We have provided GAMP Validation Support to the pharmaceutical industry since the early 1990’s where our first experience was in the retrospective validation of Turnbull Control Systems (TCS) programmable process controllers that had been programmed using the FORTH programming language.
Since then, we have been involved in the design and validation of automation systems for the pharmaceutical industry ensuring conformance to guidelines based on GAMP (Good Automation Manufacturing Practice) and have produced the documentation for all stages of the project life cycle. This experience includes equipment from the likes of Siemens, Rockwell Automation, Eurotherm and many others.
We have also supplied validation resource to our clients which has included performing 3rd-party code reviews and producing validation-related documents including Validation Plans, User Requirements Specifications, Functional Design Specifications, Hardware Design Specifications, Software Design Specifications, Test Specifications, Tractability Matrix and Validation Reports . We have also provided validation lead resource on projects and in doing so being responsible for ensuring the validated state of the automation system of an entire tablets production facility.
See the Control Specialists Services section of the Downloads page of this site for further information about our capabilities.
Call us on +44(0)1925 824003 or by email email@example.com