Simplify Validation.
Strengthen Quality.
Accelerate Compliance.
ValQMS empowers Life Sciences organizations with various tools which aid in validation, automation, and regulatory compliance.
GxP Validation & Project Management Application
Manage validation and compliance projects with Agile, Waterfall, and Hybrid methodologies
Smart Tools
Smart, compliant, and production-ready tools to enhance productivity and streamline validation processes.
Project Budget Calculator
Advanced, auditable project cost and effort estimator for pharma validation & qualification projects. Scenario, contingency, and export-ready.
Project Plan Creation Tool
Auto-generate project phases, tasks, Gantt (Excel), and RACI matrix for SAP, LIMS, UiPath, and more. Exports a ready-to-use Excel workbook.
Excel Comparison Tool
Advanced fuzzy matching with composite keys and colorized Excel exports. Perfect for validation evidence generation.
LIMS Master Data Tool
Automatic master data structuring with smart multi-line detection and intelligent field mapping for LIMS templates.
SOP Version Comparator
AI-powered side-by-side comparison with change detection, training impact analysis, and compliance reports.
User Access Matrix Builder
Visual RBAC matrix with AI-powered segregation of duties conflict detection and GxP audit reports.
Screenshot Evidence Converter
Batch annotate test screenshots with metadata, timestamps, and auto-generate PDF evidence appendices.
Advanced Risk Assessment Tool
GAMP 5 and ICH Q9 compliant risk scoring with automated validation strategy recommendations.
Quality Management System Applications
Interactive pharmaceutical QMS applications aligned with FDA 21 CFR Part 820, EU GMP, ICH Q10, and ISO 13485
Change Control
Manage change requests, impact assessments, and approvals with full audit trail
CAPA Management
Track corrective and preventive actions with root cause analysis and effectiveness monitoring
Risk Assessment
Conduct risk assessments with FMEA, HACCP, and ICH Q9 methodologies
Audit & Inspection
Manage internal and external audits, inspection readiness, and CAPA tracking
Training Management
Track employee training records, competencies, and certification requirements
Non-Conformance
Document and investigate non-conformances with root cause analysis and CAPA linkage
Defect Management
Track product defects, complaints, and quality issues with investigation workflows
Quality Management System Procedures
Complete pharmaceutical QMS procedures aligned with FDA 21 CFR Part 820, EU GMP, ICH Q10, and ISO 13485
ValQMS Academy
Purchase individual courses or subscribe for unlimited access to all training content
My Purchased Courses
Regulatory Resources
Stay compliant with latest guidelines and regulatory updates
Key Guidelines
Core frameworks for quality, validation, and data integrity
- FDA 21 CFR Part 11 - Electronic Records
- FDA 21 CFR Part 820 - Quality System Regulation
- EU GMP Guidelines - Annex 11
- ICH Q10 - Pharmaceutical Quality System
- ICH Q9 - Quality Risk Management
- ISO 13485 - Medical Devices QMS
- ISO 9001 - Quality Management Systems
- FDA Computer System Validation Guidance
- EMA Data Integrity Guidelines
- FDA Biologics Guidances
- 👥 RAPS - Regulatory Affairs Professionals Society
Regulatory Updates
Latest guidance, news, and agency publications
- FDA Guidance Documents
- EMA News & Events
- WHO Quality Assurance
- FDA Newsroom - Latest Updates
- FDA Guidance Documents
- EMA News & Events
- EMA Scientific Guidelines
- ICH News & Updates
- WHO News Room
- 🤝 PIC/S News & Updates
- FDA Drug Safety Communications
- FDA Medical Device Recalls
- EMA Pharmacovigilance Updates
- FDA Warning Letters
- FDA Compliance Actions
- EMA Regulatory Updates
- Health Canada Guidance
- MHRA News & Publications
- TGA (Australia) News
- PMDA (Japan) Updates
- CDSCO (India) - Central Drugs Standard Control
- NMPA (China) News
Regulatory Observations
Inspection guides, letters, and remediation insights
- FDA Inspection Guides
- FDA Establishment Inspection Reports (EIRs)
- FDA Warning Letters Database
- FDA Recent Warning Letters
- FDA Untitled Letters
- FDA Clinical Laboratory Improvement Amendments (CLIA)
- FDA Inspection Classifications Database
- EMA GMP Inspection Database
- EMA Non-Compliance Reports
- 🤝 PIC/S Inspection Reliance Database
- MHRA Inspection Reports
- Health Canada Inspection Reports
- TGA Compliance Actions
- WHO Inspection Reports
- 🧰 GMP Compliance - FDA Warning Letters Analysis
- FDA - Responding to Form 483
- 👥 RAPS - How to Respond to Warning Letters
- 🧰 GMP Compliance - Warning Letter Response Guide
- 🧪 ISPE - Inspection Readiness & Response
- 🧪 PDA - Inspection & Remediation Resources
- 🦅 FDA CGMP Change Control Findings
- 🧰 GMP Compliance - Change Control Violations
- 🗞️ Pharma Tech - Change Control Inspection Findings
- 🗞️ In-Pharma - Change Control Deficiencies
Why ValQMS?
Built by validation experts for validation experts
⚡ All-in-One QMS Platform
Change control, CAPA, deviations, training, risk management, and audit tools - all integrated in one platform
🔒 End-to-End Validation
Complete project and validation lifecycle management from GxP assessment to go-live with GAMP 5 compliance
☁️ Zero Installation
Zero installation required. Access anywhere, anytime. Your validation data is secure and backed up automatically
🎯 Automated Workflows
Smart GxP assessment, automatic version tracking, and risk-based validation. Reduce manual effort by 70%
🛡️ Regulatory Compliant
Built-in compliance with FDA, EU GMP Annex 11, and GAMP 5 guidelines with complete audit trails
👥 Team Collaboration
Cloud-based platform enabling real-time collaboration across validation, QA, and IT teams. Track progress, assign tasks, and manage deliverables seamlessly.
📊 Real-Time Analytics
Live dashboards and reports. Monitor project status, resource allocation, and validation metrics in real-time
🚀 Inspection-Ready
Complete audit trails, traceability matrix, and instant reporting. Be audit-ready at all times