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HIGHLIGHTS OF EMPOWER PLUS ELN:■■ Empower Enterprise with

NuGenesis ELN in a single- server implementation

■■ Convert and enhance existing laboratory spreadsheets and documents into ELN forms with built-in SmartBuilder capabilities

■■ Mitigate the compliance risk of traditional uncontrolled spreadsheets and documents

■■ Enhanced compliance features such as:

■— Authorized access control

■— Automated version control

■— Document-level and cell-by-cell audit trails

■■ Centralize and secure laboratory spreadsheets and documents for use in a regulated environment

SINGLE SERVER IMPLEMENTATION TO ENHANCE YOUR LABORATORY WORKFLOWLaboratories today are replacing paper forms or lab notebooks with electronic documents like spreadsheets and word templates. This presents a compliance risk due to the lack of audit trails and access controls needed to meet regulatory requirements. Empower™ PLUS ELN combines Empower Enterprise with NuGenesis™ Electronic Lab Notebook (ELN) capabilities in a single server.

MINIMIZE THE COMPLIANCE RISKEmpower PLUS ELN is designed as a simple solution for Empower users to eliminate compliance risks on traditional spreadsheets and word documents by converting them into compliance-ready NuGenesis ELN forms. These forms provide full audit trails and other technical controls needed to meet 21 CFR Part 11, as well as other requirements for electronic records and signatures, providing the required document control of laboratory records in a regulated environment.

ACCESS CONTROL ONLY TO AUTHORIZED USERSGeneral office applications do not provide the tools to ensure that only authorized users in your organization can access these critical, controlled spreadsheets. It is also onerous for lab managers to ensure that users are consistently working with the most current and approved version of the spreadsheet template. With Empower PLUS ELN, you can simultaneously manage authorized user logins and access to their ELN forms. Automated version control ensures that the users are accessing only the most current approved copy of the ELN spreadsheet template.

CENTRALIZED STORAGE AND MANAGEMENT OF LABORATORY DOCUMENTSTraditional management of laboratory spreadsheets as individual files presents challenges for location, backup, routing for document review, and electronic signatures. Empower PLUS ELN provides centralized storage and management of laboratory documents. The database allows all records to be searched, enabling easy location of documents for review, and includes configurable electronic signature capabilities

AUDIT TRAILSThe full audit trail function of Empower PLUS ELN tracks all data entered by users into to the controlled ELN forms. When spreadsheet documents are used in Smart Procedures, even cell-by-cell changes in data can be tracked.

Empower PLUS Electronic Lab Notebook

Compliance-ready CDS solution with consolidated platform for all laboratory spreadsheets and documents

[ PRODUCT SOLUTION ]

Waters Corporation 34 Maple Street Milford, MA 01757 U.S.A. T: 1 508 478 2000 F: 1 508 872 1990 www.waters.com

EASILY CONVERT YOUR EXISTING SPREADSHEET AND DOCUMENTSConverting existing validated laboratory spreadsheets and documents into NuGenesis Smart Procedures is as easy as drag, drop, and lock. This allows laboratories who are currently relying on electronic documents, and have an inventory of validated document templates, to leverage the efforts they have already made. This makes it easy for users to transition from the traditional, uncontrolled documents they use today.

MAINTAINING THE VALIDATION OF EXISTING SPREADSHEETS AND DOCUMENTS WITHIN EMPOWER PLUS ELNEmpower PLUS ELN maintains all converted documents in their validated state, so that minimal re-validation of the spreadsheet is required. Existing documents can be made smarter with the built-in tools provided by Empower PLUS ELN with appropriate additional validation.

Waters, The Science of What’s Possible, NuGenesis, and Empower are trademarks of Waters Corporation. All other trademarks are the property of their respective owners.

©2019 Waters Corporation. Produced in the U.S.A. October 2019 720006547EN LM-PDF

WATERS GLOBAL SERVICES

Delivering world renowned services and supportWaters Service and Support offerings are tailored to optimize your laboratory productivity while addressing your budget realities. Our offerings help maintain system peak performance, minimize down time, address scientific application challenges, and support stringent compliance requirements. As your services and support provider, we are committed to the success of your laboratory and business.

Waters quality support and consultative services ensure your success wherever your laboratory is located in the world.

Waters has consecutively earned the ACE Award since 2001 for providing best-in-class technical knowledge, issue resolution, and process support.

Figure 1. Cell-by-cell audit trail viewer in spreadsheet documents.

Figure 1. Cell-by-cell audit trail viewer in spreadsheet documents.