Description
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.
Target audience: Anyone who
- who work in GLP areas as study personnel, study managers, quality assurance staff, IT managers, records managers, or heads of the testing facility.
- who are required to comply with quality requirements for computer-based systems in GxP or accredited areas.
- Program, configure, or validate software for GxP environments, such as 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 understand what the concept of the system life cycle means.
- you are familiar with the V-model for validation.
- You have learned which phases of computer-based systems require written procedures (e.g., SOPs) and qualification or validation.
- you are familiar with the basic content and requirements of OECD Document No. 17.
- you know what you need to keep in mind when handling and archiving electronic data in accordance with GLP.
- You are familiar with the expectations and requirements of (GLP) inspectors regarding the use of computer-based systems.
You can find a complete overview of the event here.
