Quality Assurance

Business & Decision specialize in implementing quality assurance solutions within the Life Sciences manufacturing and supply chain domain.

Quality management solutions are usually implemented as part of:

• An integrated process manufacturing solution

• An integrated discrete or flow manufacturing solution

• An integrated mixed-mode manufacturing solution

• An integrated business process, with associated consulting services

Where appropriate, the need to balance good quality management principles is balanced against the desire for lean manufacturing (e.g. sampling and inspection) and in support of initiatives such as six sigma.

Our Quality Assurance Solutions

Business & Decision believe that Quality Assurance processes are an integral part of any manufacturing operation and not an optional 'bolt-on'. Solutions are based on software from one of Business & Decision's industry leading software partners, using configurable off-the-shelf (COTS) software and/or middleware as part of a Service Oriented Architecture (SOA) approach. Quality solutions from Business & Decision incorporate the need for Life Sciences organizations to address complex quality issues such as:

• Product Lifecycle Management (PLM)

• Inspection and testing

• Stability trials

• Electronic batch/device history records

• Workflow management

• Lot/batch traceability

• Adverse Events Reporting

• Audit management

• Complaints Management

• Corrective and Preventative Actions (CAPA)

• Document/content management

• Track and Trace

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