Discrete manufacturing is primarily used by

Medical device companies and is suitable for high volume or low volume/high technology devices of all classes.

Pharmaceutical / biotechnology companies involved in small lots, secondary manufacturing and packaging or pharmacotherapeutic products.

Our Discrete Manufacturing Solutions

Solutions are based upon Enterprise Resource Planning (ERP) systems from Business & Decision's software partners and leverage best practice such as lean manufacturing and six-sigma. Solutions from Business & Decision incorporate the need for Life Sciences organizations to address complex manufacturing issues such as:

 

Advanced planning and scheduling	Mobile solutions
Complex bill of materials	Warehouse management
Lot splitting and sub-lots	Shop-floor integration (MES)
Device traceability (including device serialization)	Production equipment maintenance and validation
Variable yield	Device History Record (DHF / DHR)
Rework	Electronic records and signatures (ERES / Part 11)

Implemented using industry best practice accelerators, all solutions comply with relevant Good Manufacturing Practice (GMP) regulations including 21CFR Part 820 and ISO 13485. Solutions are validated as an integral part of Business & Decision's defined implementation life cycle.

Other Key Areas within the Manufacturing and Supply Chain

• Process manufacturing solutions
• Quality assurance solutions

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