Good Documentation Practice (ALCOA+)

📝 Good Documentation Practice (ALCOA+) – Training

✅ Document Right. Maintain Integrity. Ensure Compliance.

📘 Course

Description

This training provides a comprehensive understanding of Good Documentation Practice (GDP) and its critical role in maintaining data integrity in GMP-regulated environments.
It is based on ALCOA+ principles — ensuring data is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available — as required by FDA, EU GMP, WHO, PIC/S, and MHRA guidelines.

Participants will learn how to apply GDP in paper-based, hybrid, and electronic systems, integrate GDP into Quality Management System (QMS) processes, and avoid common documentation errors that lead to regulatory findings.

Module 1

Regulatory Expectations for GDP

FDA, EU GMP Annex 11 & 15, WHO, PIC/S, MHRA Guidance

GDP vs Data Integrity – Key Links

Module 2

ALCOA+ Principles in Practice

Attributable – Linking Data to the Individual

Legible – Ensuring Readability and Clarity

Contemporaneous – Recording in Real Time

Original – Maintaining the True Record

Accurate – Reflecting the True Result

Complete, Consistent, Enduring, Available – Extended Principles

Module 3

GDP in QMS Processes

Batch Records, Logbooks, and Laboratory Notebooks

Change Control, Deviations, CAPA Documentation

Validation & Qualification Records

Module 4

Common Pitfalls & Best Practices

Avoiding Backdating, Overwriting, and Unauthorized Corrections

Ensuring Audit Trail Compliance in Electronic Systems

Case Studies of Regulatory Observations

📢 Register Today – Strengthen Documentation Practices to Support Data Integrity and GMP Compliance!