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Preparation for QSR Review Working Agreement PCI LEADS: QA Lead(s) REGION: DATES OF REVIEW: Deadline TASK Responsible Party (14 16 Weeks) Identify RM & QA Lead for the region PCI (14 16 Weeks) Send
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QSR 16 week preparation refers to the process of preparing a Quality System Report for a 16-week period.
All regulated companies in certain industries are required to file QSR 16 week preparation.
QSR 16 week preparation can be filled out by compiling data on quality system activities over a 16-week period and submitting the report to the appropriate regulatory authorities.
The purpose of QSR 16 week preparation is to ensure that regulated companies are maintaining compliance with quality system regulations over a specified period of time.
Information that must be reported on QSR 16 week preparation includes details on quality system activities, any incidents or deviations, corrective actions taken, and any changes made to the quality system.
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