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Help save time and simplify compliance with our support
Partnering with Thermo Fisher Scientific for genetic analysis provides you with unparalleled support through superior services, remote tools, training, and technical expertise. Help streamline development and simplify compliance with service and support solutions that enable you to maintain your focus and your timelines.
cGMP (current Good Manufacturing Practice) refers to the set of regulations enforced by U.S. FDA (Food and Drug Administration), and it includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. Our cGMP product offering includes instrument qualification services and a computer system validation consulting service to help address the FDA’s Code of Federal Regulations (CFR) by demonstrating manufacturing compliance. We also offer robust instrument hardware service plans that can help ensure reliability and consistency in your work by providing fast issue resolution.
Instrument hardware qualification
With our instrument qualification services, you can be confident that your instruments are installed, operating, and performing according to manufacturer’s specifications. Our manufacturer-trained and -certified field service engineers (FSEs) conduct comprehensive testing of your instruments using verified tests, certified tools, and developed standards to verify instrument performance. Reliable, audit-style documentation is provided to help you meet regulatory requirements and industry standards.
Installation qualification, operational qualification, and instrument performance verification
The purpose of a qualification is to generate documented evidence that an instrument in a workflow is performing within the manufacturer’s design specifications. Qualification services (installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and instrument performance verification (IPV)) address the following:
- 21 CFR Part 58—Good laboratory practice (GLP) for nonclinical labs
- 21 CFR Part 210 and 211—Good manufacturing practice (GMP) for human drugs
- 21 CFR Part 312—Good clinical practice for investigational new drug application
- 21 CFR Part 820—Quality system requirements (medical devices)
- 21 CFR Part 11—Electronic records and signatures
Qualification services are also applicable to International Organization for Standardization (ISO) standards, including: ISO 9001, 13485, 14971, 17025, and 15189.
Computer system validation (CSV)
Validation of computer systems supports data accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records as a critical requirement of electronic record compliance described in the FDA 21 CFR 11.10(a) and EU Annex 11. Our CSV consulting service provides comprehensive validation consulting, testing, and documentation that helps ensure that computer data security, auditing, and e-signature software features are in compliance with industry standards and regulatory guidance.
Instrument service plans
There’s no time for downtime in your lab. Built on 40 years of service expertise, our superior service solutions for Applied Biosystems instruments and applications help keep your lab up and running. More than 2,000 trained professionals make up the industry’s largest network, ready to assist you when you need it. And smart features such as remote instrument services help keep you productive and focused on making the next discovery. Customers worldwide count on us to deliver industry-leading service and support featuring faster response time, cost savings, proactive instrument care, and easier instrument qualifications.
For Research Use Only. Not for use in diagnostic procedures.