Pharmacy Courses

Data Integrity by Design | GxP Compliance

For pharmaceutical organisations, both data integrity and data quality are required. However, the two concepts are not the same. 

While data integrity focuses on providing a value that can be trusted by users, data quality focuses on providing attributes around data values to enable people to efficiently sort, search and filter values, according to the International Society for Pharmaceutical Engineering (ISPE). 

Data integrity is a very broad concept – varying from the traceability of source data to its security.

On the other hand, data quality is the extent to which data is suitable and valid as an information source for operational or strategical decision processes.

Thorough data integrity contributes to improved data quality, but data quality doesn’t automatically mean that your organisation is assured of good data integrity.

Data Integrityby 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.

The ISPE GAMP® RDI Good Practice Guide: Data Integrity by Design, supports organizations as they embrace and implement a holistic approach by leveraging data governance and knowledge management activities to drive continual improvement in data integrity. The Guide promotes a patient-centric mindset, focusing resources and management attention on quality best practices that inherently facilitate meeting regulatory compliance requirements.

Several new areas are covered in this Guide. One such topic is Knowledge Management (KM), which can be considered the link between data governance and quality risk management. KM enables organizations to make decisions more efficiently and encourages an organizational culture of learning.

The ISPE GAMP® RDI Good Practice Guide: Data Integrity by Design offers a pragmatic, practical approach to the identification and remediation of the risks, and endorses the adoption of working practices to protect and review the electronic records.

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