Data integrity

Get a hands-on approach to ensuring data integrity in your GxP systems, with a focus on practical solutions to maintain compliance. Data integrity in GxP systems has become increasingly important in light of the increased focus of authorities and inspectors in recent years. Our course is based on ISPE's guide "Records and Data Integrity" and GAMP 5, and provides a comprehensive review of how to implement and maintain data integrity in practice.

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Who can participate?

Data owners
Process owners
Project managers
Project engineers
QA employees
Machine suppliers
Robot suppliers
IT suppliers

Course overview

Confirm Knowledge Center
Havnevej 1, 1 tv, 4000 Roskilde
Danish / English

The teaching material will be in English.
Teaching will be in Danish.

Prerequisites to participate

Course Dates Overview

Date and time Location Language Duration Price
December 1, 2026 Confirm Knowledge Center Danish 1 day DKK 5,500 excl. VAT

Read more about the course

Data integrity

In response to increasing scrutiny from regulatory authorities and inspectors, ISPE published the "Records and Data Integrity" guide in 2017, which helps interpret regulatory expectations in light of the industry’s ability to maintain GxP data compliance. The guide is in line with ISPE’s GAMP 5 guide and stands out because it takes all other relevant guides on data integrity into account and incorporates them into a single comprehensive guide.

This course provides a thorough introduction to the guide, with a strong emphasis on practical applications (production, laboratories, IT systems, etc.). Topics covered will include data management, the data lifecycle, risk management, and readiness for inspection. There will be ample opportunity to work with issues and systems from your own daily work, as well as case studies and exercises based on real-world problems.

Course information

Teaching method

The training combines theory with practical exercises and discussions based on the students' own experiences and challenges. We value learner feedback to ensure continuous improvement of our courses.

We will be doing exercises on the Data Integrity Maturity Model, the Data Life Cycle, and risk assessment with a focus on data integrity. The instructor will guide participants through the exercises, answer questions about data integrity that arise in your daily work, and offer advice on how to improve.

Course highlights

On the course you will achieve:

Thorough understanding of ISPE's guide "Records and Data Integrity"
Competencies for active participation in data integrity work, including risk assessment and preparation for inspection
Knowledge of how to minimize the risk of data loss and ensure efficient design and maintenance of regulatory data

Course program

Key terms and definitions
Regulatory requirements and focus, including culture, procedures and technology
Framework for good data integrity and key activities
Risk assessment and identifying weak points in your own system
Inspection readiness and audit trails
Data integrity in the IT context and data integrity requirements in the URS
Archiving, migrating and managing hybrid systems

After the course

Instructor on the course

Jeppe Lunde Schmidt

Jeppe works in our validation team on a daily basis. He has GMP experience from several large remodeling projects in pharmaceutical packaging plants and countless validations of everything from simple transmitters to large complex IT systems. He has produced and read a wide variety of documentation and has visited companies and sites across the country. He has worked with manufacturers of both pharmaceuticals and medical devices and incorporates his experience in the industry into his teaching. Jeppe has several years of teaching experience and teaches several of our other courses, including GAMP5 and Data Integrity.

Testimonials from learners

Course participant in Introduction to GAMP 5
Really good and professionally strong presentation. The trainer found the right professional level for the group and initiated good tasks and resulting discussions. And super with small breaks every hour.
Course participant in Introduction to GAMP 5
Many thanks and much praise to Katrine! As a teacher, you are present, relevant, a skilled communicator and very pleasant. You manage to bring your experience from both teaching and practice into play in the context in which we ask the questions.
Course participant in Introduction to GAMP 5
I think it was good to mix the theory and the practical part. The teacher was super good at explaining and super good at pulling out examples that supported the theory.
Course participant in Data Integrity
The benefit of the course is a quick and processed approach to the ISPE guide.
Course participant in Data Integrity
It was a great course that lived up to all expectations. Super good teacher 🙂
Course participant in Data Integrity
Really good course... even after many hours you are still in it... course leader can maintain focus and interest
Student in SattLine Programming
A good structure of course material and balance between theoretical material and exercises. The theoretical parts gives food room for more in depth questions of interested.
Student in SattLine Programming
Very motivated course-responsible, very pationate and patient.
Course participant in Data Integrity
Good with exercises and quizzes. Good location and delicious food/catering.
Student in SattLine Programming
Super teacher 👍😁

Do you have any questions?

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