Network

The IT Focus Group develops concepts and offers solutions for implementing the regulatory requirements outlined in particular in the EU GMP Annex 11 and FDA 21 CFR Part 11.

Our objectives are:

• Addressing innovative or current IT topics in regulated environments, deepening them in expert discussions, and developing forward-thinking statements for the industry.
• Interpretation and commentary on laws and guidelines related to Computer System Validation (CSV).
• Publication and presentation of the developed results at congresses, seminars, or in publications.

The current focal points include:

• Raw data and data integrity
  • End-to-end process from data capture in laboratory and production to release-relevant data and reports for the QP (Qualified Person).
  • Data migration and archiving
• Mobile Devices and Mobile Applications
  • Validation of Mobile Apps
  • Mobile Device Management and Infrastructure Qualification
• Paperless Lab
  • Establishment of a Paperless Lab considering compliance and validation
• Cloud Computing
  • Opportunities in utilization
  • Contractual arrangements (e.g., Service Level Agreements)
  • Special consideration of validation aspects
  • Project and operational risks
  • Differences from outsourcing
• Electronic Archiving
  • Concepts for data migration and archiving
  • Roles and responsibilities
  • Records Retention

Additional topics include:

• Computer validation
• Auditing of service providers
• Qualification of IT infrastructure
• Electronic documentation
• Electronic signature
• GCP requirements regarding CSV (Good Clinical Practice)
• Serialization
• Industry 4.0 - Impact on compliance

Our activities:

• Idea generator and support for the annual GAMP® 5 Conference
• Organization and conduct of expert meetings on specific topics
• Publications including guidelines, concepts, and commentary on regulatory requirements.

Publications

• Regulatorische Anforderungen an die IT(IL)-Prozesse, Technopharm 2, Nr. 5, 2012
• Server-Virtualisierung im regulierten Umfeld, Technopharm 2, Nr. 5, 2012
• IT meets Processes, Prozesse der pharmazeutischen Industrie und ihre Abbildung in der IT, Technopharm 2, Nr. 5, 2012
• Archivierung elektronischer Daten im GxP-Umfeld,
  Teil 1 Pharmind 72 Nr. 1 (2010),
  Teil 2 Pharmind 72 Nr. 2 (2010),
  Teil 3 Pharmind 73 Nr. 7 (2011)
• APV Empfehlung Elektronische Signaturen, Version 2.0 Dezember 2010