Overview
The benefits of integrated compliance services for your mass spectrometry lab
Productivity
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.
Value
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.
Experience
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.
Best practices
We constantly update our knowledge of industry best practices and stay aware of changes in regulations.
Lab compliance consultancy portfolio
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.
Instrument qualification (IQ/OQ/PQ)
Includes non-method specific tests based upon accepted parameters such as: precision, detection linearity, accuracy and gradient operation.
Products include qualification services for:
- Mass spectrometer installation qualification / operational qualification (MS IQ/OQ)
- Liquid chromatography installation qualification / operational qualification (LC IQ/OQ)
- LC-MS performance qualification (LC-MS PQ)–some customers use this as a system suitability test (SST)
Product features:
- Comprehensive report with clear performance vs acceptance criteria that is audit ready
- Training certificate of qualified FSE that performs the qualification
- Traceability of standards used
- Certification of all measurement tools used during qualification
Software validation
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.
Audit preparation
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 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 your lab’s resiliency and efficiency.
Our areas of expertise
Software and IT services
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. We specialize in the migration form Analyst to SCIEX OS software ensuring a seamless transition to the latest and most powerful software for your system.
Lab optimization
Let our team of experts audit and assess your laboratory workflows and process strategies to unlock productivity potential in your lab. This optimization service will improve efficiencies of your labs which could help contribute to your operation's bottom line.
Consulting and customized lab training
Lab staff turnover sometimes puts your workflow in a knowledge deficit. Support and training packages are available to improve onboarding and upskilling to drive productivity and system efficiencies. Training will enable consistency of your workflows, and system maintenance along with increased staff confidence and proficiency in operating your systems.
Lab relocation services
Sometimes, you must move your systems from one room to another, or to another building, state or country. Regardless of your need, offers a relocation service that protects your system throughout its journey and reinstallation.