Thermo Fisher Scientific Publishes New White Paper on Achieving Regulatory Compliance
Molecular Spectroscopy
Thermo Fisher Scientific Inc., the world leader in serving science, has published a new white paper to demonstrate the value of employing a full-system approach to achieving compliance for Thermo Scientific molecular spectroscopy systems. Titled “Choosing the Right Instrument Vendor for Complete, Cost-Effective Compliance”, the white paper provides an in-depth discussion of the cost considerations, opportunities and risks associated with selecting an appropriate vendor based on their compliance capabilities. This all-inclusive document addresses compliance issues in manufacturing settings where external regulation or self-regulation is important, including pharmaceutical, consumer products, food and beverage, and many other industries. It is available here, free of charge.
The 19-page white paper provides a thorough understanding of compliance basics to help laboratory managers, chief scientists and regulatory specialists determine the real value of an instrument vendor’s compliance capabilities and better evaluate their spectroscopy systems. Additionally, it details available processes for instrument validation, qualification and verification while also mapping out these processes in highly regulated (cGMP, FDA), moderately regulated (GLP, ISO) and self-regulated (Six Sigma) manufacturing environments.
Traditionally, full system validation covering the spectrometer, software, accessories and standard operating procedures is a particularly time consuming and expensive procedure. Thermo Fisher Scientific enables its molecular spectroscopy customers to overcome these challenges by offering a comprehensive suite of compliance products and services that reduce the overall cost, complexity and risk of implementing a compliance program for a new spectrometer. The company provides all the necessary tools to complete the qualification and validation process quickly and acquire documented evidence that the instruments will produce accurate results. Thermo Scientific molecular spectroscopy systems can be configured to fully comply with the FDA 21 CFR Part 11 regulations for closed systems using a common administration tool that allows managing user and instrument compliance policies from a single point of control.
Thermo Scientific is part of Thermo Fisher Scientific, the world leader in serving science.
