Control System Validation
TVC is committed to the delivery of quality validated products and systems to all our customers that require strict assurance that all products and systems will consistently work correctly when brought on-line. In many cases in the chemical, pharmaceutical and biotech industries users require strict assurance that all products and systems supplied by suppliers will consistently work within the operational and performance guidelines used to select the equipment and/or system. To deliver quality-validated systems, it is essential that a structured and documented methodology be followed throughout the development and the life of a product and/or system.
With the progress of technology, the number of automation systems used in all types of manufacturing has been increasing and the quality management of automation system development is essential. This is particularly true in industries that are regulated by the Food and Drug Administration and especially the pharmaceutical industry. One means of establishing a quality management system for companies involved in automation system development is to provide guidance for quality assurance that is aligned with the regulatory requirements of the FDA.
The process of development and maintenance of automation systems is different from that of most other types of industrial products. In such a rapidly evolving technology field it is therefore necessary to provide additional guidance for quality systems where automation systems are involved, taking into account the present status of this technology.
In order to support validated project TVC has defined our own Validation Project Development Methodology (VPM). The VPM defines a consistent approach to the specification, design, implementation, testing, installation and maintenance of automation systems. It is a methodology that is designed to be compliant with the requirements of the FDA and follows cGMPs. It is intended for use by TVC Systems to deliver custom solutions in a project-based environment.