Hardware Podcasts

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

Let's Combinate · 8 Oct 2025 · 22m

What this episode covers

Monika Andraos, Principal at Dunamis Compliance, explains that data integrity is a broad governance goal, not just a Computerized System Validation (CSV) activity, and must be designed into processes from the start. She details the ALCOA++ framework (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete and Traceable) and argues that organizations must combat group think by actively seeking input from floor-level Subject Matter Experts (SMEs) rather than relying on prescriptive regulations. Andraos highlights common audit pitfalls, such as vendors claiming GAMP 5 compliance without providing design specifications or audit trails, and emphasizes that data stewards, not just IT, are responsible for maintaining data quality in systems like LIMS.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Dunamis Compliance
Tools
LIMS
Also
21 CFR Part 11, PIC/S 41, GAMP 5

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