AZAVAI GxP Academy
← Back to catalogue

School of Data Integrity

Data integrity and ALCOA+ in GxP environments

Connect requirements to quality decisions and expected evidence.

Decision to master

Assess a data situation against ALCOA+ and define the evidence required for reliability.

Learning objectives

  • Explain the quality intent associated with "Data integrity".
  • Identify the risks, responsibilities and evidence expected in a professional situation.
  • Formulate a proportionate, traceable and defensible decision.

Indicative programme

  1. ALCOA+ principles and regulatory expectations (FDA, EMA, PIC/S)
  2. Data governance: lifecycle, access control, audit trail
  3. Critical risks: deletion, modification, backdating
  4. Scenario: assess reliability of a data set

Prerequisites

  • GMP fundamentals and quality system (or equivalent experience)