Date: October 23, 2024, Online
The requirements for a modern and digitalized laboratory informatics are manifold and range from needs of efficiency and operability (paperless lab, mobile devices, simplified data exchange, etc.) to growing requirements from regulations and documentation obligations.
The question of an introduction of cloud-based components and their specific advantages and disadvantages deserves special attention.
For whom is this seminar important
- Quality representatives
- Quality managers
- Heads of laboratories
- IT managers in laboratories
After this seminar
- know the most important requirements for modern laboratory IT.
- know what the regulatory requirements are with regard to IT security.
- know what to look out for in 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, guided processes
- Documentation requirements
- Data exchange with other systems
- Laboratory IT Systems:
- What are the species?
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: Computerised Systems
Cloud-based laboratory IT
- Classification of cloud systems -> IaaS, PaaS, SaaS
- Advantages and disadvantages between own data center and cloud solutions
- What do I have to consider with cloud solutions: With regard to IT security, data protection, location of data (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 offerings
- Sila2, AniML, BPMN
Date:
October 23, 2024
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