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Lab Equipment

Stem Cell Total Solution Provider N-BIOTEK

Validation

To maintain the best performance of the equipment, N-BIOTEK provide Validation Service by professional quality manager

Validation Inquiry
Verification correlation DQDesignReview PQ OQ IQ DesignSpecification FunctionSpecification InstallationSystem Build URS

URSUser Requirement Specification

DQDesign Qualification

FSFunctional Specification

DSDesign Specification

IQInstallation Qualification

OQOperational Qualification

PQPerformance Qualification

N-BIOTEK provide reports of IQ, OQ, PQ using professional inspection equipment to check suitability of Safety Standards for GMP Facilities.

MAIN VALIDATION EQUIPMENT
  • VAISALA MI70
  • GRAPHTEC GL840
  • YOKOGAWA DX2030
  • MADGETECH PRTemp140
WHY N-BIOTEK?
01

Review User Requirements Specification (URS) and Manual to provide professional validation services based on GMP requirements.

02

Various precision measuring instruments in possession. * Measuring section: Temperature, CO2, Humidity, Pressure, RPM etc.

03

Fast and trustworthy service through N-BIOTEK’s validation specialist.* Validation service available for other brand’s equipment.

04

Provide “One-line service” for quality assurance and customer friendly management. * Equipment + Validation + After-sales service

SERVICE CONTENTS
Installation
Qualification (IQ)

On-site verification and documentation for proper standardized installation of equipment, facility, or system.

Operational
Qualification (OQ)

Verification and documentation for proper equipment, facility, or system’s operation intended within predicted range.

Performance
Qualification (PQ)

Verification and documentation for manufacture according to the set quality standards.

Others

Deviation analysis/report Operation/Maintenance manual Certificates of calibration for inspection equipment Certificates of calibration for equipment

01

Determination of qualification assessment targets and request validation

02

Determination of qualification assessment targets and request validation

03

Start qualification assessment
IQ · OQ : Avg. 2~3 days
IQ · OQ · PQ : Avg. 4~5 days

04

Approve validation report