Label software for pharma & life sciences
Pharma is the most heavily regulated labeling sector in the world. GxP, DSCSA, EU FMD, non-compliance is not an option. Labels en Meer delivers compliance by design.
What sets us apart in this sector
21 CFR Part 11
Audit-proof label control with full traceability, electronic signatures, and approval workflows.
EU FMD serialization
Aggregation, randomization, and EMVS uploads, integrated into your Loftware Cloud production flow.
Multi-language labels
One template, automatic localization to the languages and regulations of your target markets.
Challenges we solve
GxP & 21 CFR Part 11 compliance
Full audit trail with electronic signatures. Every label change documented with who, when, and why — ready for FDA inspections.
Serialization & traceability (DSCSA/EU FMD)
Integrated serialization with unique identification codes per package. Direct coupling with track-and-trace systems.
Change management for labels
Controlled approval process for label changes with version control, review cycles, and automated notifications.
Results in your industry
100%
Audit trail coverage
A pharmaceutical company (250 employees) passed an FDA audit without findings after Loftware Business captured the complete label history and approval flows.
-85%
Time for label changes
Change management workflow reduced the lead time for label changes from an average of 3 weeks to 2.5 days — without compliance risk.
€0
Recall costs from label errors
No more product recalls due to incorrect labels. Serialization checks catch errors before packaging — not later in distribution.
Ready to transform your labeling?
Schedule a free 30-minute demo. Our specialist will show you how Loftware Cloud fits your situation.