Empower™CDS

Software Solutions for MALS​
Empower™ Chromatography Data System (CDS) supports robust collection, processing, and reporting of CQAs from the DAWN™ multi-angle light scattering (MALS) and Optilab™ differential refractive index (RI) instrument lines.​

 

Accelerate high‑quality data generation for proteins, peptides, and other biomolecules with streamlined Empower Software MALS and RI workflows that integrate seamlessly into your existing operations—all within a compliance‑ready, scalable system that delivers optimized, traceable, and reliable data flow.​

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Features​

With more than 30 years of proven performance in regulated laboratories worldwide, Empower CDS is trusted to manage data across all types of environments. From single workstations to complex, multi-site global enterprise deployments, Empower Software provides flexible options to scale with your operations.​

Designed for today’s quality risk management requirements, Empower Software provides straightforward tools to strengthen data security, ensure traceability, and maintain audit‑ready workflows to enable adherence to compliance with GxP, 21 CFR Part 11, Annex 11, ISO 17025, and other global standards.​

  • Increase Efficiency: Automate calculations and streamline the complete analytical workflow from acquisition to batch review within a single, unified platform​.​
  • Reduce Risk: Audit trails enable traceable workflows, and automated technical controls minimize manual steps and errors for consistent, reliable data handling across instruments and sites.
  • Accelerate Collaboration: Shared methods, centralized data management, controlled user access, and consistent workflows ensure that everyone is working from the same high‑quality data for rapid decision-making.​
Your data. Streamlined, compliant, and ready for decision-making—with Empower Software.
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How it works​

Streamlined Workflows. Unmatched Productivity​

Empower CDS with integrated MALS acquisition and analysis simplifies complex workflows for both seasoned professionals and new users in regulated environments. Whether you are an expert seeking advanced functionality or a beginner looking for ease of use, Empower Software delivers streamlined performance that keeps your lab operating efficiently and with confidence.

Quality Without Compromise​

Strengthen data integrity and minimize risk with advanced SEC‑MALS workflows built directly into Empower CDS for traceable, confident data management in your quality‑critical environments. Assess, control, mitigate risks, and monitor risks throughout the analytical lifecycle within a single, integrated platform supported by automated workflows and technical controls that minimize manual steps, human error, and bias. Leverage Waters experts and the Waters Software Lifecycle Development Audit-Ready Kit to streamline risk-based validation and help your lab stay current and compliant.​

Scaled to Your Operations​

Harness the full power of your light scattering and chromatographic data with flexible Empower Software Subscriptions and deployments that scale from a single workstation to an enterprise-wide system—on-premises or in the cloud. Unlock streamlined workflows with centralized data management, automation, and compliance across your network for long-term data integrity.​

Harmonize With One Software​

Delivering robust and reliable chromatographic performance, Empower CDS seamlessly integrates with the Waters suite of innovative liquid chromatography systems in addition to other third-party LC, GC, IC, and CE instrumentation. Implementing Empower CDS controlled LC systems with the Waters world-class DAWN MALS instrument line and advanced detectors enables precise multi-angle light scattering analysis for absolute molecular characterization.

Resources

+ Application Notes & Ebooks​

+ Infographics​

+ Technical Resources

Webinars

Using Empower Software for SEC-MALS Analysis

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From Aggregation to Impurity Profiling: Analytical Best Practices for GLP-1RAs

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Introducing Empower Software for SEC-MALS: Enhanced Compliance Suite for Development and QC

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Hidden Threats: High-Throughput Strategies to Detect Aggregates in Biotherapeutics

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CQA Assessment of GLP-1 Agonist with SEC-MALS

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DAWN™ MALS

miniDAWN™ MALS

Optilab dRI

FAQs

Q: Is MALS required for protein release under ICH guidelines?

A: Technically, ICH Q6B allows for "validated alternative methods," but it specifically demands characterization of physicochemical properties. If your protein is prone to aggregation or has a non-globular shape, traditional SEC-UV can lead to false negatives—missing small amounts of harmful aggregates. MALS is the gold standard to prove your product is a monomer and remains stable throughout its shelf life, often becoming a required part of the BLA/NDA package to avoid regulatory pushback.

Q: Can MALS reduce false positives in molecular weight determination or stability testing?

A: Yes. Unlike relative SEC-UV, which relies on retention time, SEC-MALS measures light scattering from first principles. This avoids false positives caused by non-ideal column interactions and false negatives where complex polymers, such as branched species, do not match standard calibration curves.

Q: What Critical Quality Attributes (CQAs) does MALS provide?

A: SEC-MALS provides data that concentration-only detectors cannot reach. In an Empower-MALS environment, these CQAs are calculated and reported automatically:

  • Absolute Molecular Weight: Not an estimate based on standards, but the true mass.
  • Aggregate Profiling (HMWS): Quantifies dimers, trimers, and higher-order aggregates.

Q: How does the Empower and MALS integration support compliance?

  • Unified, audit-ready data management with optional enterprise deployment.
  • Reduced validation burden by consolidating two software systems into one.
  • Enhanced traceability and electronic record-keeping.
  • Simplified regulatory submissions through standardized, widely recognized reporting frameworks.
Your data. Streamlined, compliant, and ready for decision-making—with Empower Software.
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