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. The replacement had to cut manual effort, reduce errors and maintain 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 →
Paperless manufacturing and the GMP-compliant replacement of paper-based processes
Data Integrity Assurance →
Data integrity procedures and audit trail review in GxP systems to ALCOA+
Computer System Validation (CSV) →
Risk-based validation under GAMP 5 and EU GMP Annex 11
Business, Data & IT →
Technology strategy, system selection and validation of GxP-regulated IT
Sources
- Entourage project experience (anonymized)
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