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

CVal is a digital process and plant validation software for use in the pharmaceutical industry, based on the Siemens COMOS Plant Engineering software solution.

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.
Siemens Digital Industries (DI) is an innovation leader in automation and digitalization. Closely collaborating with partners and customers, DI drives the digital transformation in the process and discrete industries. With its Digital Enterprise portfolio, DI provides companies of all sizes with an end-to-end set of products, solutions and services to integrate and digitalize the entire value chain. Optimized for the specific needs of each industry, DI’s unique portfolio supports customers to achieve greater productivity and flexibility. DI is constantly adding innovations to its portfolio to integrate cutting-edge future technologies. Siemens Digital Industries has its global headquarters in Nuremberg, Germany, and has around 76,000 employees internationally.
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Siemens AG (Berlin and Munich) is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 170 years. The company is active around the globe, focusing on the areas of intelligent infrastructure for buildings and distributed energy systems, and automation and digitalization in the process and manufacturing industries. Through the separately managed companies Siemens Energy, the global energy business of Siemens, and Siemens Mobility, a leading supplier of smart mobility solutions for rail and road transport, Siemens is shaping the energy systems of today and tomorrow as well as the world market for passenger and freight services. Due to its majority stakes in the publicly listed companies Siemens Healthineers AG and Siemens Gamesa Renewable Energy (as part of Siemens Energy), Siemens is also a world-leading supplier of medical technology and digital healthcare services as well as environmentally friendly solutions for onshore and offshore wind power generation. In fiscal 2019, which ended on September 30, 2019, Siemens generated revenue of €86.8 billion and net income of €5.6 billion. At the end of September 2019, the company had around 385,000 employees worldwide. Further information is available on the Internet
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J&K Technology is part of the J&K Group and, together with J&K Consulting, forms the basis for balanced and goal-oriented consulting in the regulated industry. J&K Technology specializes in digital lifecycle management of systems and processes. With CVal, J&K Technology provides a software solution that bundles the GMP know-how of the J&K Group from the past 25 years and combines innovative processes in the area of compliance with established processes from the areas of engineering and operations. Further information is available on the Internet at
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Evelyne Kadel

Siemens AG

Klaus-Bungert-Str. 6
40468 Duesseldorf

+49 (173) 5649708

Rainer Krüger

J&K Technology GmbH

Kirchstrasse 11
41569 Rommerskirchen

+49 (160) 8934020