Date: September 23, 2026
Online
The digitization of processes is increasingly taking place in GxP-regulated areas as well. As a result, the use of computer-based systems is becoming increasingly important for GLP testing facilities. Today, it is no longer possible to conduct GLP tests without IT and electronic data management.
OECD Document No. 17, “Application of GLP Principles to Computerized Systems,” sets a standard here that is also applicable to other GxP areas (e.g., GCP, “GCLP”) and to bodies accredited according to ISO/IEC 17025 or ISO 15189.
The seminar presents concepts for the categorization, validation, and operation of computer-based systems (IT systems), highlights regulatory requirements, and addresses many practical aspects of using computerized systems under GLP conditions.
Terms and Conditions:
You can find all information regarding reservations, registration, event materials, and certificates of attendance in our Terms and Conditions for Open Events.
The seminar is intended for anyone who
work in GLP areas as test personnel, test managers, quality assurance staff, IT managers, archive managers, or test facility managers.
work in GxP or accredited areas and are confronted with quality requirements for computer-based systems.
Program, configure, or validate software for GxP areas, e.g., for LIMS applications, device interfaces, or data analysis.
Use custom software or Excel applications under GxP or accredited conditions.
Review computer-based systems and their validation during audits and inspections.
After attending this seminar
You will understand the concept of the system life cycle.
You will be familiar with the V-model for validation.
You will learn which phases of computer-based systems require written procedures (e.g., SOPs) and qualification or validation.
You will be familiar with the basic content and requirements of OECD Document No. 17.
you will know what you need to consider when handling and archiving electronic data under GLP.
you will be familiar with the expectations and requirements of (GLP) inspectors regarding the use of computer-based systems
Program
The document “OECD No. 17 – Application of GLP Principles to Computerized Systems”
The Life Cycle Concept
Risk Management
Quality Management System
COTS Products (commercial off-the-shelf)
Data Integrity
Audit- and inspection-ready processes: 7-point plan
IT Strategy
IT Landscape (Inventory, Overview)
Personnel and Responsibilities
System and Use Case Documentation
Validation Concepts
IT Infrastructure Operations (Maintenance, Change Management, Data Backup, Disaster Recovery, …)
Archiving
Handling Electronic Data in a Regulated (GLP) Environment
Raw data and processed data
Data formats for long-term archiving
Concepts for an electronic archive
Challenges (including electronic signatures)
Examples, Questions, and Answers
For more information:
Date:
September 23, 2026
Registration fee: €610.00 (€725.90 incl. VAT)
Online
Contact
Dr. Klinkner & Partner GmbH
Wilhelm-Heinrich-Straße 16
66117 Saarbrücken
Tel +49 (0) 681 / 982 10 – 0
Web: http://www.klinkner.de