IT in Manufacturing

Validation goes digital

September 2020 IT in Manufacturing

Siemens and J&K; Technology have announced the development of the new CVal software solution for Comos. CVal is a digital process and plant validation software for use in the pharmaceutical industry, based on the Siemens Comos Plant Engineering software solution. This involves a wide range of different modules based on the Comos platform and the Comos Data Document Management System (DDMS).

Companies in the pharmaceutical industry have to ensure that their activities comply with regulatory requirements such as the Good Manufacturing Practice (GMP) – Annex 15: Qualification and Validation, constantly. Quality assurance guidelines had already been adapted in this field in 2015. The Siemens Comos software has been successfully used for engineering and life cycle processes in regulated industries for decades.

The new CVal software extension links data from the documentation system to the Comos engineering system. This creates a digital object-based life cycle management, which ensures both data integrity and traceability. CVal can easily be extended by other Comos software solution modules, to produce efficient life cycle management processes within an application.

The solution provides efficient data handling across a range of disciplines due to its central database and object-oriented approach. This offers the possibility to build digital twins. CVal is based on the digital twin of the plant available in Comos. The data for the various CVal modules can be generated directly on the relevant equipment or in existing libraries based on each object.

The Comos object orientation allows data to be linked within itself and with other plant equipment to provide the correct information where it is actually required. Errors, such as those produced by manual data entry or matching interfaces, can thus be prevented to the benefit of all the disciplines involved in a plant, such as engineering, operations and compliance.


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