INDUSTRY 01/04
Faster batch release
Without compromising GxP
Automation, data and validation for pharmaceutical and biopharmaceutical manufacturing, from greenfield fill-finish to legacy upgrades.
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Why Réalta
Pharma is where Réalta was built. We work with 8 of the top 12 global pharmaceutical companies and have delivered across the full lifecycle: commissioning greenfield fill-finish facilities, integrating plants end to end, and upgrading business-critical systems inside shutdown windows. Our engineers understand GxP because they work in it every day.
The Pressures You Face
Pharmaceutical manufacturers are under pressure to increase output and bring new products to market faster, while regulators scrutinise data integrity more closely than ever.
- Batch release slowed by paper records and manual review
- Data trapped in islands of automation and point-to-point interfaces
- Ageing, business-critical systems that are hard to upgrade without re-validation
- Capacity expansion and new modalities that must be commissioned right first time
How We Help
Batch release acceleration
Review by exception, validated electronic batch reports and EBR integration.
Plant data infrastructure
Historians, Unified Namespace and integration with MES, LIMS and the cloud, for greenfield and brownfield sites.
Batch and process analytics
Golden batch, cycle-time and variation analysis, and PAT data that is ready for modelling.
Automation and C&Q
DeltaV and PLC/SCADA engineering, commissioning and qualification, including fill-finish.
Data integrity and CSV
Part 11 and Annex 11 readiness, ALCOA+ assessments and GAMP 5 validation.
Regulatory landscape we work within
We work with sites inspected by the FDA, EMA, HPRA and MHRA.
- EU GMP (EudraLex Volume 4) including Annex 1 and Annex 11
- FDA 21 CFR Parts 210
- 211 and 11, ICH Q8 to Q10
- GAMP 5 and ALCOA+
Our Technologies & Partners
Tursted across regulated manufacturing
works across a broad range of industrial automation platforms and technologies, including:
Insights and Perspectives
Ideas for more connected
manufacturing
Technical insight, practical guidance and real-world thinking from Réalta specialists.
REALTED CASE STUDIES
PHARMACEUTICAL
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UNITED STATES
+1 302 509 4401
IRELAND
+353 21 243 9113
GLOBAL CAPACITY
Ireland - Unites States - India