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.

Our solutions

your benefits

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.

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Meet our expert

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Anne Woitzik

Senior Manager Quality & Compliance

Anne Woitzik is a highly experienced Life Science sector consultant possessing an extensive European and US experience, where through the various positions she held, she gained an exposure to many of the key areas and specializations that constitute the operational backbone of the Healthcare Industry.With clients such as the Roche Diagnostics Corporation in the US, Roche Diagnostics in Germany, Fresenius Kabi, in Germany, Italy and Poland, Boehringer-Ingelheim and BASF Personal Care & Nutrition GmbH, Anne honed her skills and gained a 360° grasp of the Healthcare sector. Holding key senior positions, she acquired hands on International Quality Management and Regulatory Affairs experience within the Pharmaceutical and Medical Device industry, and became a CSV and Quality Management specialist with a focus on Data Integrity and Risk Management. She was also a GMP Compliance and CSV/GAMP 5 trainer during a large-scale global SAP roll-out for Fresenius Kabi. Anne holds an MBA at the ESEI International Business School Barcelona, and BA in International Business at the Cooperative State University Baden-Wuerttemberg.