B&D Life Sciences

B&D Life Sciences 

Discrete and Flow Manufacturing for the Life Sciences Industry

Business & Decision specialize in implementing discrete and flow manufacturing solutions within the Life Sciences industry, with a focus on the medical devices sector and discrete manufacturing in the pharmaceutical or biotechnology value chain.

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.

In many cases, depending upon the class and type of medical device some companies will require Flow Manufacturing to support the build-to-order manufacturing process, including make-to-stock, configure-to-order, assemble-to-order or engineer-to-order.

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, including product configuration,
  • 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 and 'scrap',
  • Electronic records and signatures (ERES / Part 11).

With fully integrated Financials systems and the ability to leverage additional ERP functionality such as purchasing, inventory and warehouse management, field service, depot repair, quality management and document management, Discrete and Flow Manufacturing Solutions from Business & Decision are also fully able to integrate complex supply chain requirements such as contract manufacturing or packaging and third party distribution and logistics.

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.

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