Life Sciences Industry
Research & Development
Expand Flexibility
Our Research and Development Management solution sets the heartbeat for future manufacturing of pharmaceutical products. This system provides for user-oriented support regarding the development and definition of formulation and production procedures for drug substances and diagnostics.
Case In Point
- Industry client — Global player in the pharmaceutical industry.
- Objective — GMP compliant recipe development system for complete warehouse management and electronic production documentation in the weighing process.
- Results — Increased research and development throughput by more than 20%, with recipe data sets conditioned for direct transfer to clinical trial department
Drivers and Challenges
Costs. Substantial support of all tasks relevant during the research and development phase allows for higher exploitation of the available human resources. The consequent relocation of personnel power from organization and preparation towards creativity and ingenuity reinforces productivity and thus promotes a considerable cost reduction.
Time-to-market. Easy and quick creation of master data, template-like support via recipe matrix, and minutely recording of process data are example features which drive innovation during the prototyping phase. The process-specific facilitation contributes to an optimization of the development chain and thus shortens time-to-market.
Regulatory compliance. Validated documentation management and archiving features of the integrated IT solution trim your workflow in accordance with cGLP and cGMP standards. Version control, check-in/out, and electronic batch recording (EBR) improve traceability and thus advance your compliance efforts.