Increasingly Challenging Conditions
Today more than ever, pharmaceutical manufacturers are competing in a globally distributed business environment where maximizing efficiency while maintaining high quality is critical. Manufacturing processes are continuously evolving throughout the product lifecycle to align with business and compliance objectives.
Adding to this complexity:
- Information silos within pharmaceutical companies
- Outdated document-intensive processes
- Production increasingly outsourced to CMOs
- Plants manufacturing multiple products
- Production transferring between facilities
As a result, pharmaceutical companies face serious challenges accessing, communicating and acting upon the information needed to support product delivery and quality assurance.
A New Type of PLM Solution
To bridge the communication divides and fill the information voids, Neo PLM has envisioned a new type of PLM software that unites all stakeholders throughout the product lifecycle, from late-stage research through manufacturing.
Whether it’s among internal departments or between pharmaceutical companies and their CMOs, the Neo PLM solution standardizes and enforces consistent process surrounding:
- Recipe management
- Technology transfer
- Manufacturing planning/optimization
From Document-Centric to Design-Centric
In pharmaceutical manufacturing, the process design drives all core business activities. That's why a sophisticated process design module is at the heart of the Neo PLM solution. Stakeholders are empowered with all necessary information from a detailed and highly structured digital process design, eliminating today’s document-intensive work processes.
In essence, Neo PLM enables a science-based approach to managing products throughout their lifecycle.
For pharmaceutical companies, this "science-based" approach provides robust support for the concepts embodied in Quality by Design (QbD) and Process Validation.
TASKS AUTOMATED BY NEO DESIGN
- Time Cycle Analysis
- Material Balance Analysis
- Energy Balance Analysis
- Process Scale-Up Analysis
- Master Recipe Generation
- Batch Instruction Generation
- Production Schedule Analysis
- Batch Review & Analysis
Neo PLM’s Design module tracks all quality attributes and related critical process parameters throughout the product lifecycle.
The Design module integrates with—and configures—third-party execution systems, eliminating the possibility of human error.
Design is integrated with Neo’s analysis tools, ensuring adherence to quality requirements and enabling continuous process improvement.
As in discrete industries, Process PLM is now emerging as a critical manufacturing tool that will empower users to build quality into the design process earlier—replacing “Quality by QC” with “Quality by Design.”