Validation goes digital - Siemens and J&K Technology announce partnership

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• Siemens and J&K Technology support digital validation process
  
• New CVal software solution for digital process and plant validation in COMOS for the pharmaceutical industry
• Efficient data handling across all disciplines - using a central database and object orientation

Siemens and J&K Technology, part of the J&K Group, announce the development of the new CVal software solution for COMOS. J&K Technology, a specialist in cGxP Compliance Services, has developed the CVal solution. 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). As a result, this digital application consistently creates greater data integrity, quality, coherence, and topicality.

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 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 software solution provides efficient data handling across a range of disciplines due to its central database and object-oriented approach. This and offers the possibility to build a so-called “digital twin”. 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. CVal extends COMOS by the following modules: Specification management, traceability management, risk management, change management, test management, document phase management, deviation management, and project management.

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.

“With CVal, we have added a significant component to our product portfolio based on our #siemens COMOS plant engineering software solution. This allows us to help our customers in the pharmaceutical industry produce digital, auditable plant documentation,” says Philipp Fisler, #siemens Industry Software GmbH.

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