Validation services to meet growing demands

Edited by the Engineeringtalk editorial team Mar 30, 2005

The technical services department of Yokogawa UK has introduced a range of validation services to meet the growing demand for validation within the pharmaceutical and other process industries.

The technical services department of Yokogawa UK has introduced a 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 functions to be 21CFR PART11 compliant, the need for additional validation services is on the increase.

Yokogawa said it is meeting that 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 said that its qualified engineers can also provide a full range of on-site assistance - including installation, commissioning, set-up, final validation and SOP generation - to enable customers' units to be operational in as short a time as possible.

The Daqstation units are said to be 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 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 said Yokogawa, which can provide the production of validation documentation at an agreed fixed cost, helping to keep projects on budget.

Yokogawa said it 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 added that it significantly expanded its market share in the pharmaceutical industries from 1980 onwards and, following the introduction of the Centium 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, commented the company.

The company believes its 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.