Empower 3 Implementation – The 4 Dos and Don’ts

A chromatography data system (CDS) is quite prevalent in life sciences laboratories today. The software enables multivendor controls of instruments that perform gas and liquid chromatography, mass spectrometry, and even ultra-performance liquid chromatography. If you are implementing a Waters Empower™ CDS for the first time or upgrading an existing system, there are many pre-implementation activities to think about and perform to increase success with an Empower implementation, deployment, and validation. We’ve gathered important Dos and Don’ts to keep in mind. We’ll start with the don’ts, so you know what to avoid; then we’ll share some things you can do that are part of our best practices as subject matter experts to ensure that your implementation succeeds.

The DON’Ts—Empower CDS

• Don’t think about Empower CDS locally in a global installation.

When implementing an Empower CDS globally, the setup of projects as well as the naming of data, sample sets, and processing methods must be globally harmonized. Custom fields and reports should not be specific to one location. It is not unusual that a company starts with one Empower site and then grows to a multisite implementation, where other sites may have their own ways of doing things. Creating different processes, conventions, and report structures at separate sites in the same system will make your Empower CDS installation more difficult to manage. Don’t succumb to this pressure—harmonize and standardize instead. If your organization supports it, consider adopting the FAIR data principles (Findable, Accessible, Interoperable, and Reproducible). 

• Don’t create one-off reports or custom fields for reporting official data in a global Empower CDS system unless they will be used frequently.

In a company’s global Empower CDS system, data reporting should look the same across all sites. In today’s enterprise business environment, laboratories send samples for analysis to other internal laboratories located around the world. This is especially true in method-transfer activities. When the chromatography results are reported back to the originating laboratory, they should use the same format as the Empower CDS reports from the originating laboratory.

Ultimately, data reporting should look and feel the same regardless of at which site/lab the data were generated. Data should be able to be viewed at all sites and by all appropriate users and administrators. All stakeholders should understand how the data and reports were generated.

• Don’t allow IT or the laboratory to administer the Empower CDS alone. It is a joint effort.

The Information Technology (IT) group and the Laboratory have different perspectives; the IT role is to confirm compliance with IT rules and security, while the laboratory role focuses on generating compliant data. When there is a disconnect between these groups, unforeseen challenges may appear. Working together and communicating effectively and proactively are critical for the successful implementation of a CDS. Engaging a neutral third party, like a consultant, may be necessary to bring everyone to a harmonized agreement. A consultant that is a Subject Matter Expert (SME) and aware of compliance best practices can be a useful intermediary to ensure that all perspectives are valued during the implementation.

• Don’t leave out any stakeholders in the design and validation of your Empower CDS.

Each stakeholder group brings unique and valuable contributions to the development of your Empower CDS. 

• IT focuses on data protection and patch installation procedures. 
• Laboratory management emphasizes business processes
• Scientists prioritize user interactions with the software and samples. 
• Reviewers are most concerned with the reporting of the data. 
• Analysts understand the sample submission process and sample processing. 
• The vendor is mindful of the installation process and software lifecycle.
• The quality group cares about data integrity and 21 CFR part 11 compliance in regulated industries. 

All views are important to a successful Empower CDS implementation, so be sure to obtain input and buy in from all stakeholder groups.  

The Dos—Empower CDS

• Do decide where Empower CDS calculations will live.

Many laboratory organizations also have a LIMS or ELN in addition to an Empower CDS. Even when the CDS is not integrated with a LIMS/ELN, the organization must decide where the chromatography-related calculations will be performed. Your proprietary calculations can live in either Empower or the LIMS/ELN, but should only be in one system for validation (if in a regulated environment), efficiency, and ease of use. The users will also need to know how to enter the samples in Empower by following procedures and training so the calculations can be properly performed. If it is unclear in which system calculations will be performed, there will be inefficiencies, duplication of effort, and confusion. 

• Do use Citrix, if possible, to host the Empower CDS.

Citrix, or another compatible remote desktop service, will drive down the IT support costs and will make deploying system changes easier. Additionally, in a regulated environment, using Citrix will reduce the validation effort because validation of the Empower CDS client will only occur once. All other clients (i.e., PCs) will access the Empower CDS through the validated Citrix client. Another benefit of using Citrix is that troubleshooting and fixing user issues is more straightforward because only a single client is used. Be aware, though, that user issues tend not to come up around Empower on a client PC but usually are attributed to Citrix issues, such as printing or launching the application.  

• Do emphasize Empower CDS training for analysts and administrators.

Training is critical when users and administrators are inexperienced with CDS products. These products use a database, which can make their use challenging for beginners. Empower CDS can perform many chromatographic calculations, and with proper training it can be a powerful tool. It is critical for Empower CDS beginners to go through training on data acquisition, Photo Diode Array processing, and reporting. Once comfortable with these aspects of the software, users will naturally explore more features. Your Empower CDS analysts will appreciate the availability of an expert for questions and answers along the way. Best practices provide for post-deployment, on-site expert support to respond to those user questions until the administrators are comfortable answering questions as they arise. 

• Do have a uniform naming convention for all Empower CDS entries.

Administrators should create and follow a procedure for the naming of projects, reports, and custom fields. Users should be trained to follow similar procedures for naming sample sets, processing methods, etc. This uniformity enables active project files to be more easily located in the system. A standard date and file ownership format for naming provides traceability, and identifies files for back up. The project naming convention, at a minimum, should include the project name and the year.

An example of a common naming convention for an Empower CDS Project is as follows:

Site: Boston, MA

Date project created: September 9, 2022

Samples all contain aspirin

Project Name: 2022/Boston_MA/Aspirin_3Q_2022

Note: the year the data is collected is at the root, with the site under that and the project in which the data are located under that.

An example of a naming convention for a Sample set in an Empower CDS project is as follows:

User: John Smith

Date Performed: September 9, 2022

Sample set name can be as follows:

JS_Sep_10_2022_SS

Note: proper date format must be used.

Let us help guide you into an implementation that will have your users, administrators, and other stakeholders excited about a CDS upgrade or new implementation rather than fearful and dreading.

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What other best practices have you realized for your Empower CDS that could be added to this list?