Validation Lifecycle Management System
ValGenesis VLMS is the industry standard digital validation platform for life sciences worldwide. Peerless in capability, it empowers you to enforce standardization, ensure data integrity, reduce risk, lower the cost of quality, and strengthen your compliance posture.
The Most Complete Validation System
- Single source of truth across your GMP operation with a holistic view of the entire validation lifecycle
- Highly configurable with module-based deployment
- Multi-site scalability, multi-lingual ready
- Delivers increased speed and efficiency to every validation activity
Ready for Every Validation Process
Meet cGMP requirements and maintain a state of continuous compliance.
CSV and CSA
Apply a risk-based approach and reduce overtesting for shorter cycle times.
Guarantee the accuracy and auditability of your equipment and instruments.
Eliminate silos with seamless connectivity across process, data, and knowledge management.
Prove your analytical methods are robust, reproducible, and fit for their intended use.
Establish controls and reduce error and risk at each stage of the cleaning process.
Establish Control and Minimize Risk
Leverage a single source of truth for all validation activities and supporting documentation
- Apply a risk-based approach with assessments at the requirement, functional, or system level to determine the proper level of validation required
- Enforce standardized protocol templates and testing requirements based on the risk profile
- Automate authoring with decision tree assessments
- Support any change control process workflow by change type through process maps
- Eliminate guesswork with dynamically updated traceability matrices
Introduce critical thinking into your validation plan for faster, more confident decision-making
- Employ a least burdensome approach, focusing your testing on mid- to high-risk requirements
- Divide and conquer with online collaboration and split execution
- Implement agile, waterfall, linear, or other validation methods as your business requires
- Integrate with third-party applications to streamline development, testing, and business operations
Build Your Case for Quality
Implement high-quality processes that lead to high-quality products, reducing your risk of defects or recalls
- Improve regulatory compliance by executing quality processes
- Facilitate quality by review (QbR) with standardization, preapproved workflows, and easily accessible audit trail metadata
- Eliminate subjectivity with controlled processes, configurable risk models, and standardized validation deliverables
- Create and enforce technical controls to minimize inconsistencies and human error
Always Be Improving
Monitor changes to systems and validation deliverables to identify problematic systems and areas for improvement
- Capture data for business intelligence and analytics
- Generate reports and export data for time-motion analysis
- Create dashboards and metrics to keep your finger on the pulse of validation
- Continuously assess the status of a system's validated state through periodic reviews
- Establish a data lake as a source for artificial intelligence (AI) and machine learning (ML)
What's New in VLMS v4.2?
New: Design Manager Module
- First-to-market CSA-ready solution, providing risk assessment at the requirement level to reduce overtesting common in CSV.
- Supports agile methodology with backlog, sprint, testing, and release management.
Unifies validation data into a single source of truth that aligns validation and development cycles to follow the SOPs of SDLC.
- Read the press release.
Execution With PDF Documents
Execute and reuse vendor documents and tests, saving time with original source documents.
Upload piping and instrumentation diagrams (P&IDs), map P&ID locations during authoring, and leverage P&ID files as objective evidence.
Enhanced e-Logbook Integration
Seamlessly navigate between VLMS and e-Logbook and pull entities created in VLMS for log capture.
100+ Useful New Features and Enhancements
- Dynamically add external users for review/approval/verification activities
- Collaborate virtually on authoring documents
- Transfer entities and associated documents/objects from one category to another within the site
- Configure deviation initiation (protocol error) within execution steps, further enforcing standards
- Capture screens in more robust ways during execution
—PLUS more than 100 other features and enhancements to improve user experience, performance, and stability
ValGenesis VLMS Drives Leaps in Productivity
Authoring, executing, and approving validation protocols
Creating and maintaining traceability matrices
Performing, reviewing, and approving risk assessments
Tracking validation status
Preparing for audits and inspections
And Real Benefits Across the GxP Organization
- Apply agile methodologies to validation
- Asses risk at the requirements level
- Enforce consistent results
- Capture objective evidence directly in the protocol
- Speed approvals with automated routing and GxP-compliant e-signatures
- Manage test failures via predefined workflows
- Produce clear, precise time-stamped audit trails
- Enforce correct template usage — every time, at all sites
- Avoid tedious recreations of requirements traceability matrices
- Ensure ALCOA+ data integrity
- Deploy technical controls to enforce SOPs
- Eliminate illegible handwriting and encourage GDocP
- Initiate and perform quality by review (QbR)
- Cut system management burden with a cloud-based system
- Standardize all validation activities with a unified platform
- Keep information and processes secure
- Implement your backup, disaster recovery, and business continuity plans
- Extend your single sign-on (SSO) identity management system
- Perform forensic analysis of data
- Avoid observations, warning letters, and consent decrees
- Reallocate staff time and budget to value-added activities
- Get to market faster by reducing validation cycles by > 50%
- Attract a modern workforce with best-in-class digital tools
- Rest assured that regulatory requirements are adhered to
ValGenesis VLMS is a good system that has tremendously reduced manual work. It is contemporaneous, easy to execute, and we can quickly access executed documents. More importantly, it has improved compliance through system-driven interlocks.
Head of Quality for Digital Transformation & Compliance
Enabling the bind functionality and global template management has helped us make tremendous strides toward standardization and harmonization. From a statistical point of view, it has reduced the overall authoring time of deliverables by around 30-70%.
Satish Kumar Shanmugam
IT Product Manager
We saw the benefits almost overnight. As we continue to integrate legacy documentation into the system, we're seeing more and more benefits.
Business Application Manager
In my experience, ValGenesis is unique in that they are willing to share their validation documentation with us. Being able to use this vendor documentation saved at least six weeks off our schedule; that was a tremendous help. We've had a long working relationship with ValGenesis, and they have really taken an interest in our success.
Head of Non-Product System Software Validation Process Management
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