Waters Laboratory Informatics has had great success working with customers using our systems in a regulated environment. This may be the reason why we deliver validation services to 90 percent of our regulated customers. It is our belief that the ideas discussed in this document can help you plan and execute the validation of your informatics system in a cost effective, timely manner, while minimizing the effort and impact on your organization.
From system design to the creation of change control tests to fit your specific environment, we can provide assistance with individual project tasks. Alternatively, if you decide to use Waters Laboratory Informatics service professionals to provide consulting services for the validation of your Informatics solution, you will notice we propose the validation strategy outlined in this document.
The aim of this document is to describe our simple strategy. The following will summarize the documentation strategy we recommend for successful Production use of our systems in regulated environments.