Case Study: Biotechnology Company Retools its Manufacturing and Quality mission critical systems
Abstract
This global biotechnology company sought to retool its manufacturing and quality systems into an integrated strategic solution which, coupled with re-engineered business processes, aligned the manufacturing computing environment with corporate growth goals and objectives. AAI’s assistance in developing, validating, and implementing a new suite of systems helped change their corporate computing culture while simultaneously reducing cycle time in the manufacturing of product, improving overall efficiency in managing documentation and increasing control which reduced waste and cost.
The Challenge
With over 9,000 employees and revenues of more than $9 billion, this discoverer, developer, manufacturer, and commercializer of bio-therapeutics relies heavily on information technology.
The company’s existing manufacturing systems were not sufficient to keep pace with the demands of this growing company. Manual processes glued transitions from manufacturing to quality and back again which contributed to increased cycle times. There was little to no integration between their existing systems which made it difficult craft necessary cross functional reports. One of AAI’s principle consultants led the integration, validation and implementation of the new suite of applications which consisted of ERP, MES, EDMS and LIMS packages.
How We Helped
The AAI principle consultant led a cross-functional team that developed a Technology Architecture using industry best practices for high availability and failover. State-of-the-art technology was leveraged for secure wireless transmissions across the manufacturing facility and industrial PC’s were purposed for the appropriate environmental conditions within the manufacturing areas. A comprehensive validation plan was crafted to ensure that all hardware qualification and software validation activities aligned towards the agreed upon strategic objective. Delicate vendor management issues were expertly addressed and all systems were integrated as required.
To help reduce costs while increasing efficiencies and value, a pc-client imaging facility was crafted to ensure that all validated software is successfully distributed to over one thousand PC’s. Automated test scripts were used to test response time performance under varying data and user loads.
Lessons Learned
The implementation of an integrated suite of manufacturing systems led to significant improvement in manufacturing cycle times and efficiency in the management of controlled documents. Its universal acceptance was facilitated by a collaborative team style guided by the principle consultant knowledge of quality, manufacturing and information technology business processes. The company has leveraged these mission critical systems to support unprecedented growth.