The OneSource® UOQ program provides an instrumentation qualification program for maximum productivity and ongoing regulatory compliance capability. The program encompasses, where applicable, pharmacopeial (USP, EP and JP) compliance with a design and approach that streamlines documentation across all major models of laboratory instruments, regardless of manufacturer. OneSource Compliance Services is ensuring the highest levels of compliance with international regulations and guidelines. UOQ enables a seamless, cross-platform approach to a contemporaneous and automated documentation process, letting you gain immediate access to raw data from computer or database, for increased scientific productivity.
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UOQ was developed to heighten compliance to OQ technology by using smart PDFs that comply with 21CFR Part 11. The UOQ is a configurable protocol adhering to ALCOA and increases security and streamlines the qualification process across multiple vendors.
With our UOQ service, you can boost scientific productivity, increase instrument availability, reduce overall costs due to instrument downtime, and maximize overall organizational efficiency. That’s because UOQ services streamline the qualification process for all lab instrumentation, allowing you to consolidate onto a single integrated solution. And for ease of documentation tracking, it enables you to harmonize documents across all models of lab instruments, regardless of manufacturer. The service:
Revision to General Chapter USP 857, which emphasized on performance specifications for UV-Vis Spectrometers (e.g. Lambda 365), on December 1st 2019 USP officially announced the amended chapter with new regulations on testing parameters. There are some major modifications made related to calibration parameters which will supersede the earlier method protocols that were practiced in the regulated environment of QA/QC lab. This PerkinElmer note gives a quick look at the parameter changes and additions to the test limits and wavelengths to be tested.