Validation

Introduction
With the advent of programmable and computerised systems making their way quickly into the pharmaceutical industry, coupled with the growing requirements for all process-related equipment that has electronic password functionality to be validated, the need for validation procedures is on the increase. Yokogawa can produce validation procedures that can then be carried out by qualified engineers to assist in the smooth running of projects. Yokogawa’s DAQSTATION and DAQSIGNIN 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.

Product applications

Yokogawa’s range of DAQSTATION devices are supplied with independently written sets of documents covering installation and operational qualification. The company’s qualified engineers can provide a full range of onsite assistance – including installation, commissioning, set-up and the final validation procedures – to enable customers’ units to be ‘up and running’ in as short a time as possible. The DAQSTATION units are approved as 21CFR PART11 compliant in the application of electronic signatures and audit trail features.

Product Software
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.

Documentation support

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.

Systems validation

Yokogawa has been dealing with a number of pharmaceutical batch-process, control-systems, safetysystems 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.