Being audit-ready starts long before inspection. It starts with using critical thinking to design analytical workflows that are scientifically justified, traceable, and defensible from day one.

Waters enables structured, lifecycle-oriented analytical design by combining advanced instrumentation, scalable chemistries, integrated informatics, and expert services into a connected solution. Aligned with ICH Q9(R1) and ICH Q14, this approach can help you apply quality risk management to analytical procedure development, enabling risk-based decisions and methods that deliver consistent performance across their lifecycle.​

• Risk-based, DoE-driven method design and development enabled by the ACQUITY Premier System and Arc Premier System with MaxPeak Premier Columns and industry-leading consumables​
• Inspection-ready genotoxic and trace impurity solutions enabled by Waters LC-MS systems and waters_connect for Quantitation Software, combining high sensitivity with traceable, controlled workflows​
• Simple and robust routine QC execution with the Alliance iS HPLC System, where intuitive operation and advanced functionality improve efficiency, enable end-to-end traceability, and reduce common errors​
• Confident chemistry selection across development and QC using scalable, consistent, high-quality Waters HPLC Columns for reproducible and reliable data​
• End-to-end traceability and audit trails with Empower Chromatography Data System (CDS), NuGenesis Lab Management System (LMS), and waters_connect Data Intelligence ​

You need to have confidence that your analytical processes will perform reliably — every run, every day. By embedding sound scientific principles and quality into workflows and methods from the start, and combining them with ongoing, vigilant monitoring, you can reduce variability, prevent errors, and maintain a sustained state of control with less rework.​

Waters helps your lab turn data into actionable insights, enabling consistent control and oversight as part of routine testing. Integrated workflows and informatics help teams monitor risks and method performance and identify emerging trends as you work to demonstrate a state of control and stay focused on delivering reliable results — not reacting to unexpected OOS events.​

Waters helps you stay in control by:​

• Embedding quality and scientific rigor in every method with a complete workflow incorporating the ACQUITY Premier and Arc Premier Systems and MaxPeak Premier Columns for unrivaled reproducibility​
• Enabling vigilant monitoring of systems, system suitability, method performance, data integrity, and trends with waters_connect System Monitoring, Empower Software, and waters_connect Data Intelligence for proactive oversight​
• Simplifying reliable, routine QC with the Alliance iS HPLC System and scalable columns, reducing variability and common operational errors, for more confidence in your data​
• Minimizing OOS results and investigations through early detection of process drift​

Building resilient operations means equipping your lab with modern instrumentation, connected data systems, and up-to-date workflows that keep processes running smoothly — even as regulations, technology, and business demands evolve. Waters solutions help you safeguard quality, maintain compliance, and ensure continuity across your operations.​

By combining advanced hardware, scalable chemistries, and connected analytical workflows, your organization can detect risks early, act proactively, and maintain inspection-ready processes — reducing downtime, minimizing disruptions, and sustaining operational resilience.​

Waters helps you build resilient operations by:

• Modernizing aging instrumentation through the Waters FlexUP Technology Replacement Program, enabling enhanced performance, increased uptime, simplified maintenance and predictable costs​
• Staying resilient to change by keeping lab software current with Empower Subscriptions and Waters Software Maintenance Plans and upgrades​
• Adapting rapidly to regulatory and operational change with standardized workflows, validation tools, the Waters Software Development Lifecycle Audit-Ready Kit, and Informatics Professional Services​
• Ensuring consistent method performance as requirements evolve with an extensive selection of scalable HPLC chemistries, modern LC technologies, and a versatile range of detectors, including the Waters Charged Aerosol Detector​

In regulated pharmaceutical laboratories, reliable systems, compliance-ready software, and responsive support are essential to sustain audit readiness and ensure resilient operations.

Whether you’re deploying new instruments, upgrading software, validating systems, or developing or migrating methods, Waters services are designed to optimize productivity, reduce downtime, and help you stay ahead of regulatory and operational demands.​

Waters supports you with:

• End-to-end instrument coverage, maintenance, repair, and qualification with FlexCHOICE: mySystem Service Coverage to help prevent downtime and optimize performance​
• Expert software deployment, data migration, and training for Empower Software, NuGenesis LMS, and waters_connect for Quantitation Software with Informatics Professional Services​
• Method transfer, scaling, validation, and application consulting with Analytical and Laboratory Services to ensure smooth transitions and consistent data quality​
• Professional compliance and validation support, including software qualification, documented best practices, the Waters Software Development Lifecycle Audit-Ready Kit, and regulatory alignment - to help you stay inspection-ready​