NNE’s automation and IT experts hold key knowledge and experience within the implementation and validation of automation and IT solutions at all levels of pharmaceutical manufacturing. Whether you are building a new facility and need a facility-wide automation and IT system or simply need to upgrade or replace an existing automation and IT solution, NNE can help.
We continuously work to explore new systems and challenge the existing ones. Our close cooperation with major vendors secures the choice of the best solution.
Our goal is to ensure that your automation and IT solutions aid you in driving compliance, performance, quality and profit margins and leveraging lean strategies.
NNE’s project and Good Manufacturing Practice (GMP) experience ensure that your automation and IT solution fits your needs. Our global experience and methodology lets you take a pragmatic approach to implementing your solutions.
Our automation and IT implementations know-how and services cover:
- Recipe and batch management/reporting
- Process control systems (DCS/SCADA/PLC)
- Manufacturing execution systems (MES)
- Electronic batch documentation (EBR, EDM) systems
- Data collection and analysis (Historian, KPI, OEE)
- Manufacturing intelligence systems
- Process monitoring and alarm handling
- Data collection and visualization (historian)
- Advanced control and optimization
- Performance monitoring (OEE)
- Process analytical technology (PAT)
- Facility monitoring systems (FMS)
- MIT custom application development
- Laboratory automation and LIMS systems
- Production planning and scheduling and systems
- Automated material and warehouse management systems
- Support with process specifications and descriptions
- Functional specifications (processes) according to ISA-88
- Handling of sub-suppliers
- System infrastructures/virtualisation
Quality and validation services
- Enhanced design review (EDR)
- Risk analysis and impact assessment
- Factory and site acceptance and test (FAT/SAT)
- Commissioning and qualification (IQ, OQ, PQ)
- Standard operating procedures development (SOP)
- Good engineering practice (GEP)
- cGxP consulting, including 21CFR11 gap analysis
- Quality activity planning
- Good test and documentation practice (GTP/GDP)
- Supplier audit and inspection
Effective management of your automation and IT projects
At NNE we have dedicated automation and IT project managers, who can successfully execute your automation and IT projects. We understand the nature of implementing strategic business/IT projects as well as fast-track projects.
At NNE , we offer automation and IT project management with:
- Traditional project management
- Agile project management
- Project portfolio management
- Project governance
- Vendor management
- Risk management
- Change management
- Managing work sharing and corporation cross site, cultures and time zones
- We possess certifications within PMI, PRINCE2, IPMA and SCRUM