We help life sciences companies enforce validation standardisation across their supply chains. Increasing regulatory pressure demands rigorous efforts to maintain validation status while optimising internal resources. We believe that digitalising the validation lifecycle with VLMS from ValGenesis is premier solution for achieving these goals without compromising documentation quality and integrity.
This industry leading solution, trusted by trusted by more than half the world’s top 50 life science customers, is the first 100% paperless validation lifecycle management system. VLMS is a 21 CFR Part 11 compliant SaaS solution, with every update and system core validated by ValGenesis for continuous compliance and reliability. By choosing VLMS, your organisation can enhance audit success through efficient and streamlined validation processes, thereby reducing burdens consistently.
Eradicate data integrity flaws derived from paper-based tasks by using a data integrity by design application
Homogenise your validation procedures across your global organisation
Optimises teams’ resources by reducing validation time by half.
Simplify validation documentation review and approval workflows
Get full and instant visibility of the validation state of compliance
Streamlined processes to effortlessly succeed in audits
In December 2023, our implementation went live with ValGenesis VLMS in our Consultancy division to ‘Rephine’ our processes.
With our experts fully engaged in this system, we actively support your business’s digitalisation journey through a new business line, aiming to elevate and revolutionise your path to digital excellence.
Our streamlined processes, including Computer System Validation (CSV)
and Equipment Qualification, boost project management efficiency.
We reduce time spent on documentation review and validation testing
activities while addressing data integrity concerns
Our expert consultants can implement your VLMS and configure your processes to achieve validation best practices. System validation and people training as additional services to ensure the success of the implementation project.
As a ValGenesis CoE (Center of Exellence), Rephine host a VLMS instance. This allows us to gain access to your preconfigured and isolated site easily within Rephine’s VLMS to manage.
Allow Rephine to create comprehensive digital validation documentation for you, leveraging our validation expertise alongside Rephine’s VLMS capabilities to meet all your validation requirements.
Relieve yourself of the burden of maintaining validation status for your GxP assets. Rephine manages initial validation and all subsequent activities, providing online access to documentation via Rephine’s VLMS.
Juan Torrijos is a Senior GxP Compliance Consultant and Auditor at Rephine with over 15 years of experience in the life science industry. Throughout his career he has led Computer Systems Validation (CSV), Data Integrity, and internal audit projects in regulated environments, as well as the design and implementation of remediation plans and GxP training programs. He also partners with pharmaceutical and biotechnology companies to digitalize their validation processes, helping them move away from paper-based systems toward more efficient and inspection-ready approaches.
Our Digitalisation experts can provide ongoing assistance with customisable CSV systems, regulatory consultancy, and more, to help with your QA journey.
Discover our other Digitalisation services and how are experts can help you.
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Article We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.
Explore our extensive GMP audit library to see the range and scope of live reports we have in stock, join a live audit, or commission a bespoke audit
Maintain high standards of life sciences manufacturing supplier qualifications and GMP auditing within the supply chain through our expertise
Discover how we can help your product reach to market, fully and demonstrably complying with the latest GxP standards
From data integrity to implementing new systems, our experienced team with a digital mindset, can lead you to transformative achievements
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REPHINE INDIA
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