Data integrity - GAMP RDI Key Concepts - QFINITY
QFINITY · ISPE GAMP RDI · Publication

Data Integrity - Key Concepts.

The GAMP RDI Good Practice Guide "Data Integrity - Key Concepts" (ISPE, October 2018) lays the foundations for handling data with integrity in regulated environments. QFINITY contributed to this guide - direct evidence of our data integrity expertise, not a topic claimed after the fact.

Get in touch The key concepts
The guide

Data integrity as a foundation, not a control step.

The guide belongs to the GAMP RDI (Records and Data Integrity) Good Practice Guide family and shifts the focus from point controls to a continuous understanding: integrity takes shape where data is created, processed and retained. This aligns with QFINITY's stance - the patient stands at the end of the chain, and we owe the patient quality; data integrity is therefore not a formality for the auditor but the precondition for sound product and release decisions based on the data.

Data with integrity is the prerequisite for every sound decision - and the basis that makes validation and AI-supported procedures viable in the first place.
The fundamentals

Five key concepts of data integrity.

These five terms are part of the established foundation of data integrity in the GxP industry - independent of any single guide, and we work with them in every engagement.

  • ALCOA++

    The attribute set for data with integrity: Attributable, Legible, Contemporaneous, Original, Accurate - supplemented by Complete, Consistent, Enduring, Available and Traceable.

  • Data Governance

    Organizational responsibility, policies and culture for handling data across the entire lifecycle - not a single control but a job for leadership.

  • Data Lifecycle

    Consider data from creation through processing, storage and use to archiving and deletion - not as a snapshot but across the full lifecycle.

  • Integrity as a design property

    Records by design: integrity is built into process and system design instead of being checked after the fact.

  • Risk-based approach

    Align the depth of control with data criticality and risk - mirroring the GAMP risk logic rather than applying uniform controls to all data.

A contributor to the guide

QFINITY in the GAMP RDI Good Practice Guide.

Oliver Herrmann helped create the GAMP RDI Good Practice Guide "Data Integrity - Key Concepts" (ISPE, 2018) - one of several GAMP guides QFINITY has contributed to (GAMP 5 Second Edition, the GAMP eClinical Good Practice Guide, "Enabling Innovation"). In three of these guides, critical thinking forms the backbone - risk-based judgment instead of working through checklists; and that signature is exactly what we bring to our clients' data integrity work.

  • Contributed to the creation of the GAMP RDI GPG "Data Integrity - Key Concepts" (2018)
  • Contributor role as evidence for the DI pillar - proof, not just a claim of expertise
  • Critical thinking as a consistent principle
Cleanroom corridor with a continuous light trace - data integrity across the full lifecycle
View the GAMP RDI Good Practice Guide in the original at ISPE↗
From guide to practice

Data integrity as a load-bearing pillar.

Data with integrity is the basis for reliable validation and for every AI-supported procedure: if the underlying data lacks integrity, neither a test result nor a model can stand on it. That is why we anchor data integrity in process and system design - risk-based and reconstructable, with regulatory responsibility where it belongs: with the client.

ALCOA++ Data Governance Data Lifecycle Records by Design Risk-based Critical Thinking
More from the service areas

From guide to everyday practice.

Data Integrity

How we translate ALCOA++, data governance and the data lifecycle into compliant, reconstructable practice - EU and FDA.

→ Explore data integrity

GAMP 5 Second Edition

The risk-based framework for computerized systems - a guide whose core team QFINITY was part of.

→ Explore GAMP 5

Computer Software Assurance

The FDA guidance for risk-based assurance of production and QMS software - effort scaled to Intended Use and process risk, consistently tied to data criticality.

→ Explore CSA

Data integrity with a contributor to the GAMP guide.

We translate the key concepts of data integrity - ALCOA++, data governance, data lifecycle, records by design - into a risk-based, audit-ready practice for your systems. Free initial consultation, about 30 minutes, directly with a contributor to the guide.

Arrange an initial consultation