Future-proof qualification throughout all engineering and operating phases

In close cooperation with well-known pharmaceutical companies, the Siemens Industry Automation Division has further developed its Comos object-oriented, plant management software solution specifically to meet the requirements of the pharmaceutical industry. The software supports all the processes required for integrated information management in pharmaceutical plants.

The industry-specific expansion of Comos PQM (Project Quality Management) is now used to qualify pharmaceutical plants throughout all engineering and operating phases. This ensures conformity with the stipulations of national and international regulatory authorities, simplifies compliance with documentation requirements and shortens project times.

Joachim Eilers, Pharmaceutical Sales Manager, Comos Plant Engineering Software, Siemens, said, “Qualification can start at the project initiation phase. The basis for verifying the qualification of a plant is to have complete and up-to-date documentation throughout all project phases and plant sections.” Comos ensures that all information is recorded and processed consistently, right from the start of plant engineering. For example, during the design and engineering phase, the necessary document structure is automatically generated on the basis of standardized templates. Comos PQM makes it possible to clearly assign responsibilities and schedules. This way documents can be processed promptly by the people responsible and forwarded to the appropriate authorities. These workflows conform with both GMP (Good Manufacturing Practice) and the stipulations of the regulatory authorities.

Comos supports the user with a large number of functions and check mechanisms. For example, the quality-related relevance of plant sections and systems can be determined by means of a risk assessment. The documents required for qualification are automatically assigned to the relevant system and collected in a quality documentation package together with engineering documents and test results for functional qualification. This package always contains the current documentation relating to the actual state of the plant, because all changes to this are recorded in the Comos database. Any plant modifications which require renewed qualification can be easily determined with the integrated risk assessment tool, and the necessary steps initiated.

A solution developed in the project can be saved in Comos as a model and used again in subsequent projects. This standardization results in higher quality and efficiency in project management and, in turn, shorter project run times, thus accelerating market entry and improving patent utilization.

The Siemens Industry Sector (Erlangen, Germany) is the worldwide leading supplier of environmentally friendly production, transportation, building and lighting technologies. With end-to-end automation technology and industrial software, solid vertical-market expertise, and technology-based services, the Sector enhances its customers' productivity, efficiency, and flexibility. With a global workforce of more than 100,000 employees, the Industry Sector comprises the Divisions Industry Automation, Drive Technologies and Customer Services as well as the Business Unit Metals Technologies. For more information, visit http://www.siemens.com/industry

The Siemens Industry Automation Division (Nuremberg, Germany) supports the entire value chain of its industrial customers – from product design to production and services – with an unmatched combination of automation technology, industrial control technology, and industrial software. With its software solutions, the Division can shorten the time-to-market of new products by up to 50 percent. Industry Automation comprises five Business Units: Industrial Automation Systems, Control Components and Systems Engineering, Sensors and Communications, Siemens PLM Software, and Water Technologies. For more information, visit http://www.siemens.com/industryautomation

Reference Number: IIA2012033004e

Contact
Ms. Evelyne Kadel
Industry Automation Division
Siemens AG
Klaus-Bungert-Str. 6
40468 Düsseldorf
Germany
Tel: +49 (211) 6916 1003
evelyne.kadel@siemens.com