Launch of manufacturing solution to cost and compliance problems in pharmaceuticals.
The group, known as the Pharmaceutical Manufacturing Solutions Consortium (PMSC), comprises seven hardware and software companies: Beckman Instruments, Cincom Systems, Digital Equipment Company, Indusoft, Promis Systems and Groupe Schneider, with CGS (trading as Hoskyns in the UK) providing systems integration, consultancy and implementation services.
Hoskyns pharmaceutical executive Colin Wilson said: "Regulatory compliance is placing a huge and increasing cost burden on drug companies. If they are to remain profitable, they must try harder to reduce the cost of compliance and to improve manufacturing efficiency without compromising quality."
Alchemy 7 reduces the cost of regulatory compliance by fully automating the process of collecting and maintaining records for every batch of products at every step of the manufacturing process. A paperless system, Alchemy 7 eliminates the volume of paper records generated and substitutes automatic gathering of data which are then stored electronically.
Based on best-in-class, validated hardware and software components, Alchemy 7 is designed to satisfy the evolving requirements of regulatory authorities worldwide, including the UK Medicines Control Agency (MCA), the European Medicines Evaluation Agency (EMEA) and the US Food and Drug Administration (FDA). All components of Alchemy 7 have achieved validation in situ by the FDA in full-scale pharmaceutical production situations.
Alchemy 7 increases manufacturing efficiency by integrating the entire sequence of production operations and by integrating all levels of manufacturing control, from strategic resource planning down to control devices on individual machines. Dependence on manual operations is greatly reduced, leading to savings in time, cost and human error.
The consortium's solution also aims to improve the flow of information to managers and shopfloor personnel by providing instant access to real-time data from every application and all stages of the production process. A central feature of Alchemy 7 and its integration capabilities is Digital's Framework Based Environment (FBE) which provides a single interface for each software application, using object oriented technologies based on industry standards.
Two major benefits of the FBE approach to integration are flexibility and vendor independence. By providing a single interface for each application, FBE eliminates the need for multiple point-to-point data sharing between all pairs of applications, thereby simplifying the task of effective integration and allowing applications to be added, removed or modified with relative ease and speed. By segregating applications, FBE leaves users free to make their own choices of application, including legacy systems, thereby protecting and enhancing the value of existing investment.
FBE is designed for use across multi-vendor hardware platforms, networks and operating systems. As a result Alchemy 7 allows customers to continue using existing hardware and software while improving systems integration and information flows.
Quantified benefits for Alchemy 7, based on research by PMSC, include reductions in: batch record process costs (60 per cent); document production costs (50 per cent); document updating costs (60 per cent); inventory levels (20-30 per cent); scrap levels (30-40 per cent); quarantine levels (60-70 per cent); and cycle times (70-80 per cent).
Hardware and software components within Alchemy 7 include:
* Manufacturing business and control (MRPII) system from Cincom: controls manufacturing, maintains information about raw materials, inventory, production resources, bills of material and sales demands; specifies which products need to be manufactured and when.
* Document management and electronic batch record systems from Promis Systems Corporation. These are the central applications in paperless manufacturing; they monitor every stage of production electronically to produce a complete batch record.
* Supervisory control and data acquisition systems from Indusoft provide powerful connectivity to a host of factory automation products (from Groupe Schneider), so that the operator has a window to what is happening in the production environment. These systems integrate supervisory control and data acquisition with the paperless manufacturing process and provide management with quality information and control.
* To ensure compliance with good manufacturing practice requirements, Alchemy 7 includes the Beckman Instruments Laboratory Information Management System (LIMS) which enforces testing rules and provides audit trails as required by regulatory authorities.
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|Publication:||Industrial Management & Data Systems|
|Date:||Apr 1, 1995|
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