Digital Document Management Instead of a Paper Archive
Healthcare organization 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, because the changeover was not allowed to disrupt existing workflows.
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 organization works paperless with a digital eArchive that reduces manual errors and strengthens the regulatory compliance of its document handling.
Related expertise
Digitalization in Life Sciences →
The eArchive rollout is a classic digitalization 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 Validation (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)
Your project
A comparable project?
Briefly outline your situation. We'll respond with an initial assessment, usually within one business day.
Prefer direct? +49 89 4161170-0
info@theentourage.de
- Reply usually within one working day
- 4 offices: DE · CH · IT · US
- 100% life sciences