ValGenesis VLMS 5.0: Next-Gen Validation Lifecycle Management


For 20 years, ValGenesis has been at the forefront of digital validation lifecycle management (VLMS) solutions. Our flagship VLMS platform, the first-ever to secure a patent for paperless validation, established itself as the industry leader, offering an unparalleled depth of features to streamline and manage validation processes within life sciences companies.

With the release of VLMS 5.0, we've ushered in a new era of validation management, seamlessly blending industry-leading functionality with a completely reimagined user experience.

What Makes VLMS 5.0 a Game-Changer?

  • Industry-First AI Innovation: VLMS 5.0 transcends the realm of traditional validation software by harnessing the power of cutting-edge artificial intelligence (AI) to gain new insights across your validation activities.
  • Deeper Regulatory Alignment: Pharma 4.0 demands modern tools to streamline processes and achieve regulatory compliance. ValGenesis 5.0 offers built-in support for emerging regulations, such as the FDA's computer software assurance (CSA) methodology. In fact, VLMS 5.0 is the only CSA-ready validation lifecycle management solution available on the market, supporting both automated and unscripted testing.
  • Prioritizes Both Power and Usability: VLMS 5.0 demonstrates that robust features and a user-friendly interface can go hand in hand. It delivers industry-leading functionalities through a user-centered, intuitive design that emphasizes simplicity and usability. Redesigned workflows guide users through each step of the validation process, while a clean, modern aesthetic ensures a clutter-free environment for maximizing productivity. Speed enhancements and a unified, data-centric platform streamline every facet of your validation activities.

VLMS 5.0 Dashboard with Configurable Analytics and Views

The sleek and customizable dashboard provides a clear view of crucial tasks and reports.

A New Era of Digital Efficiency

The focus on user experience extends beyond aesthetics. VLMS 5.0 represents a significant leap forward in how validation processes are executed and managed. Built to align with agile methodologies, our newest release delivers a comprehensive suite of features and functionalities that empower life sciences companies to optimize validation efficiency and use compliance as a competitive advantage. Here are some highlights:

Standardization: Building Consistency and Confidence

Standardization is the bedrock of a robust validation system. However, achieving consistency across departments and locations can be a challenge. VLMS 5.0 operates as a single source of truth, facilitating cross-functional collaboration and alignment on validation protocols and standardized workflows that enforce compliance and minimize errors and inconsistencies. The result: improved quality and reliability of validation activities at all sites.

Risk Management: A Proactive Approach

Validation is a cornerstone of quality in the life sciences industry. But traditional methods often involve reactive risk management, scrambling to address issues after they arise. VLMS 5.0 flips the script. This next-generation platform integrates risk assessment tools, allowing you to proactively identify and mitigate potential roadblocks. Automated workflows help you monitor and manage deviations. Whether leveraging FMEA, RIM, or custom risk models, VLMS 5.0 is a data-centric system that empowers data-driven decisions to safeguard product quality and patient safety.

Collaboration: Fostering Synergy Across Teams

Validation is a team sport. But communication gaps, disparate systems, and data silos can hinder process velocity. The platform's centralized, data-driven structure engages stakeholders across the organization, ensuring valuable insights are incorporated from the start. Information silos are replaced by a collaborative environment that accelerates decision-making and problem-solving at every level and integrates effortlessly with other enterprise platforms.

Effortless Audit-Readiness: Adhere to ALCOA+ with Ease

Audits can be nerve-wracking. But with VLMS 5.0, you can approach them with confidence. Our comprehensive platform ensures your validation documentation is indexed by its actual information, not just as a repository of unstructured files, keeping data centralized, organized, and accessible. Auditors have real-time access to the information they need, with clear, timestamped audit trails documenting every step of the process. Across our customers, audit prep time is 90% faster with ValGenesis VLMS!

100% Digital: Streamlined Validation Management

Execute validation activities directly from PDFs, including vendor-supplied documents. Use the mobile app to complete key validation tasks offline for contemporaneous evidence capture. Execute and approve documentation faster with Part 11-compliant electronic signatures. Schedule periodic reviews and task reminders to enforce consistency and maintain compliance. VLMS 5.0 optimizes the entire validation process, enhancing efficiency and productivity by eliminating the constraints of traditional paper-based validation methods.

Speed to Market: Deliver Life-Saving Treatments Faster

In the life sciences industry, time is of the essence. Patients are waiting for innovative treatments, and every delay can have life-altering consequences. VLMS 5.0 empowers you to significantly accelerate validation cycle times without compromising quality. Our users, which include 30 of the world's top 50 life sciences companies, report spending:

  • 40% less time authoring, executing, and approving validation protocols
  • 50% less time creating and maintaining traceability matrices
  • 50% less time performing, reviewing, and approving risk assessments
  • 80% less time tracking validation status

The system fosters agility and responsiveness to market demands so you can deliver life-saving treatments to patients faster than ever before.

Embrace the Future of Validation

The life sciences landscape is rapidly evolving, and sticking with outdated methods is a recipe for falling behind. VLMS 5.0 empowers your team with an AI-powered platform that not only meets today's validation challenges but unlocks entirely new possibilities for continuous innovation. Contact us to see how VLMS 5.0 can revolutionize your digital validation processes.


First Look: VLMS 5.0

Get a first look at ValGenesis VLMS 5.0, the latest milestone release of the industry's leading digital validation solution.


Digital Validation

Sophia Vraka

Senior Solutions Engineer

The opinions, information and conclusions contained within this blog should not be construed as conclusive fact, ValGenesis offering advice, nor as an indication of future results.