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GDocP In development

Good Documentation Practice and Data Integrity

ALCOA+ in daily work: recording, correcting and reviewing records on paper and in electronic systems.

Duration
1.5 hours
Level
Foundation
Lessons
6 lessons

This course is being written now

Good Documentation Practice and Data Integrity is in development. Waitlist members receive the launch price, an early look at the curriculum and a chance to tell us which situations from their own site the course should cover.

What this course does and does not do

Covered

  • ALCOA+ applied to paper and electronic records
  • Corrections, blank forms, logbooks and issuance control
  • Second-person review, audit trail review and retention

Not covered

  • Validating or configuring your computerised systems
  • Your document management system or its administration
  • A data integrity remediation plan for a specific finding

This course is professional training. It does not replace your site’s procedures, and it is not regulatory or legal advice on a specific event.

Who it is for

  • Everyone who signs a GMP record
Before you decide

Do you really need this course?

10 questions from real inspection findings. Three minutes. No sign-up.

Not started

Ten questions about the records you produce every day. Data integrity is the single most common theme in recent inspection findings. Nobody sees your answers.

For managers

Rolling good documentation practice and data integrity out to a team?

The Site Readiness Programme adds a team heatmap from the self-assessment, a live session on the weakest questions, and records named by employee ID. Quote within two working days.

  • Seats for the whole team, with licences from ten seats
  • Anonymised team heatmap: which questions your people fail, by chapter
  • 90-minute live session built on the team's weakest questions
See the programme

Regulations referenced

  • EU GMP Chapter 4
  • EU GMP Annex 11
  • PIC/S PI 041

Continue the path

DEVPractitioner
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Deviation Management Essentials

Detect, document, investigate and close deviations the way inspectors expect to see them, with clear ownership and defensible impact assessments.

6 lessons · knowledge checks · scored final exam

CCPractitioner
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Change Control Essentials

Plan, assess, approve and verify changes to facilities, equipment, materials, processes and systems without losing control of the validated state.

6 lessons · knowledge checks · scored final exam