Data Integrity, Privacy and Information Security

Within a regulated environment data compliance with ALCOA+ is  indispensable. Within our Data Integrity Assessment Service we evaluate to which degree your data and data governance process complies with the ALCOA+ principle. We support you with implementing effective strategies to manage data integrity risks and stay compliant with the industry standards for data integrity.

Solution

• Define Data Integrity / Data Governance Strategy according to FDA CFR Part 11 and all relevant guidelines (WHO, MHRA, PIC/S)  

• Develop Data Integrity Implementation Plan and all relevant SOPs and templates

• Conduct Data Integrity Gap and Risk Assessments  

• Develop Data Integrity Risk Catalogue

• Data Integrity Audit Preparation and Execution  

Benefits

Data is the new gold! To protect your most valuable assets - data - we make sure that your data as well as your processes around these assets are up to date with the current regulations and guidelines. Validity and accuracy of data  increases stability and performance while improving reusability and maintainability.