Achieving compliance in a regulated analytical laboratory is a complex, time-consuming and costly journey that takes you away from the day-to-day operations of your lab. SCIEX offers compliance solutions that help ensure your lab produces quality data without delaying your projects. From start to finish, our team of compliance experts will guide you through the complete process.
Integrating instruments and information systems allows your lab to run more smoothly and efficiently. Your personnel will spend less time moving files and more time on their work.
Reduce your startup costs and decrease the time for returns on your technology investment. By improving laboratory efficiency and productivity, we can help lower your ongoing operating costs.
Get advice from experts on SCIEX instruments, software, and systems, who have in-depth knowledge of global regulatory compliance standards, including US FDA 21 CFR Part 11, GLP, and GMP guidelines.
We constantly update our knowledge of industry best practices and stay aware of changes in regulations.
SCIEX compliance products can provide customers with a complete system (LC, MS, software, LC-MS) solution that can minimize regulatory risk at a fixed predicable cost that reduces their need for inhouse expertise in the complicated world of regulatory compliance. Each product deliverable is completed using standard good document practices, is audit ready, helps removes the worry about regulatory compliance and incrementally increases the confidence a customer will have in their data quality.
Includes non-method specific tests based upon accepted parameters such as: precision, detection linearity, accuracy and gradient operation.
Products include qualification services for:
SCIEX provides software validation services that help ensure that your Analyst and SCIEX OS software are properly configured for data integrity and comply with FDA 21 CFR Part 11 regulations and similar global standards. Our validation services feature a complete GAMP-5, risk-based, V-model validation including validation plan, risk assessment, requirements specification, configuration specification, IQ, OQ, and PQ protocols, traceability matrix, Part 11 assessment, and validation summary report. Validation activities are performed by a highly trained and experienced validation specialist, resulting in highly compliant validation documentation, produced in a much shorter time.
The SCIEX team of compliance experts can help identify those areas of your lab operation that expose your organization to unnecessary regulatory risk. We can evaluate your SOPs, sample handling, validation activities, IT and data integrity systems, and more to ensure that you are ready for an upcoming audit. SCIEX will make specific suggestions, and can provide additional resources to update policies and procedures, streamline operations, and improve you lab’s resiliency and efficiency.
Integrating and optimizing the technology in your lab is ongoing. We can assist in maximizing automation to make your lab efficient and to mitigate risks of downtime and data loss.
Lean processing strategies to unlock productivity potential in your lab.
Support and training to help you optimize your applications, troubleshoot workflows, and get the most from your software.
We offer complete relocation solutions for your lab, so you have one less thing to worry about.