Helping your lab deliver consistent quality and stay audit-ready

As regulatory expectations rapidly evolve, pharmaceutical organizations need smarter ways to ensure quality and control. Waters equips you to make proactive, risk-based decisions by providing the tools and support you need to achieve compliance, confidence, and resilience — from method design to continuous monitoring.​

​Waters helps your lab by:​

  • Enabling better, risk-based decisions through integrated systems, data, analytics, and regulatory intelligence​
  • Ensuring control with reproducible technologies, control-by-design software, and enhanced workflows that reduce out-of-specification (OOS) results and investigations​
  • Building continuous confidence by embedding audit readiness, data integrity, and traceability into routine workflows as part of quality risk management​
  • Supporting resilient operations with proven technologies that improve efficiency and safeguard supply continuity​
Read the White Paper
Mother giving glass of water and medicine to her ill child
Mother giving glass of water and medicine to her ill child

Why teams like yours choose Waters

Approximately 80%

of novel drug applications submitted to regulatory authorities (FDA*, EMA**, NMPA**) were from companies using Empower Software

of novel drug applications submitted to regulatory authorities (FDA*, EMA**, NMPA**) were from companies using Empower Software

*2023-2025 analysis by Waters
**2023-2024 analysis by Waters

"When the auditor got to our analytical lab, he asked, ‘What systems and software do you use?’ We said, ‘Waters and Empower [Software].’ He said, ‘Great, let’s go to the next lab.’ That’s the power — it just gives so much confidence."
— Jay P. Patel, Ph.D., Vice President of Analytical Sciences, Eagle Analytical Services

Always audit-ready

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.​

Read the White Paper
Scientist using Alliance iS in laboratory reaching for bottles on top

Always in control

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:​

Read the White Paper
Pharmacist speaking with patient about medication at pharmacy

Always resilient

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:

Read the White Paper
Child drinking water from glass

Always there for you

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:

Learn About FlexCHOICE Coverage​
Mother giving cough syrup to her little boy

Find out how Waters solutions can help you build control, compliance, and confidence in your lab.​

Back To Top Back To Top