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ProLeiT AG,
Germany |
Optimazation of revalidation expenditure through the use of the process control system Plant Direct iT ... [more] |
Flexible, reproducible production is of vital importance in the areas of pharmacy, biopharmacy and cosmetics. Our long-term experience in this sector is based on concept development and realization of consistent MES and automation solutions. In close cooperation with our customers and machine and plant suppliers we develop tailored solutions and automation concepts. And also a close contact to renowned universities ensures the innovativeness of our solutions competence for the specific sectors.
Our Plant iT system family meets the requirements with regard to a GMP-compliant system in addition to those set forth in national / international regulations (e.g. FDA 21 CFR Part 11 Electronic Records and Electronic Signatures).
More detailed information on Good Manufacturing Practice based on Plant iT.
We deliver solutions for: - Chemical substance or API production
- Cosmetics
| - Pharmaceutical production
- Biopharmaceutical production
| Sector specific solutions with Plant iT: Incoming goods - Materials management
- Storage administration
- Logistics
Laboratory - Process oriented test procedure
Filling and packaging - Packaging management
- Power Control (OEE)
- Production data management
Auxiliary equipment - Building automation
- Supply engineering
- Energy management
- Package Units
- Gmp-Monitoring
| Production
- Order management
- Recipe management
- manufacturing process
- industrial processes - Weighing and dosing
- automatic
- hand operated - Preparation and mixing systems
- Processing plants (batch or continuous)
- Cleaning (CIP/SIP)
- Logistics (label and barcode handling)
- Tracking & Tracing
- Documentation, reporting
- EBR (Electronic Batch Record)
- Communication
- ERP (SAP, etc.)
- LIMS (Unilab, etc.)'
- scales
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Our solutions are characterized by a high degree of standardization, integration and the avoidance of unnecessary interfaces (Lean vision). The automatic creation of electronic batch records and consistent material tracking throughout the entire manufacturing process are our major goals. The integration of MES and PCS in one single system enables us to achieve high production quality while reducing the system's operating costs. The use of the Plant iT system family has proven its worth for both the migration of legacy systems and the creation of new systems. |
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