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 ensuring data 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 isolated controls to an end-to-end understanding. Integrity takes shape where data is created, processed and retained. This matches QFINITY's conviction that the patient stands at the end of the chain, and it is the patient we owe quality to. Data integrity is therefore not a formality for the auditor but the precondition for sound product and release decisions based on the data.

Data integrity is the prerequisite for every sound decision and the basis on which validation and AI-supported procedures become 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

    Looking at data across its full lifecycle, from creation through processing, storage and use to archiving and deletion, rather than as a snapshot.

  • 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

    Aligning 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)
  • Our contribution demonstrates our data integrity expertise rather than merely asserting it
  • Critical Thinking as a guiding principle throughout
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 core 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 built on it can be relied upon. That is why we anchor data integrity in process and system design, in a risk-based, reconstructable way, with regulatory accountability where it belongs: with the client.

ALCOA++ Data Governance Data Lifecycle Records by Design Risk-based Critical Thinking
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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