Ready for Every Validation Process
CQV
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.
Equipment
Guarantee the accuracy and auditability of your equipment and instruments.
Process
Eliminate silos with seamless connectivity across process, data, and knowledge management.
Method
Prove your analytical methods are robust, reproducible, and fit for their intended use.
Cleaning
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
Enforce standardization and achieve consistent documentation with a risk-based approach.
Accelerate Productivity
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
Focus on testing high-risk requirements for maximum efficiency.
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
Establish business rules to assess your risk score and invoke process conditions.
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)
Drill down to real-time validation details for the entire system in just a few clicks.
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.
Rajesh Thempadiyill
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.
Shawn Phillips
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.
Colleen McClenaghan
Head of Non-Product System Software Validation Process Management
See how ValGenesis can support your digital transformation.