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.
Simplicity
-Facilitated and streamlined communication with your dedicated, single point of contact at SCIEX. -Integrated test and validation plans for a streamlined process. -Harmonized documentation in style, content and purpose.
Flexibility
-Customized validation documents to meet your laboratory's specific requirements. -Computer system testing tailored to your needs in terms of security settings, audit trails, user configuration, system configuration and more.
Cost control
-Achieve compliance at a fixed, predicted cost. -Save time and money with an exhaustive, streamlined compliance solution. -Minimize your instrument downtime by achieving compliance faster.
Speed
-Straight to the point. No need to create new validation tests and documents. -Save time and efforts by communicating with a single vendor for your complete system. -Get your system up and running in just a few days with SCIEX compliance expertise.
Peace of mind
-Proven record of over 10,000 qualifications and 1000 validations successfully delivered by SCIEX compliance experts. -Guarantee – Once SCIEX completes the compliance process, if auditors and any deficiency, SCIEX will address the issue, at no cost to you.
| Analytical instrument qualification |
|---|
| Includes non-method specific tests based upon accepted parameters such as: precision, detection linearity, accuracy and gradient operation. |
| MS IQ/OQ (mass spectrometer installation qualification / operational qualification*) |
| LC IQ/OQ (liquid chromatography installation qualification / operational qualification) |
| LC/MS PQ (LC/MS performance qualification – Some customers use this as a system suitability test (SST) |
*or re-qualification for systems in use
| Computerized systems validation |
|---|
| Includes system tests based upon regulatory requirements such as: security, user roles and privileges, audit Trail configuration, sample acquisition, data processing and analysis, network data management and reporting. |
| Software validation – V-model (Analyst, Analyst administrator console, SCIEX OS, MultiQuant software) |
| Software version upgrade (hotfix – Windows, Analyst, SCIEX OS software) |