209 - ALCOA++ EXPLAINED | What Everyone Gets Wrong About Data Integrity with Monika Andraos

Let's Combinate - Drugs + Devices

In this episode, I talk with Monika Andraos of Dunamis Compliance about how organizations can navigate group think and approach data integrity the right way.

We cover risk culture, CSV vs. data integrity, ALCOA++, data governance, and practical tips for newcomers.

Key topics include:

• Encouraging diverse perspectives to combat group think

• Why data integrity is broader than CSV

• The pyramid structure: data integrity at the top, CSV & validation as elements

• ALCOA++ and traceability in real-world systems

• Practical CSV and validation workflows

• Common audit pitfalls and how to strengthen governance

⏱ Timestamps

00:00 – Intro: Group Think & Risk Appetite

00:41 – Data Integrity in Consulting

01:41 – Encouraging Diverse Perspectives

02:37 – CSV vs Data Integrity

03:13 – The Role of Data Stewards

03:54 – The Pyramid: Data Integrity, CSV & Validation

04:45 – ALCOA++ and Core Data Integrity Elements

13:59 – Real Examples: CSV & Validation Workflows

17:40 – Common Audit Pitfalls & Data Governance

22:50 – Advice for Newcomers + Wrap-Up

Monika is the Principal at Dunamis Compliance. She has over a decade of experience in formulating and executing strategies for data integrity and data governance assessments and remediation, risk management and computerized system validation within the pharmaceutical sector. She has worked within Quality, Technical Operations, Automation and Regulatory Affairs to execute and deliver compliant system solutions in regulated GXP environments.