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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-10-08
- Length: 22m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-08-209-alcoa-explained-what-everyone-gets-wrong-about-data-integrity-with-monika-an
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/209---ALCOA-EXPLAINED--What-Everyone-Gets-Wrong-About-Data-Integrity-with-Monika-Andraos-e394bv5

## Summary

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.

## Chapters

- [0:06](https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-08-209-alcoa-explained-what-everyone-gets-wrong-about-data-integrity-with-monika-an#t=6) Introduction: Group Think and Risk Appetite in Compliance
- [1:17](https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-08-209-alcoa-explained-what-everyone-gets-wrong-about-data-integrity-with-monika-an#t=77) Combating Group Think by Consulting Floor SMEs
- [2:38](https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-08-209-alcoa-explained-what-everyone-gets-wrong-about-data-integrity-with-monika-an#t=158) Distinguishing Data Integrity from CSV Activities
- [3:54](https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-08-209-alcoa-explained-what-everyone-gets-wrong-about-data-integrity-with-monika-an#t=234) The Data Integrity Pyramid and Stakeholder Roles
- [6:28](https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-08-209-alcoa-explained-what-everyone-gets-wrong-about-data-integrity-with-monika-an#t=388) Defining ALCOA++ and Core Data Attributes
- [6:44](https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-08-209-alcoa-explained-what-everyone-gets-wrong-about-data-integrity-with-monika-an#t=404) Validating GXP Systems and Vendor Management
- [10:18](https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-08-209-alcoa-explained-what-everyone-gets-wrong-about-data-integrity-with-monika-an#t=618) Example of Lab Instrument Validation and LIMS Integration
- [14:01](https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-08-209-alcoa-explained-what-everyone-gets-wrong-about-data-integrity-with-monika-an#t=841) Common Audit Pitfalls: Missing Specs and Audit Trails
- [16:53](https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-08-209-alcoa-explained-what-everyone-gets-wrong-about-data-integrity-with-monika-an#t=1013) Data Governance and Regulatory Frameworks (21 CFR Part 11, PIC/S 41)
- [21:50](https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-08-209-alcoa-explained-what-everyone-gets-wrong-about-data-integrity-with-monika-an#t=1310) Advice for Newcomers: Training and Active Participation

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

early-stage companies

## Mentioned

- Dunamis Compliance (company)
- LIMS (tool)
- 21 CFR Part 11 (other)
- PIC/S 41 (other)
- GAMP 5 (other)

## Related episodes from other shows

- [#384: Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-09-26-384-insights-from-an-ex-fda-investigator-compliance-quality-systems-and-medtech) (Global Medical Device Podcast)
- [What are the Top Compliance Issues Plaguing Medical Device Manufacturers?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-10-what-are-the-top-compliance-issues-plaguing-medical-device-manufacturers) (Global Medical Device Podcast)
- [For the Love of Internal Auditing](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-26-for-the-love-of-internal-auditing) (Global Medical Device Podcast)
- [Common QMS Mistakes SaMD Companies Make](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-21-common-qms-mistakes-samd-companies-make) (Global Medical Device Podcast)
- [#360: Is It Possible to "Buy" a QMS?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-11-360-is-it-possible-to-buy-a-qms) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-08-209-alcoa-explained-what-everyone-gets-wrong-about-data-integrity-with-monika-an. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.