The FL 8500 Fluorescence Spectrophotometer with Spectrum FL 21 CFR Software has superior accuracy for right first time results even on diluted or small sample amounts. Rapid scanning increases sample throughput and maximizes your productivity. Types of analysis include material characterization; industrial tracing and manufacturing R&D; agricultural and environmental analysis; and analysis of LEDs, solar cells, and organic electroluminescent materials. View the interactive online brochure to see how the FL 8500 can support your needs.
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The FL 8500 Fluorescence Spectrophotometer with Spectrum FL 21 CFR Software uses a continuous wave excitation source for high sensitivity measurements at scan speeds up to 60,000 nm/min.
Features and Benefits include:
The US Pharmacopoeia method USP<853> (which is part of USP 40) gives some guidelines for measuring performance of fluorescence spectrometers. The Spectrum FL softwareused for the FL6500 and FL8500 has a validation module which can be used to test key...
The FL 6500 and FL 8500 use interchangeable, plug-and-play accessories, intuitive software that mirrors your laboratory workflow, and support and services that validate your equipment and ensure standard compliance regulations are met.
EXELEAD, a biopharmaceutical CMO, knew Data Integrity was an area of vital interest to the FDA during a recent on-site visit and wanted to make sure there were no shortcomings on their end as a part of an ongoing commitment to quality processes.
The FDA defines data integrity as “completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA)”. ALCOA itself has evolved to ALCOA Plus, which incorporates two of the fundamental definition terms as stated by the FDA; complete, consistent, enduring and available. Compliance with 21 CFR Part 11 is mandatory for pharmaceutical companies and their suppliers to sell products into the United States, and also applies to other related industries.
PerkinElmer’s Spectrum™ FL Enhanced Security (ES) software platform for fluorescence spectroscopy provides structural requirements and features to match the specific needs for ensuring data integrity. It affords the system owner the ability to comply with regulations and incorporate features into the validation plan to exhibit compliance. The purpose of this document is to demonstrate how Spectrum FL ES meets the technical requirements for 21 CFR Part 11.
