EU GMP Part I — Chapter 4
Documentation: creation, approval, control, recording, correction, retention and availability of GMP documents and records.
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EU GMP pharmaceutical training · Online course
EU GMP - Good Documentation Practice & Data Integrity
Interactive, scenario-based training on Good Documentation Practice and Data Integrity within the European pharmaceutical GMP framework, for professionals who create, review, manage or rely on regulated records and data.
Certificates compatible with
European Digital Credentials for Learning
European Digital Credentials for LearningAssessed professional course
This is an assessed professional course. The certificate is not awarded for viewing the content alone. Learners must complete the required activities and demonstrate their understanding through applied knowledge checks and a final assessment.
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Enrollment unavailablePreview a course screen
Course overview
Reliable records. Trustworthy data. Better decisions.
Good documentation is not an administrative formality. It is the evidence that work was performed correctly and that decisions can be reconstructed, reviewed and trusted.
This course introduces the essential principles of Good Documentation Practice and Data Integrity through concise explanations, knowledge checks and realistic situations. It is designed to help learners recognise weak practices, understand their consequences and make sound decisions in their everyday work.
Regulatory basis
Grounded in the European pharmaceutical GMP framework
The course is based primarily on the applicable principles and requirements of EudraLex Volume 4 — the EU Guidelines for Good Manufacturing Practice for medicinal products for human and veterinary use.
EU GMP Annex 11
Computerised Systems: controls relevant to electronic records, security, accuracy, audit trails, changes and data retention.
EU GMP Part I — Chapter 6
Quality Control requirements relevant to laboratory documentation, raw data, records, review and traceability.
EMA GMP/GDP Q&A
European regulatory expectations concerning data lifecycle management, ALCOA principles and controls for paper and electronic records.
PIC/S PI 041-1
Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments, used as complementary inspection guidance.
Terminology note
In the title of this course, “GDP” means Good Documentation Practice. The course is not a Good Distribution Practice course.
The complete reference list and the editions applicable to the course version will be stated in the final syllabus before purchase.
AI-assisted production disclosure
Transparent use of AI-assisted tools
AI-assisted tools were used in the development of this course for software development and technical configuration, the creation of certain fictional images and visual elements, and language editing.
The regulatory interpretation, selection and explanation of sources, course structure, practical cases, assessment content and final editorial review are the responsibility of Emil Mitev and IC GLOBALTEST OOD. No course content is published without human review and approval.
AI-generated visual examples do not depict authentic records, persons or events unless expressly stated otherwise.
Who this course is for
Designed for people responsible for reliable information
- Laboratory and quality-control personnel
- Quality assurance and compliance professionals
- People who create, review, approve or retain regulated records
- Managers responsible for data, documentation or staff competence
- Professionals entering a GMP or other regulated working environment
Learning experience
More than slides and a voice-over
Structured explanation
Clear learning units with voice-over and a complete written transcript.
Knowledge checks
Questions throughout the course keep the learner actively involved.
Applied cases
Realistic decisions connect the requirements with professional practice.
Final assessment
A documented assessment confirms successful understanding of the material.
Assessment & certificate
Clear rules before you enrol
This is an assessed professional course. The certificate is not awarded for viewing the content alone. Learners must complete the required activities and demonstrate their understanding through applied knowledge checks and a final assessment.
A score of 85% is required for successful completion.
The learner receives three assessment attempts. If required, the course may be completed again before two additional attempts become available.
The certificate confirms successful completion only; it does not display the assessment score. It includes the learner’s name, course title, issue date, unique number and QR verification code, followed by a one-page Course Overview.
Technical requirements
What you need to take the course
A current web browser, a stable internet connection, speakers or headphones, and a personal email address are required. The course is intended to work on current versions of Windows and macOS and on modern tablets. A laptop or desktop computer is recommended for the best learning and assessment experience.