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. That is 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 that the patient stands at the end of the chain and that 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. 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). The guide is one of several GAMP guides QFINITY has contributed to (GAMP 5 2nd Edition, the GAMP eClinical Good Practice Guide, "Enabling Innovation"). In three of these guides, Critical Thinking forms the backbone, meaning risk-based judgment instead of working through checklists. 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 of our data integrity expertise, evidence rather than assertion
  • 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
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→ Explore GAMP 5

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

→ Explore CSA

Data integrity with a contributor to the GAMP guide.

We translate ALCOA++, data governance, data lifecycle and records by design, the key concepts of data integrity, 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