Audit-Ready Validation with Structured Documentation

In regulated industries, validation is not optional—it is the foundation of compliance and operational trust. VISIOTT TPS supports customers with a structured validation approach for track & trace and packaging environments, including Computer System Validation (CSV) activities and Factory Acceptance Testing (FAT), along with the technical documentation required for internal quality teams and external audits. This validation support is specifically focused on Track & Trace systems and their related serialization and packaging environments.

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Our Validation Scope

We deliver a risk-based validation framework designed to maintain validated state continuity while supporting operational flexibility from factory testing to final qualification.

Risk-Based Assessment

Identification of critical system components and impact classification aligned with GMP principles.

  • Impact evaluation
  • Critical control points
  • Validation scope definition

IQ / OQ / PQ Execution

Structured execution of validation protocols under controlled documentation standards.

  • Installation Qualification
  • Operational Qualification
  • Performance Qualification

Traceability & Documentation

Complete traceability from requirements to executed test evidence.

  • Traceability Matrix
  • Deviation handling
  • Final approval records

Compliance Alignment

Our validation methodology aligns with internationally recognized standards and industry expectations to ensure inspection readiness and documentation clarity.

  • GMP-oriented documentation practices
  • GAMP5-based validation philosophy
  • Change control & revalidation support
  • Audit preparation assistance

Designed for Audit Confidence

Our documentation packages are structured for internal QA review and external inspections, ensuring transparency, traceability, and clarity during audits.

Validation Lifecycle

A structured and controlled lifecycle approach ensures validation is not a one-time activity but a sustained compliance strategy.

1. Scope Definition

Risk and requirement mapping

2. Protocol Development

Controlled documentation drafting

3. IQ / OQ / PQ

Installation and operational testing

4. Reporting & Handover

Evidence package & approval

Validation Requests via Email

Please submit your validation and compliance requests via email. Your request will be logged and assigned to the appropriate specialist.

support@visiott.com