The term Data Integrity refers to the accuracy, completeness and consistency of data in its lifecycle and is critical to the design, implementation and use of any computer system in the GxP environment.
On the strength of a wealth of experience gained from working in various corporate contexts, QStep, thanks to a team with interdisciplinary skills, has developed a method that, starting from an analysis of processes and systems, enables the identification of data integrity risks and the implementation of the control measures necessary to mitigate and manage them, assisting the company in the correct interpretation and application of international regulations and guidelines, such as 21 CFR part11, EU Annex 11, GAMP, GDPR, CISM, ISO 27001.
Our services on Data Integrity:
- Data Integrity Awareness e Training
- Data Integrity Policy & SOPs
- Data Integrity Assessment
- Data Integrity Remediation Plans
- Business Process Mapping & Data Flow Diagram
- Risk Based Audit Trail Review