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ValiFlow — Pharma Validation Software That Passes Every Audit
ValiFlow automates your full validation process — from writing protocols to final reports — with built-in 21 CFR Part 11 compliance and electronic signatures. Used by pharma manufacturers, API companies, and biotech firms in India and globally.
ValiFlow Core
Validation Lifecycle Management
Manage your full validation process in one platform — from user requirements through IQ/OQ/PQ, deviations, CAPA, and final reports. Everything is tracked and audit-ready.
- ✓URS to PQ protocol templates
- ✓Risk-based validation
- ✓Deviation and CAPA tracking
- ✓Electronic signatures
- ✓VMP generation
- ✓Role-based access control
ValiFlow CSV Manager
Computer System Validation Automation
Stop using spreadsheets for CSV. Keep full traceability from user requirements to validation closure with automatic RTM, protocol versioning, and system integrations.
- ✓Automatic traceability matrix
- ✓Protocol version control
- ✓Vendor audit docs
- ✓LIMS/QMS/ERP integration
- ✓Electronic document management
- ✓Post go-live support
ValiFlow CSA Module
Computer Software Assurance
Move from old CSV to FDA's new CSA approach. Use risk-based workflows and reduce paperwork while staying fully compliant with FDA's 2022 CSA guidance.
- ✓CSA risk categories
- ✓Intended use documents
- ✓Critical thinking templates
- ✓Agile-friendly workflows
- ✓FDA 2022 CSA guidance
- ✓Automated compliance records
ValiFlow Cleaning Validation
Automated MACO and Cleaning Validation
Automate cleaning validation from start to finish. The built-in MACO calculator, worst-case selection, and sampling protocols save 400–500 hours of spreadsheet work per study.
- ✓Automatic MACO/ADE/PDE calculation
- ✓Worst-case product selection
- ✓Swab and rinse protocols
- ✓Cleaning Validation Master Plan
- ✓EU Annex 15 and FDA 21 CFR compliant
- ✓One-click audit-ready report
What Our Validation Team Delivers
We handle all stages of process validation for pharma manufacturing.
Regulatory Frameworks We Support
Every service and software module is designed to meet these global pharma regulations.
Make Your Next FDA Inspection Your Easiest One
Book a 30-minute ValiFlow demo and see how pharma teams cut validation time by 60% while keeping full audit trail coverage.