Validation & Qualification

(URS, PQ, PPQ & CCV)

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Service Details

Technical Standards

Validation & Qualification

Full lifecycle support – from URS to PQ, including Process Validation.

Confirming that your facilities, utilities, and equipment consistently deliver products meeting defined quality requirements. UDQS develops fully compliant validation protocols aligned with WHO, EU GMP, PIC/S, and national regulatory expectations.

URS & Design

  • User Requirement Specifications
  • Process equipment & production lines
  • QC lab instruments & systems
  • Design Qualification (DQ) reviews

Utility Qualification

  • PW / RO / EDI water systems
  • Clean steam & compressed air
  • HVAC & Environmental controls
  • Calibration & loop verification

Equipment IQ / OQ

  • Installation verification (IQ)
  • Utility connection checks
  • Functional testing (OQ)
  • Alarm & control system verification

Performance (PQ)

  • Trial runs under routine conditions
  • Consistency & reproducibility checks
  • Performance Qualification reports
  • Worst-case scenario testing

Computerized Systems

  • Computer System Validation (CSV)
  • GAMP 5 based risk assessments
  • 21 CFR Part 11 compliance
  • Software & Data Integrity audits

Specialized Services

  • Cleaning Validation protocols
  • Analytical method validation
  • FAT / SAT technical support
  • Validation Master Plans (VMPs)

Advanced Process Validation

UDQS supports the modern three-stage approach to Process Validation in line with WHO, EMA, FDA, and ICH Q8–Q10 guidelines. We ensure your processes are scientifically understood and controlled.

  • Process Performance Qualification (PPQ) batches
  • Continued Process Verification (CPV) plans
  • Statistical sampling & acceptance criteria

Quality tested service delivery for complex manufacturing.

Let’s Build Your Path to Regulatory Excellence.

Delivering Global Standards Across Africa

With deep roots in the region, UDQS provides technical intellect tailored to the African regulatory landscape. We transform manufacturing facilities into world-class, export-ready assets.

Audit-Proven Methodologies
Risk-Based Technical Delivery
On-Site Operational Support
Localized Regulatory Intelligence

Our consultants bridge the gap between rigorous international requirements and local operating conditions, ensuring your path to compliance is both sustainable and scientifically sound.

Compliance Frameworks
WHO TRS EU GMP PIC/S ISO 9001 ISO/IEC 17025 ICH Q8–Q12 ISO 14644 ALCOA+ GAMP 5

Ready to Elevate Your Quality Standards?

Our technical experts are standing by to help you navigate the complexities of facility readiness, laboratory qualification, and regulatory submission.