Mixed Mode Manufacturing

Business & Decision uses specialist knowledge of process, discrete and flow manufacturing solutions to provide Mixed Mode manufacturing solutions for Life Sciences clients.

For a number of larger Life Sciences customers there is the need to support multiple modes of manufacturing - process, discrete and/or flow. The move to gain cost advantage by leveraging a single ERP system (single instance) drives such companies to develop solutions that provide a world-class solution in all manufacturing regimes, across multiple business units. For smaller organizations, the unique nature of their products may also mean that it is neccesary to use both process and discrete manufacturing.

Mixed Mode Solutions

Mixed Mode Manufacturing solutions are based upon tier 1 Enterprise Resource Planning (ERP) systems from Business & Decision's software partners, capable of providing industry leading functionality in all manufacturing modes and leveraging 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 recipes and/or bill of materials

• Warehouse management

• Managing batches and lots, including lot splitting and sub-lots

• Shop-floor integration (MES)

• Complete forward and backward traceability via common inventory

• Production equipment maintenance and validation

• Variable yield and potency

• Device history/batch record (DHF/DHR/EBRS)

• Co-products, by-products, rework and 'scrap'

• Electronic records and signatures (ERES/Part 11)

Such solutions are able to integrate complex manufacturing on a single site or across a global manufacturing organization, including the integration of contract manufacturing and outsourcing of sub-assembly, packaging, supply chain management and distribution.

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.

Implemented using industry best practice accelerators, all solutions comply with relevant Good Manufacturing Practice (GMP) regulations including 21CFR Parts 211, 820, 610 and 1271, EU GMP Regulations and standards such as ISO 13485. Solutions are validated as an integral part of Business & Decision's defined implementation life cycle.