Empower-Based System Services
Maximize productivity and ensure compliance for systems on Empower Software
Qualification of your instrument’s software system can be resource-intensive and involve activities that, without the right expertise and technologies, could open you up to risk.
With Waters Compliance Services Team, you can streamline the qualification of Empower Chromatography Data System (CDS) on your chromatography instruments with the built-in Empower SystemsQT (Qualification Tool) to qualify and maintain your own instrument software system efficiently, enabling you to maximize productivity and improve readiness for audits. With support from Waters, you can accelerate the qualification of your chromatography systems, get total assurance that your system is performing and providing quality results as intended, and ensure data integrity and full traceability of your results in the event of an audit.
Leverage your in-house service or metrology team to perform automated system qualification using our self-directed Empower SystemsQT tool for ultra-performance liquid chromatography (UPLC)/ultra-high performance liquid chromatography (UHPLC), high-performance liquid chromatography (HPLC), and gas chromatography (GC) systems. With Empower SystemsQT, you can lower your compliance-related costs, optimize system productivity and in-house resources, and increase the robustness of your compliance activities.
Empower-Based System Services
Overview
- Reduce compliance risk and keep your lab operating efficiently with qualification support from Waters Compliance Experts
- Verify system software performance efficiently with built-in Empower SystemsQT, automating installation qualification (IQ) and operational qualification (OQ)
- Achieve a more accurate indication of overall system-level compliance and obtain secure, audit-ready qualification data anytime
- Eliminate most manual calculations, reducing the opportunity for human error and enabling faster, easier system-level tests
- Reduce time that systems are offline for qualification by about half and qualify multiple systems at once to reduce laboratory downtime
- Perform automated system qualification in-house using Empower Software with your in-house service or metrology team with self-directed Empower SystemsQT
- Comply with regulations, including 21 CFR 211.68 and 211.160 predicate rules, and get compliant-ready qualification data for 21 CFR Part 11, original data maintained on your CDS for 21 CFR 211.180, and complete data for review and approval for 21 CFR 211.194
Recommended Use: For qualifying and verifying your instrument Empower CDS performance at installation and throughout its lifecycle.
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Achieve a harmonized approach to qualification
Empower SystemsQT is built right into your Empower Chromatography Data System (CDS) and uses a patented process to qualify systems in the way they will be used. It can manage installation qualification (IQ), operational qualification (OQ), and system-level performance testing on Waters and third-party Empower Software-driven chromatography instruments.*
Reduce your risk and uphold data integrity
Rely on Waters Compliance Experts to help you navigate today’s complex regulatory requirements and ensure data integrity while helping you keep your systems and laboratory in 21 CFR Part 11 and 21 CFR Part 211.60, 211.68, 211.80(d), and 211.94(a) compliance. Simplify access to audit-ready qualification data that complies with all relevant regulations while eliminating the need for cumbersome external spreadsheets or third-party software. Enhance your productivity with audit trails and method change controls that easily track and trend your qualification results in a fully secure data environment. Reduce your risk of human error and increase the delivery of quality data throughout your system’s lifecycle.
Demonstrate that your Empower CDS is providing consistent results
According to United States Food and Drug Administration predicate rules for CGMP, Title 21 CFR 211.68, computer systems used to test regulated products need to be verified routinely to assure proper performance. Empower SystemsQT for software is designed to provide documented evidence that proper files have been installed, have not been altered nor corrupted, and demonstrates computational accuracy of the computer hardware with report generation. This testing is not designed to replace computer software validation specific to your intended use, but instead demonstrates the ability of Empower CDS to provide consistent results at installation and after continued use.
Leverage your in-house team with a self-directed approach
Perform automated system qualification in-house using Empower Software with Empower SystemsQT, which employs an automated, full-system testing approach for a more accurate indication of overall system-level compliance. This tool automated the qualification of UPLC/UHPLC, HPLC, and GC systems by testing them in the manner that they are used. Empower Software manages the data process – acquisition, processing, reporting, and archival – with minimal human intervention, minimizing potential traceability and transcription errors.
Although your Waters Field Service Engineer can conduct the qualification on your behalf, this tool is available as a self-directed option. Using self-directed Empower SystemsQT, your in-house service or metrology team can conduct and streamline the application of several Waters and Agilent systems.* With self-directed Empower SystemsQT, you can lower your compliance-related costs, optimize the productivity of your systems and in-house service resources, and lower the robustness of your compliance activities as Empower Software manages the entire data process.
*Qualifying systems include: Waters ACQUITY UPLC Systems, Waters PATROL UPLC Analyzer, Waters Alliance HPLC Systems, Waters Arc Systems, Waters ACQUITY UPC2 System, Waters e-SAT/In Module, Agilent 1260 HPLC systems and 1290 UHPLC systems, and Agilent 7890 GC systems.
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