Data Integrity is defined as, “the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be Attributable, Legible, and contemporaneously recorded, Original or a true copy, and Accurate.”
This is also known as the ALCOA principle guiding Data Integrity. The CCEA concept was added by European agencies.
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ALCOA – How to achieve?
Automation Architecture for Data Integrity Assurance
This is the core architecture of a data integrity assurance system. Any application system can generate data based on metadata (e.g. Method). Data can be re-processed by varying the metadata.
A system that can provide controlled access to the “Application Data System” and at the same time keep track of changes to the data and metadata will assure the integrity of data generated.
The validation of such information has to be done by the automation system. The central storage becomes the single source of “Truth”. Data can be easily verified for its accuracy by human & electronically signed.
This is the concept followed by our solutions LogiLAB SDMS, LogiLAB ELN and CFR Gateway modules.