Digital Document Management Instead of a Paper Archive
Healthcare organisation with paper-based document storage
The continued use of paper-based document storage caused inefficiencies and compliance risks.
The challenge
The situation
The continued use of paper-based document storage led to considerable inefficiencies and compliance risks. A digital document management system was needed to streamline operations, reduce manual errors and ensure regulatory compliance, without disrupting existing workflows.
Our approach
What we delivered
Introduction of a digital eArchive for document storage
Training of end users for the new digital workflows
Upfront risk assessment to secure the transition
The outcome
Results & impact
Paperless storage
Complete replacement of paper-based document storage.
Smooth transition
Migration without disruption to existing workflows.
Reduced compliance risks
Lower compliance risks from manual document handling.
In summary
The organisation works paperless with a digital eArchive that reduces manual errors and strengthens the regulatory compliance of its document handling.
Related expertise
Digitalisierung Life Sciences →
The eArchive rollout is a classic digitalisation project addressing the GMP-compliant replacement of paper-based processes by digital systems.
Data Integrity Assurance →
The move from paper to digital document management directly touches data integrity per ALCOA+, which had to be ensured during the compliance checks.
Computer System Validierung (CSV) →
Integrating the new eArchive system into the IT infrastructure requires GMP-compliant validation per GAMP 5, as carried out in the project.
Business, Data & IT →
Building a GxP-compliant, validated IT landscape was a central prerequisite for the seamless migration to digital document management.
Sources
- Entourage project experience (anonymised)
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