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, such as the Food and Drug Administration (FDA) or the European
Medicines Agency (EMA). Recommendations of independent institutions like the International
Society for Pharmaceutical Engineering (ISPE) support the operators of pharmaceutical plants
in important processes. 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 way. The loss of information due to duplicate data input or data transfer is
minimized. This information quality ensures consistent documentation and highly efficient plant
operation from the planning stage onward.