offers an application programming interface (API) stack that you can use to integrate systems yourself, even sharing data bi-directionally.
Risk-based approach: Unlike manual, paper-based systems, ValGenesis allows SMEs to perform a risk-based commissioning and qualification process that identifies both directly and indirectly impacted systems, as per approved protocols, SOPs and processes. You can also conduct design reviews with a risk assessment to ensure critical requirements are factored into the design. Since the foundation for successful CQV is laid during design, this is a crucial advantage.
Minimizes deviations: The solution allows you to develop a risk-based strategy for all testing and documentation requirements, whether it's an entire system or a single piece of equipment. All stakeholders can approve the strategy to minimize deviations. What's more, you can track and manage the disposition of all deviations using best practice electronic work processes.
Increases audit-readiness: Because the ValGenesis VLMS eliminates virtually all time-consuming, error-prone manual activities (e.g., printing, scanning, and routing documents), users are assured a high degree of data integrity. Timely collection of data also means you're always ready for internal and external audits.
Improve Your CQV Process with These Unique Features
With ValGenesis VLMS maintaining your organization's equipment and facility CQV processes, you'll enjoy a host of robust features and functions, including:
- Assessments powered by decision-tree logic
- GxP asset management with real-time validation status
- Quality gate checks for commissioning activities
- Applied critical thinking with procedural risk assessments at a system and function level
- Automatic task notification, schedules, and nudging features with email
- Integrated close-looped CQV lifecycle management
- Templates that can be enforced with required sections and system requirements
- Validated connectors for enterprise systems
- Workflow process automation to reduce commissioning efforts
- Paperless test execution with integrated deviations management
- Design review
- Automated trace matrix generation
- Real-time collaboration with remote and distributed teams
- 21 CFR Part 11-compliant features like time-stamped audit trails, reporting, and electronic signature capabilities
Ready to join the digital validation revolution?
Boost productivity and reduce compliance risk with our paperless CQV 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."