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The Quality System Manual was written by the FDA to assist manufacturers with compliance activities. The Manual covers requirements of the QSR that manufacturers must consider when they design medical devices, or when they manufacture, contract manufacture, remanufacture, process, repack, or relabel finished medical devices intended to be commercially distributed. The Manual contains articles that explain the Agency’s various GMP requirements such as design controls, process validation, calibration, device master records, component control, etc., along with related topics such as labeling. It contains examples of forms, procedures, decals, and more. Al Weisenborn’s QSR-GMP Help links the Quality System Manual directly to 21 CFR Part 820, placing the Manual’s guidance in the direct context of the QSR. Accessible from the main menu or from within the QSR Application, the Quality Systems Manual is fully indexed and keyword-searchable. Al Weisenborn’s QSR-GMP Help allows you to navigate quickly and clearly through this essential Guidance. The full Table of Contents is linked to corresponding sections of the document. The guidance is fully indexed and keyword-searchable. The guidance may be accessed from the QSR Application or directly from the Main Menu.
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