Wednesday, November 01, 2006

Wide range of validation services offered

With the expansion of programmable and computerised systems in the pharmaceutical industry the need for additional validation services is on the increase.

The Technical Services Department of Yokogawa UK has introduced a comprehensive range of validation services to meet the growing demand for validation within the pharmaceutical and other process industries. With the expansion of programmable and computerised systems in the pharmaceutical industry, coupled with the growing requirements for all process-related equipment that has electronic password functionality to be 21CFR PART11 compliant, the need for additional validation services is on the increase. Yokogawa is meeting this requirement by offering validation services implemented by qualified engineers to assist in the smooth running of projects.

Yokogawa's DAQSTATION and DAQSIGNIN data-acquisition and recording products already have full validation documentation, and the relevant procedures can be implemented by qualified Yokogawa engineers or in conjunction with the customer, depending on the site policy.

DAQSTATION devices are supplied with independently written sets of documents covering installation and operational qualification.

The company's qualified engineers can also provide a full range of onsite assistance - including installation, commissioning, set-up, final validation and SOP generation - to enable customers' units to be 'up and running' in as short a time as possible.

The DAQSTATION units are technically compliant to the requirements of 21CFR PART11 with electronic signatures and audit trail features.

The DAQSIGNIN software that is used to view the data acquired on the DAQSTATION units also has an independently written installation and operational qualification (IQ/OQ) procedure.

The IQ/OQ process can be carried out by Yokogawa's qualified engineering team or as assistance during the validation procedure.

The production of validation documentation can involve huge amounts of time and thus incur high unforeseen costs that can rapidly deplete project funding.

Yokogawa Technical Services can provide the production of validation documentation at an agreed fixed cost, helping to keep projects on budget.

Yokogawa has been dealing with a number of pharmaceutical batch-process, control-systems, safety-systems and continuous process customers since the introduction of the company's first distributed control system in 1975.

Yokogawa significantly expanded its market share in the pharmaceutical industries from 1980 onwards, and, following the introduction of the CENTUM CS3000 Series of control systems, now has an installed base in the pharmaceutical sector of around 300 systems in bulk materials plants and more than 230 systems in medicine forming plants around the world.

This combination of technical expertise and abundant customer experience means that Yokogawa is uniquely suited - and willing - to offer full support for flexible process operations according to GAMP and cGMP directives.

The company can also make a significant contribution to the reduction of total cost of ownership (TCO), as well as providing solutions with scaleable, integrated and open systems architectures.

* About Yokogawa Electric Corporation - Yokogawa's global network of 18 manufacturing facilities, 82 affiliate companies, and over 650 sales and engineering offices spans 28 countries.

Since its founding in 1915, the US$4 billion company has been engaged in cutting-edge research and innovation, securing more than 7,000 patents and registrations, including the world's first digital sensors for flow and pressure measurement.

Industrial automation and control, test and measurement, information systems and industry support are the core businesses of Yokogawa.

* About Yokogawa Europe - the European headquarters were founded in Amersfoort, the Netherlands in 1982.

Throughout Europe Yokogawa has its own sales, service and engineering operations.

This dedicated network has been extended to Central and East Europe and Southern Africa to further enhance the coverage and support associated with serving the process control and automation market place.

We develop and produce flowmeters at Rota Yokogawa in Germany, liquid analysers and industrial safety systems in the Netherlands.

In addition to this dedicated network of Yokogawa subsidiaries a select organisation of Test and Measurement (T and M) subsidiaries and distributors is established in certain areas to support the specific customer needs of this continuously developing and specific market of T and M instrumentation.

* About Yokogawa UK - Yokogawa UK, part of the global Yokogawa Corporation, is a supplier of enterprise technology solutions to the process, manufacturing and utility sectors.

The company is a technology and market leader in instrumentation and control, and holds many key patents and national and international approvals.

Yokogawa UK's headquarters are in Runcorn, Cheshire, with additional system sales support operations in Milton Keynes.