The life sciences industry is under immense pressure to maintain high drug quality and safety in a tough compliance environment while keeping investment and production costs low, and healthcare affordable. However, these challenges also present an opportunity for companies in the life sciences sector to streamline their processes and transform the way they manufacture to reduce investment risk, manage regulatory compliance, and enhance profitability.
COMOS, a Siemens software has helped companies such as Sanofi and Novartis to improve process development, plant engineering, asset management, operations maintenance and compliance management, and achieve impressive results. According to ARC Advisory Group, streamlined processes based on modular engineering and production technologies can help pharmaceutical companies reduce the time it takes them to move from drug development to full scale production.
Tutzing principles, Sanofi and COMOS
The Tutzing principles were defined in 2009 at the German Tutzing Symposium to ultimately reduce development, engineering, construction and commissioning time in the speciality chemicals and life sciences industries by 50 per cent. Based on methods such as modular production, reusable models and intensified processes, the Tutzing principles were inspired by Sanofi’s Dr Thomas Tauchnitz’s vision for integrated engineering published in 2005, where he specified the three basic principles for computer integrated production and engineering: every information is generated and maintained at only one location; existing knowledge is reused where possible; and the software tools stay interfaced while the production plant is in operation.
According to Dr Tauchnitz, using a single, consistent and up-to-date database for design, engineering, construction, handover, operations and maintenance can help increase productivity, shorten project time, accelerate operational readiness, and improve regulatory compliance. His vision for integrated engineering encompassed implementing standardised processes across the extended enterprise, reducing the number of systems and interfaces, organising centralised maintenance and support, and promoting company-wide knowledge management.
With an aim to implement his vision in greenfield projects at Sanofi in Germany, and aware that COMOS software mapped well to his approach, Dr Tauchnitz collaborated with Siemens to develop a bi-directional interface between COMOS and the PCS7 process automation system. A key outcome of the automation configuration and programming interface was a 20 per cent savings in engineering effort for Sanofi.
COMOS rollout at Novartis
Novartis’ goal was to make asset lifecycle information available to engineering, operations, and maintenance teams using a broad range of devices. The company’s implementation strategy involved the use of COMOS as the main application for technical information, in conjunction with SAP PM and CMX, an application for paperless calibration. To reduce their processes to only a few applications, Novartis migrated all electronic information, scanned all paper-based information to be stored electronically, and shut down all legacy applications.
Having standardised its network around the world, Novartis has ensured all of their facilities can collaborate without email attachments. Key outcomes also include simplified engineering workflows, reduced number of interfaces minimising manual data entry requirements, and a reduction in the number of applications in operation. The most important outcome was, however, an estimated reduction of 10 to 15 percent in the engineering effort.
Novartis is also working towards transitioning to paperless qualification documentation with key business goals being to reduce errors by eliminating manual entry and copying of information, global harmonisation and acceleration of workflows, and improved data management and information availability.
The COMOS software is designed to meet compliance requirements for US FDA 21 CFR 11 electronic signatures for paperless risk analysis. Siemens recently implemented additional functionality to assist with Novartis’ objectives including scope and compliance document templates for engineering, construction and operation; and document life cycle management with approval workflow and project controlling capabilities.
COMOS software functions as an asset data repository for process design, engineering, maintenance, plant operations and compliance management, equipping life sciences manufacturers with almost real-time visibility into plant health. By maintaining this single, consistent and global data hub, kept up-to-date at all times by all disciplines, drug manufacturers will gain from reduced engineering effort, shortened project times, better compliance, improved processes, and lower financial risk.
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