Waters can help accelerate the deployment of your new instrument software systems with the confidence it will meet regulatory expectations and demonstrate that your Workstation, Workgroup or Enterprise solution is fit for its intended use.
Our services are based on the current International Society of Pharmaceutical Engineering (ISPE) Good Automated Manufacturing Practice (GAMP®) 5 methodology, the United States Food and Drug Administration (USFDA) Code of Federal Regulations (CFR) Title 21 Part 11, and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) computerized system guidance to manage the overall risks associated with implementing analytical systems.
Waters can assist you with all phases of your validation planning:
Maintaining control of a computerized laboratory system is an on-going activity. A comprehensive system validation approach must include consideration for protecting and maintaining the system's validated state throughout its operational lifecycle. In order to maintain regulatory compliance for your computer systems, all Waters software can be deployed with routine Installation Qualification (IQ) and Operational Qualification (OQ) services utilizing the same tools used during our internal testing, and leveraging the automated tests we develop for our product release.
Waters has been providing comprehensive consulting services surrounding the validation process to our customers since 1999. An experienced Waters Validation Consultant will help you develop a practical, risk-based solution for your data systems.
Waters Compliance Services offered for routine, on-going use of Waters Data Systems include: