Food and Drug Administration’s (FDA) 21 CFR Part 11 regulations on electronic records and electronic signatures. This is the latest in a series of white papers that Yokogawa and Xybion have drawn up on new CENTUM releases and a variety of other Yokogawa products and platforms, and it is being jointly released by the two companies on this date.
In the food and pharmaceutical industries, meticulous change control is required. The production control systems that are used in these industries must provide records identifying the personnel who carry out each operation, and when that operation was performed. To ensure that the U.S. pharmaceutical industry observes proper change control, the FDA issued the 21 CFR Part 11 regulations in 1997. This regulatory statute stipulated the requirements under which the use of electronic records and signatures could have the same standing as conventional paper records and handwritten signatures. Starting with CENTUM CS 3000 R3 and continuing on through to the latest version (R5.03) of CENTUM VP, Yokogawa has incorporated features and functions in its integrated production control systems that help users comply with these regulations.
Other regulations impose similar requirements. These include Annex 11 of the good manufacturing practice (GMP*1) regulations that were formulated by the European Union’s European Medicines Agency (EMA), and the Japan Ministry of Health, Labour and Welfare’s (MHLW) ER/ES guidelines on the use of electromagnetic records and electronic signatures in applications for the approval/licensing of medical products. This facilitation of compliance with the FDA’s 21 CFR Part 11 regulations allows Yokogawa to offer its production control systems for food and pharmaceutical applications in these other regions. This is expected to also foster compliance with the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S)*2. Yokogawa’s provision of tools that help users comply with 21 CFR Part 11 will accelerate the expansion of its industrial automation and control business in the growing medical market worldwide.
About CENTUM VP
The CENTUM VP integrated production control system is Yokogawa’s core plant monitoring and control solution for the oil, petrochemical, chemical, pulp and paper, pharmaceutical, food, and iron and steel industries. Yokogawa has been continuously developing and enhancing CENTUM VP as the cornerstone of its VigilantPlant® vision*3 for operational excellence. CENTUM VP, the latest generation of the CENTUM series of distributed control systems, was released to the market in 2008, and the latest version, R5.03, was released in June 2013.
*1 Management guidelines on the manufacturing of quality medical and pharmaceutical products. A number of countries have established their own GMP guideline/rules.
*2 An agreement between participating countries on the development, implementation, and maintenance of GMPs for the production of pharmaceutical products. Members include about 40 countries in Europe, the Americas, and Asia. Japan and a few other countries are currently applying for membership.
*3 Yokogawa’s automation vision for safe, reliable, and profitable plant operations. It aims to enable an ongoing state of operational excellence where plant personnel are watchful and attentive, well-informed, and ready to take actions to optimize plant and business performance. Based on this concept, Yokogawa introduces a variety of solutions through its Safety Excellence, Asset Excellence, Production Excellence, and Lifecycle Excellence initiatives.
In 2010, Xybion Corporation acquired the assets of Stelex ? The Validation Group, a corporation with almost three decades of experience providing compliance services to regulated industries, and formed the newly incorporated company Xybion Technology Solutions, a wholly owned subsidiary of Xybion Corporation. Xybion Corporation has companies located in the U.S., Canada, and India, and a satellite office in Europe. Xybion supports mission critical processes at companies operating in highly regulated industries in multiple countries. Xybion offers a comprehensive portfolio of interconnected solutions for quality, governance, risk management, compliance, preclinical R&D data management, enterprise asset management and Enterprise Content/Records Management for clients across multiple industry sectors.
Yokogawa's global network of 90 companies spans 55 countries. Founded in 1915, the US$4 billion company conducts cutting-edge research and innovation. Yokogawa (yokogawa.com) is engaged in the industrial automation and control (IA), test and measurement, and other businesses segments. The IA segment plays a vital role in a wide range of industries including oil, chemicals, natural gas, power, iron and steel, pulp and paper, pharmaceuticals, and food.