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.