Validfor

Validfor is an AI-native digital validation platform built for life sciences and regulated industries, including pharmaceutical, biotechnology, and medical device sectors. It replaces static, document-centric validation lifecycle management (VLM) tools with an intelligent, continuously compliant infrastructure that manages the full validation lifecycle from a single secure platform using a modular approach.

The platform addresses core problems in traditional validation: teams spending months producing documentation that becomes obsolete when systems change, compliance activities that are reactive rather than continuous, and legacy tools that cannot keep pace with dynamic AI-driven systems. Validfor positions itself as a new category of validation infrastructure — one focused on continuously understanding, validating, and adapting systems in real time rather than managing static documents.

Core Platform Capabilities

• Paperless validation workflows with electronic signatures and electronic records
• Data integrity maintained through interconnected records and real-time monitoring
• Modernised audit trails and data security controls with role-based access
• Tailored validation rules with real-time, dynamic traceability and intelligent linking
• Eco-friendly validation through digital-first processes, replacing paper-based workflows (GreenShift and DigiFlow features)
• Comprehensive validation lifecycle management covering implementation through system retirement

Agentic AI Features

• System Understanding: AI agents analyse system requirements and automatically detect changes to keep validation aligned with evolving systems
• Automated Validation Artifacts: Generates validation protocols, reports, and required documentation without manual effort
• Continuous Compliance Monitoring: Maintains traceability and detects compliance gaps before they become audit risks
• Agent-driven workflows replace manual processes, shifting from reactive to continuous compliance
• Dynamic traceability replaces static traceability found in legacy VLM tools

Supported Validation Use Cases

• Computer System Validation (CSV) and Computer Software Assurance (CSA)
• AI/ML system validation for machine learning and AI systems
• GxP compliance workflows with full traceability and audit readiness
• Digital transformation programmes with structured validation and compliance frameworks
• Systems including ERP (SAP, Oracle), MES (PAS-X, POMSNet), LIMS (LabWare, LabVantage), QMS (TrackWise, MasterControl), DMS (MasterControl, Veeva Vault), BMS (Honeywell, Schneider), production equipment, laboratory equipment, and cleaning validation

Regulatory Standards and Compliance Frameworks

• Supports GAMP 5, 21 CFR Part 11, and Annex 11
• ISO 27001 (information security management)
• ISO 27701 (privacy information management)
• ISO 27017 (cloud services information security)
• ISO 27018 (personal data protection in the cloud)
• ISO 27005 (information security risk management)
• ISO 22301 (business continuity management)
• GDPR and HIPAA compliance

Data Security Measures

• Data encryption in transit and at rest
• Role-based access controls limiting access to authorised personnel
• Comprehensive audit trails tracking all user activities and data modifications
• Regular data backups to prevent data loss
• Secure, industry-standard hosting infrastructure

Target Users

• Heads of QA and Validation — reducing validation timelines from months to days while maintaining audit readiness
• Pharma enterprises — scaling validation across complex, AI-driven systems without increasing operational burden
• Digital transformation teams — removing validation bottlenecks that block innovation
• Validation professionals, quality assurance teams, IT departments, system owners, and project managers

Implementation and Support

• Cloud-based deployment with configuration, data migration, and user training provided
• Tools for tracking timelines, resources, and costs associated with validation activities
• Alerts and notifications to support on-schedule, within-budget delivery
• Onboarding and training, technical support, documentation and resources, and ongoing platform improvement based on customer feedback

Validfor is available globally, with services provided across more than 25 countries including the United States, Germany, the United Kingdom, France, Japan, Canada, and others. The platform is backed by global venture capital investors and is designed for enterprise-scale deployment in regulated environments.