Good documentation practices

What is meant by breaching in data integrity ?

Data breach, in the context of data integrity, refers to when there is an unauthorized access to data that could pose risks to data integrity, either by theft of data that could manifest in data loss or unappropiate use of data; or by data alteration or falsification.

Data breach can occur for all types of data, not only electronic records, but also manually recorded data, in the form of records, logbooks, etc.

There must be systems in place to control and ensure data integrity, and to be able to verify if there has been a data breach that could impact data integrity. this is done, by manual procedures, restricted access rooms, copmuter system credentials, auditrail, antivirus, firewall, etc.

You can look for guidelines for Data Integrity in:
FDA - Data Integrity and Compliance With CGMP Guidance for Industry
ISPE - GAMP Guide: Records & Data Integrity
WHO - Guidance on good data and record management practices

I hope this is useful.

A data breach is **an incident where information is stolen or taken from a system without the knowledge or authorization of the system’s owner . A small company or large organization may suffer a data breach.

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