- At a glance
At a glance
|In the pharmaceutical industry, a product’s time-to-market has to be extremely short, the production highly efficient, and the product quality impeccable. In the engineering and operation of a plant, it is crucial to comply with the stipulations of national and international regulatory authorities. If a plant’s qualification and the validation of the product quality are integrated into the plant’s early planning stage as well as in its later operation, all parties involved will have access to all relevant information and compliance with all stipulations will be ensured. This shortens a product’s time-to-market and allows the plant owner to more effectively take advantage of the patent protection term.
With COMOS, Siemens delivers a comprehensive software solution for the optimal integration of engineering and operation. Using a global, single data platform, the up-to-date engineering information is always available over the entire lifecycle of the plant. This information, as well as the individual steps taken in planning and operation, are documented in a complete and structured. This quality ensures consistent documentation and highly efficient plant operation from the planning stage onward.
Development and production of pharmaceutical products requires the consistent planning and documentation of all processes over the entire plant lifecycle. There is high pressure to reduce costs because patent protection terms are short, and the cost for product development is increasing. The highly efficient use of time during the patent protection term is supported by COMOS with integration of plant implementation and operation. The development information from the clinical testing phases is also integrated with scale-up activities.
Ongoing market consolidation results in larger companies. This leads to increasingly complex production facilities. In order to run facilities in a profitable way and in accordance with Good Manufacturing Practice (GMP), the integration of plant engineering, operation, and maintenance becomes ever more important to drug manufacturers. These factors have to be included in every development process from the very beginning in order to produce drugs efficiently. COMOS enables standardization globally as well as at the plant level. This increases the reusability of information that has already been generated. New plants can be constructed based on existing data and information. This means that new locations can be established flexibly and cost-efficiently all over the world.
COMOS enables for the pharmaceutical industry:
- Integrated compliance management across all stages of engineering and operation
- Consistent flow of information with a common database
- Logical connections and automated processes facilitate efficient process and electrical engineering
Easier document management by using the Responsibility Matrix for assignment of responsibilities
- Automated generation of templates based on Document Execution Plan
- Efficient plant supervision with automatically generated maintenance schedules
The software solution COMOS PQM (Project Quality Management) has been extended to fit the special demands of the pharmaceutical industry. The result is a solution that meets the distinctive requirements of this field of business. The required documentation structure is generated on the basis of standardized templates as early as in the design and engineering stage. The timely delivery of documents to the responsible party is facilitated by the assignment of responsibilities based on a Responsibility Matrix. These processes are in accordance with the GMP and therefore compliant with the stipulations of the regulatory authorities.
COMOS PQM for the pharmaceutical industry enables the qualification of the entire plant during all stages of engineering and operation. The consistency of blueprint and plant as well as material and supplier specifications can all easily be checked with COMOS. The test results of the operational qualification can be documented, archived,and retrieved easily as well. The software creates all documents required and makes the latest version available at all times. This means that all steps toward approval can be taken properly and efficiently. In order to validate the products of a plant, all assets influencing the quality of the finished product have to be identified.
COMOS accesses the information from the development and test stages. Risk assessment within the system enables fast corrective and preventative intervention in the process. Changes in the actual state of the plant are integrated into the database and synchronized with the digital plant. This avoids discrepancies between them. It can be checked easily if a new validation or qualification becomes necessary through changes in the plant and the necessary steps can be initiated.
COMOS makes it possible to easily transfer documents generated during earlier projects to a new one. This shortens the time-to-market and optimizes utilization of the patent protection term, which makes COMOS an integral part of any change management processes.
The extension of COMOS PQM for the pharmaceutical industry provides integration of all process-relevant systems, thus enabling direct project monitoring. Additionally, the software solution is a foundation for standardization and bundling of competencies. COMOS PQM also supports continuous innovation across the lifecycle of the plant. This increases the efficiency of the entire production processes, enabling faster time-to-market and minimizing risks and costs, thereby improving the overall competitive position. Consistent process validation based on international standards can be ensured at all times.
Access to the latest plant status is available with COMOS, enabling the seamless interaction between the plant operator and the engineering, procurement, and construction (EPC) supplier. This seamless interaction ensures that all demands and requirements can be addressed and tracked from the earliest project stages. COMOS can provide consistent and up-to-date information to applicable oversight agencies.