Precision Compliance for Analytical Equipment

From HPLCs to titrators to stability chambers, laboratory computerized systems require rigorous validation to produce inspection-ready documentation. Our team have optimized over 2000 analytical instruments, including:

– Chromatography Systems

• HPLC
• Gas Chromatographs
• Ion Chromatographs
• Mass Spectrometers

– Dissolution Testing Apparatus 

– FTIR Systems

– TOC Analyzers  

– pH Meters

– Spectrophotometers

– Bioreactor Controls

– Stability Chambers

– LIMS Configurations

By establishing test cases that confirm precision installation, operational reliability, and performance robustness, our protocols verify: 

• Data integrity protections work 
• Configurations match methods  
• Calculations are accurate
• Recovery procedures function
• Audit trails capture modifications
• Change controls prevent unauthorized changes
• Calibrations stay in tolerance

“The documentation Valitech produced enabled our lab equipment qualification process to proceed 3x faster through GMP inspections.”  

VP Quality, Aurora Laboratories

Our project deliverables include: 

• User Requirements 
• Functional & Design Specs
• Risk Analysis
• Traceability Matrices
• IQ, OQ, PQ
• Validation Summary Report

With turnkey validation packages ready for client signature, have absolute confidence in the compliance and capabilities of your quantitative business backbone.