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Lab compliance services

Lab compliance services

SCIEX is the right partner to choose for a compliant mass spectrometry lab.

Overview

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.

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.

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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 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.