Instrument Qualification and Software Validation
Regulatory compliance and software validation can be complex, time-consuming, and costly. Having experienced support at your side provides an added peace of mind. SCIEX offers trained, certified engineers to guide you through Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Re-Qualification processes as part of your overall system validation.
If your laboratory operates in a regulated environment, you may be required to validate your software. Global standards (e.g., GLP, GCP, GMP) and country-specific regulations (e.g., US FDA 21 CFR Part 11, Annex 11) require validation of electronic, record-keeping systems to ensure their accuracy, reliability, and consistent performance, as well as to ensure each system's ability to identify altered or invalid records. Our on-site validation services can help you meet these requirements and reduce your compliance risk.