SOFTWARE VALIDATION

Accelerate the Deployment of Your New Instrument

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.