Why digital document management is crucial in the GMP environment.
In a regulated environment, a classic folder structure is no longer sufficient. GMP document management requires clear processes, complete traceability and robust CSV validation. This is the only way for companies to be on the safe side during audits, inspections and audits by the authorities.
Practical example: eArchive at the Basel Blood Donation Center.
Using a specific project at the Basel Blood Donation Center, we show how a digital archive can be set up from the initial requirement to the validated go-live. The system is audit-proof, audit-compliant and designed for long-term operation - a model for all regulated organizations.
Your learnings from the event.
- How requirements from GMP and CSV can be translated into a viable eArchive concept
- Which steps are particularly critical during implementation - including pitfalls and best practices
- How efficient CSV validation succeeds and is sustainably anchored in the company
Who benefits from the event.
The event is aimed at quality, IT and CSV managers in pharmaceutical companies, medical technology, biotechnology, blood donation services and laboratories who want to introduce a digital archive or modernize existing systems.
Event details.
📅 S eptember 25, 2025
🕚 11:00 - 11:45 a.m.
💻 Online | Free of charge | German
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