COMPLIANCE GROUP INC:
EMPOWERING DIGITAL VALIDATION EXCELLENCE WITH VALGENESIS PARTNERSHIP
Compliance is the foundation of trust, bridging innovation and excellence while unlocking efficiency and operational success in regulated industries like Life Sciences and Medical Devices.
At CG, we are committed to empowering organizations in the Life Sciences, Healthcare, and MedTech industries with innovative solutions that streamline operations and ensure compliance excellence. Our partnership with ValGenesis, a global leader in digital validation lifecycle management, allows us to deliver solutions that drive efficiency, reduce risks, and foster growth in a highly regulated environment.
ABOUT VALGENESIS
ValGenesis, Inc. is the creator of an innovative software platform that serves as a foundation for managing compliance-based validation activities in life science companies. Fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements, ValGenesis VLMS replaces traditional, manual methods with a fully paperless, digitized solution.
By streamlining workflows, improving operational efficiency, and ensuring compliance, ValGenesis VLMS redefines enterprise-level validation management. This pioneering platform empowers life sciences companies to achieve seamless, paperless validation. As the first-of-its-kind, ValGenesis VLMS drives productivity, regulatory excellence, and risk-based validation, setting a new benchmark for compliance and operational success in the industry.
CORE FEATURES OF VALGENESIS VLMS
- Paperless Risk-Based Validation: Eliminate inefficiencies and errors from manual processes while focusing resources on high-risk areas to optimize efforts and reduce cycle times.
- Seamless Integration: Connect ValGenesis VLMS with existing ERP, MES, and QMS systems for a unified ecosystem.
- Centralized Validation Platform: Streamline validation processes by eliminating fragmented data silos with a unified platform.
- PDF-Based Validation: Conduct validation activities seamlessly using PDF documents, including vendor-provided files.
- AI-Driven Insights: Leverage intelligent analytics to enhance operational efficiency and optimize validation activities.
- Real-Time Traceability: Automatically generate traceability matrices by linking requirements and documentation in real time.
- Comprehensive Audit Trails: Ensure adherence to ALCOA+ principles with a secure and immutable record of all activities.
- Part 11-Compliant Signatures: Approve and execute documentation using electronic signatures that meet regulatory compliance.
- Ready for CSA: Implement risk-based requirements and conduct both automated and unscripted testing with ease.
- Agile-Optimized Solutions: Adapt quickly to changing needs with software designed to support agile workflows.
- Offline Validation Capabilities: Use mobile tools to perform key validation tasks offline, ensuring timely evidence capture.
- Scheduled Reviews and Tasks: Maintain compliance with dynamic review schedules and task management tools.
- Controlled Change Management: Evaluate and verify updates to validation deliverables to maintain compliance and system integrity.
- Detailed Reporting Tools: Generate automated or on-demand reports to track and monitor validation activities effectively.
WHY CG WITH VALGENESIS?
CG partners with ValGenesis to deliver end-to-end digital validation solutions, redefining how organizations manage their validation lifecycle. By integrating ValGenesis’s innovative Validation Lifecycle Management System (VLMS) into a comprehensive strategy, we address the entire product lifecycle from R&D and manufacturing to distribution and post-market surveillance.
CG stands as your trusted partner in navigating this digital shift, ensuring seamless integration of solutions tailored to your operational and regulatory needs. Our collaboration reflects a shared vision of advancing digital validation in the life sciences sector. Together, we provide organizations with robust, scalable, and fully digital validation systems that meet the rigorous demands of regulatory bodies worldwide.
KEY BENEFITS OF OUR PARTNERSHIP:
- Automated Validation Processes: Reduce manual effort, streamline workflows, and enhance accuracy.
- Data Integrity: Ensure secure and compliant data management across systems.
- Real-Time Collaboration: Enable cross-functional teams to collaborate seamlessly in a centralized digital environment.
In industries governed by stringent regulations, non-compliance can be costly. Our solutions align with evolving regulatory standards, ensuring you are always audit-ready and compliant. Also,
- Stay compliant with FDA’s (Food and Drug Administration) CSA (Computer Software Assurance) guidance and standards.
- Meet global expectations for electronic signatures and data management.
- Take advantage of our expertise to navigate regulatory challenges with confidence.
CG understands that no two organizations are alike. Whether you’re a MedTech startup or a global pharmaceutical leader, we tailor to your specific needs, ensuring scalability and flexibility as your business evolves.
We don’t just implement ValGenesis VLMS—we partner with you at every stage of your validation journey, from assessment and planning to deployment and optimization.
At CG, we prioritize our clients’ success. Our dedicated team ensures that every solution we implement aligns with your unique goals, regulatory requirements, and operational demands.
WHAT SETS CG APART
- Achieve real-time validation management
- Minimize errors and enhance operational transparency
- Improve collaboration among cross-functional teams
- Seamless integration of ValGenesis solutions into your operations
- Deep regulatory knowledge combined with technical expertise
- Ensure readiness for audits and inspections
- Staying compliant with evolving regulations through industry expert guidance
- Digitized validation approach reduces product development cycles
- Stay competitive in fast-paced industries like Life Sciences and Healthcare
READY TO TRANSFORM AND DIGITALIZE YOUR
VALIDATION PROCESSES?
CG is your trusted partner in digital validation. With our expertise and ValGenesis’s innovative technology, we empower organizations to achieve compliance excellence, enhance efficiency, and stay ahead in competitive markets.