To maintain the best performance of the equipment, N-BIOTEK provide Validation Service by professional quality manager
Validation InquiryValidation
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
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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
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Installation
Qualification (IQ) -
On-site verification and documentation for proper standardized installation of equipment, facility, or system.
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Operational
Qualification (OQ) -
Verification and documentation for proper equipment, facility, or system’s operation intended within predicted range.
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Performance
Qualification (PQ) -
Verification and documentation for manufacture according to the set quality standards.
- Others
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Deviation analysis/report Operation/Maintenance manual Certificates of calibration for inspection equipment Certificates of calibration for equipment
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01
Determination of qualification assessment targets and request validation
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02
Determination of qualification assessment targets and request validation
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03
Start qualification assessment
IQ · OQ : Avg. 2~3 days
IQ · OQ · PQ : Avg. 4~5 days
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04
Approve validation report
