Date: November 04, 2025, Online
The requirements for modern and digitalized laboratory informatics are diverse and range from the need for efficiency and usability (paperless laboratory, mobile devices, simplified data exchange, etc.) to growing requirements from regulations and documentation obligations.
Particular attention should be paid to the question of introducing cloud-based components and their specific advantages and disadvantages.
For whom is this seminar important?
- Quality officers
- Quality managers
- Laboratory managers
- IT managers in laboratories
After this seminar
- know the most important requirements for modern laboratory IT.
- know what regulatory requirements there are with regard to IT security.
- know what needs to be considered with cloud-based IT.
- know the advantages and disadvantages of the cloud using practical examples.
Contents:
Introduction Overview
- Requirements for modern laboratory IT:
- Mobility
- Paperless laboratory
- Digitization
- Easy handling
- Simple, controlled processes
- Documentation obligations
- Data exchange with other systems
- Laboratory IT systems:
- What types are there?
Regulatory requirements (with a view to IT security)
- DS-GVO
- ISO 27001
- ISO 17025
- ISO 9001
- Federal strategy for critical infrastructure (KRITIS)
- BSI basic protection manual
- Good Manufacturing Practice (GMP)
- Food Drug Administration: GLP: 21 CFR 58 / GMP: 21 CFR 210 + 211 / Electronic Records and Signatures: 21 CFR 11
- EU EudraLex - Volume 4: GMP Guidelines Annex 11: Computerized Systems
Cloud-based laboratory IT
- Classification of cloud systems -> IaaS, PaaS, SaaS
- Advantages and disadvantages of own data center and cloud solutions
- What do I need to consider with cloud solutions? With regard to IT security, data protection, data location (EU / non-EU -> Privacy Shield (US))
- Validation of computer systems in the cloud
Special challenges
- Separate laboratory networks (old Windows systems in the laboratory)
Concrete examples from practice
- Start-up laboratory company with cloud solutions in the regulated sector
- Open source offers
- Sila2, AniML, BPMN
Date:
04.11.2025
Participation fee: €580.00 (€690.20 incl. VAT)
Online
Link to the event
Contact
Dr. Klinkner & Partner GmbH
Wilhelm-Heinrich-Straße 16
66117 Saarbrücken
Tel +49 (0) 681 / 982 10 - 0
E-Mail: Please click here
Web: http://www.klinkner.de