Pharmaceutical validation goes digital

27 August 2020

Siemens and J&K Technology, part of the J&K Group, have jointly developed the new CVal software solution for COMOS, Siemens plant engineering software solution.

JCVal is a digital process and plant validation software  solution for use in the pharmaceutical industry. It involves a 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 new CVal software extension links data from the documentation system to the COMOS engineering system. This creates a digital and object-based life cycle management which ensures both, data integrity and traceability. CVal can be easily extended by other COMOS software solution modules, to produce efficient life cycle management processes within an application.

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, eliminating errors produced by manual data entry or matching interfaces.

“The interaction of COMOS and CVal enables new possibilities for the regulated industry. For the first time, all the involved trades can work together in an integral software solution during the construction of a new plant or the change of existing plants,” said Rainer Krueger of J&K Technology.

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