GLOBAL N-BIOTEK

Products

Validation

GLOBAL N-BIOTEK provides the Best Validation Service, fully compliant with GMP standards, through its team of specialized technical experts for laboratory equipment, facilities, and systems.

Main Validation Equipment

GLOBAL N-BIOTEK conducts detailed qualification

assessments of IQ, OQ, and PQ using specialized inspection equipment

and technical experts to determine compliance with GMP facility,

laboratory equipment performance, and quality standards.

VAISALA

MI70

GRAPHTEC

GL840

YOKOGAWA

DX2030

MADGETECH

PRTemp140

Why

Global N-biotek

Reviewing User Requirement Specifications (URS) and manuals to
provide professional validation services in accordance with GMP requirements

Possession of numerous precision measuring
instruments recognized worldwide

* Measurement range: temperature, CO₂, humidity, pressure, RPM, etc.

Fast and highly reliable services provided
by GLOBAL N-BIOTEK’s professional validation experts

* Capable of delivering validation services for laboratory equipment,
facilities, and systems across the industry

An integrated ‘One-Line Service’ management system that
combines quality assurance with customer-tailored services

* Laboratory Equipment and Facility Manufacturing · Validation · After-Sales Service

Validation

GLOBAL N-BIOTEK Inc.

IQ Installation Qualification

Verifying and documenting that machines, equipment, or systems have been installed according to the established standards
Calibration requirements, verification tests of components, etc

OQ Operational Qualification

Verifying and documenting that machines, equipment, or systems operate as intended within the anticipated operating range
Testing under conditions that encompass the upper and lower operating limits, referred to as the 'worst-case conditions

PQ Performance Qualification

Verifying and documenting that machines, equipment, or systems are capable of manufacturing products in accordance with the established quality standards
Testing with manufacturing materials, suitable substitutes, or simulated products under conditions that encompass the upper and lower operating limits

Others
Others

Deviation analysis/Report
Nonconformity Analysis/Report
Operation/Maintenance manual
Certificates of calibration for inspection equipment
Certificates of calibration for equipment

Working

Process