Thứ Năm, 23 tháng 6, 2022

GAMP RDI Good Practice Guide: Data Integrity by Design

 


Data Integrity by Design is the concept that data integrity must be incorporated from the initial planning of a business process through to the implementation, operation, and retirement of computerized systems supporting that business process. It promotes the application of critical thinking to identify how data flows through the business process and to proactively assess and mitigate risks across both the system and data lifecycles. It emphasizes data integrity as foundational to protecting patient safety and product quality.

GAMP Guide: Records & Data Integrity

 


The Guide is intended to be a complete and comprehensive single point of reference covering the requirements, expectations, and principles of pharmaceutical data integrity. Topics covered include regulatory focus areas, the data governance framework, the data life cycle, culture and human factors, and the application of Quality Risk Management (QRM) to data integrity. As such, it is of great interest to anyone with a responsibility for ensuring data integrity.

Phần mềm minitab 20 & 21


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