Compliance Services

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:

• Risk Assessment
• Requirements Definition
• Installation and Configuration Scripts
• Test Plan Creation
• Traceability Analysis
• Process Development

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:

• Change control management
• Instrument Control Verification
• Data Acquisition Verification
• Fault Tolerance OQ
• Documented user training
• System use and maintenance SOP's
• Electronic data review process