ValGenesis
Provider of a software platform for digital validation lifecycle management used in life sciences. The platform centralizes validation planning, authoring, execution, traceability, and reporting, and includes AI-enabled document generation, automated execution, instrument data capture, and built-in support for regulatory requirements (e.g., 21 CFR Part 11, Annex 11 and ALCOA+). Deployed as a cloud/SaaS solution and used for commissioning/qualification/validation (CQV), cleaning validation, continued process verification (CPV), CMC/QbD workflows, and tech transfers.
Industries
Nr. of Employees
large (251-1000)
ValGenesis
Patents
Residual limit determination for a cleaning agent corresponding to a validation of an equipment cleaning process
US-12366846-B2
View DetailsAutomated test case validation execution corresponding to a defined validation protocol
US-12332772-B1
View DetailsResidual limit determination for a cleaning agent corresponding to a validation of an equipment cleaning process
US-12174617-B1
View DetailsValidating and maintaining respective validation status of software applications and manufacturing systems and processes
US-9720687-B2
View Details
Residual limit determination for a cleaning agent corresponding to a validation of an equipment cleaning process
US-12366846-B2
View DetailsAutomated test case validation execution corresponding to a defined validation protocol
US-12332772-B1
View DetailsResidual limit determination for a cleaning agent corresponding to a validation of an equipment cleaning process
US-12174617-B1
View DetailsValidating and maintaining respective validation status of software applications and manufacturing systems and processes
US-9720687-B2
View DetailsProducts
Validation lifecycle management system (VLMS)
A cloud-based platform for paperless management of validation lifecycles including planning, authoring, execution, traceability, change management and reporting.
AI-enabled validation authoring and execution
AI-assisted document generation, decision-tree driven content, automated execution and real-time anomaly detection to accelerate validation workflows.
Process lifecycle tooling for QbD and CPV
Tools for Quality by Design, process risk scoring, multivariate analytics, SPC monitoring and automated CPV reporting to support process development through commercial verification.
ValGenesis Validation Lifecycle Suite (VLS)
Validation lifecycle management suite that integrates critical thinking tools, decision tree logic, and artificial intelligence to support computer software assurance (CSA) and computer system validation (CSV).
VAL The AI Validation Assistant
An AI agent designed to cut costs, speed validation, and reduce errors by automating document generation, gap assessments, execution, and anomaly detection.
ValGenesis Smart GxP
An AI-enabled digital validation platform that helps pharmaceutical leaders reduce audit prep time, cut validation cycles, and minimize observations.
Validation lifecycle management system (VLMS)
A cloud-based platform for paperless management of validation lifecycles including planning, authoring, execution, traceability, change management and reporting.
AI-enabled validation authoring and execution
AI-assisted document generation, decision-tree driven content, automated execution and real-time anomaly detection to accelerate validation workflows.
Process lifecycle tooling for QbD and CPV
Tools for Quality by Design, process risk scoring, multivariate analytics, SPC monitoring and automated CPV reporting to support process development through commercial verification.
ValGenesis Validation Lifecycle Suite (VLS)
Validation lifecycle management suite that integrates critical thinking tools, decision tree logic, and artificial intelligence to support computer software assurance (CSA) and computer system validation (CSV).
VAL The AI Validation Assistant
An AI agent designed to cut costs, speed validation, and reduce errors by automating document generation, gap assessments, execution, and anomaly detection.
ValGenesis Smart GxP
An AI-enabled digital validation platform that helps pharmaceutical leaders reduce audit prep time, cut validation cycles, and minimize observations.
Services
SaaS implementation, configuration, and deployment of an enterprise validation lifecycle management system for validation process digitization.
Application of PAT, MVDA, DoE and QRM to identify root causes, optimize controlled variables, scale-up processes and validate at commercial scale.
Training programs and partner resources to support digital validation adoption, organizational change and CSA readiness.
SaaS implementation, configuration, and deployment of an enterprise validation lifecycle management system for validation process digitization.
Application of PAT, MVDA, DoE and QRM to identify root causes, optimize controlled variables, scale-up processes and validate at commercial scale.
Training programs and partner resources to support digital validation adoption, organizational change and CSA readiness.
Expertise Areas
- Digital validation lifecycle management
- Commissioning, qualification and validation (CQV)
- Cleaning validation and MACO/ADE calculations
- Continued process verification (CPV) and process monitoring
Key Technologies
- AI-driven document generation
- Machine learning for anomaly detection
- Multivariate data analysis (MVDA)
- Statistical process control (SPC)
News & Updates
Customer and peer events focused on compliance-ready AI, digital validation and process lifecycle innovation; included demonstrations of cleaning validation tooling.
Press release announcing a partnership to accelerate adoption of digital validation solutions and combine technology with organizational change and CSA expertise.
Announcement of a senior marketing hire to lead global marketing strategy and go-to-market initiatives.
Press release describing selection of the validation lifecycle management system by a UK-based global CRO to digitize corporate validation and support CSV and CSA needs.
Press release describing a tier-1 nutraceutical manufacturer's deployment of a cloud-hosted validation lifecycle management system across multiple countries.
Recognition awarded to the company's paperless electronic validation management solution.
Customer and peer events focused on compliance-ready AI, digital validation and process lifecycle innovation; included demonstrations of cleaning validation tooling.
Press release announcing a partnership to accelerate adoption of digital validation solutions and combine technology with organizational change and CSA expertise.
Announcement of a senior marketing hire to lead global marketing strategy and go-to-market initiatives.
Press release describing selection of the validation lifecycle management system by a UK-based global CRO to digitize corporate validation and support CSV and CSA needs.
Press release describing a tier-1 nutraceutical manufacturer's deployment of a cloud-hosted validation lifecycle management system across multiple countries.
Recognition awarded to the company's paperless electronic validation management solution.