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
Version 1.0 · Version date: 29 August 2026
Q-VALIS products are offered for professional and business use.
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.
Assessed 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.
€380.00Current configured price · Purchasing not yet open
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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 passive course content
Structured explanation
Clear learning units with complete written learning content.
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.
The final assessment contains 30 questions selected from a controlled question bank. A score of 85% is required; because questions carry whole points, the learner must answer at least 26 of 30 questions correctly.
The learner receives three initial attempts. After three unsuccessful attempts, the Final Assessment is blocked until all nine modules are completed again. This required repeat-learning process unlocks two additional attempts, for a maximum total of five attempts without an additional purchase.
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.
What you receive
The complete course and completion evidence
- Online, self-paced professional training course in English
- Nine structured learning modules
- Applied module cases and knowledge checks
- 30-question Final Assessment from a controlled question bank
- Certificate of Achievement after successful completion
- Course Overview / Credential Supplement
- Unique certificate number and downloadable certificate PDF
- Q-VALIS online verification and QR functionality
- Selected downloadable supporting PDF resources
- 12 months access from individual activation
- Technical support via support@q-valis.com
Technical & access requirements
What you need to take the course
- A personal Q-VALIS account and verified email address
- A stable internet connection; offline course completion is not supported
- JavaScript and cookies enabled
- A current supported modern browser
- A desktop or laptop is recommended
- Responsive access is available on tablet and smartphone, but smaller devices are not recommended for completing the full course or Final Assessment
- No additional course software installation is required unless a specific downloadable supporting resource requires it
- Selected supporting resources may be PDF files