Validation Services

Home / Services / Validation Services

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.

21 CFR Part 11 Ready

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.

60% Faster Protocol Approval
100% Audit Trail Coverage
  • URS to PQ protocol templates
  • Risk-based validation
  • Deviation and CAPA tracking
  • Electronic signatures
  • VMP generation
  • Role-based access control
GAMP 5 Aligned

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.

80% Less Documentation Work
50% Faster CAPA Closure
  • Automatic traceability matrix
  • Protocol version control
  • Vendor audit docs
  • LIMS/QMS/ERP integration
  • Electronic document management
  • Post go-live support
FDA CSA 2022

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.

40% Less Documentation
FDA CSA 2022 Aligned
  • CSA risk categories
  • Intended use documents
  • Critical thinking templates
  • Agile-friendly workflows
  • FDA 2022 CSA guidance
  • Automated compliance records
EU Annex 15 Ready

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.

98% Less MACO Calculation Work
70% Faster Cycle Time
  • 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.

FDA 21 CFR Part 11EU Annex 11GAMP 5EU GMP Annex 15ICH Q10WHO-GMPISO 13485FDA CSA 2022ALCOA+CDSCO IndiaSchedule MICH Q2(R1)FDA 21 CFR Part 11EU Annex 11GAMP 5EU GMP Annex 15ICH Q10WHO-GMPISO 13485FDA CSA 2022ALCOA+CDSCO IndiaSchedule MICH Q2(R1)

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.