Process Manufacturing

Business & Decision specializes in implementing process manufacturing solutions within the Life Sciences industry based on solutions from leading software vendors.

Within the Life Sciences industry Process Manufacturing is primarily used by:

• Bulk (primary) pharmaceutical manufacturers

• Active Pharmaceutical Ingredient (API) manufacturers, including contract manufacturers

• Biotechnology organizations

• Medical device companies with batch processes e.g. those manufacturing reagents, polymers, pharmacotherapeutic products etc.

Process Manufacturing Solutions

Process manufacturing solutions from Business & Decision are based upon Enterprise Resource Planning (ERP) systems from Business & Decision's software partners and leverage best practice from other industries such as lean manufacturing and six-sigma. Enhanced by more than ten years of experience, process manufacturing solutions from Business & Decision incorporate the need for Life Sciences organizations to address complex manufacturing issues such as:

• Advanced planning and scheduling,

• Variable yield

• Formulation and blending

• Rework and 'scrap'

• Batch splitting and sub-lots

• Process plant integration (MES)

• Multiple units of measure

• Process plant maintenance and calibration

• By-products and co-products

• Electronic batch records (EBRS)

• Potency calculations

• Electronic records and signatures (ERES/Part 11)

With fully integrated financials systems and the ability to leverage additional ERP functionality such as purchasing, inventory management, quality management and document management, process manufacturing solutions from Business & Decision are also fully able to integrate complex supply chain requirements such as contract manufacturing, outsourced secondary manufacture (finishing) and packaging and third party distribution and logistics.

Implemented using industry best practice accelerators such as business flow accelerators specific to the Life Sciences sector, all process manufacturing solutions comply with relevant Good Manufacturing Practice (GMP) regulations. Solutions are appropriately validated as an integral part of Business & Decision's defined implementation life cycle, in accordance with GAMP® 5 Key Concepts.