Whether you are upgrading or implementing Waters Empower™ 3 for the first time, there are several Dos and Don’ts that will yield a successful implementation, deployment, and validation. Additionally, there are many pre-implementation activities that companies should think about and perform to increase their rate of success.
The DON’Ts – Empower 3
1. In a global installation, do not think about Empower locally
When implementing Empower 3 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 multi-site implementation. When this occurs there is often a drive for more than one convention, process, or report structure. Don’t succumb to the pressure! Harmonize instead. Creating different processes, conventions, and structures in the same system will make your Empower 3 installation more difficult to manage.
2. Do not create one-off reports or custom fields for reporting official data in a global system unless they are used frequently
In a company’s global Empower 3 system, the reporting of data should look the same globally. In today’s enterprise business environment, laboratories send samples for analysis to other internal laboratories they are located around the world. This is especially true in method transfer activities. Once that data is reported back to the originating laboratory, the Empower 3 reports should look and feel the same as the reports from the originating laboratory.
Ultimately the reporting of data should look and feel the same regardless of which site/lab the data was generated. Data should be able to be viewed at all sites and by all appropriate users and administrators. All should understand how the data and reports were generated.
3. Do not allow IT or the laboratory to administer the system alone. It is a joint effort
The Information Technology group and the Laboratory have different perspectives. The IT role is to confirm compliance with IT rules and security. The laboratory role focuses on generating compliant data. Sometimes there can be a disconnect between the groups. The groups need to work together which can be a challenge. Sometimes engaging a neutral third party, like a consultant, to bring everyone to a harmonized agreement may be necessary. The consultant engaged needs to be a Subject Matter Expert (SME) that is aware of the best practices that are compliant.
4. Do not leave out any stakeholders in the design and validation of your Empower 3 CDS
Each stakeholder group brings a unique view and valuable contributions to creating your Empower 3 system. IT may be focused on data protection and patch installation procedures. The laboratory management may place an emphasis on business process. The scientists may place a high priority on user interactions with the software and samples. Reviewers may be most concerned with the reporting of the data. Analysts are in a position to best understand the sample submission process and the running of samples. The vendor may be mindful of the install and software lifecycle. The quality group may focus on data integrity and 21 CFR part 11 compliance in FDA regulated industries. All views are important. Obtaining input and buy in from all groups is critical to implementing a successful Empower 3 system.
The DOs – Empower 3
1. Decide where calculations will live
Many laboratory organizations, in addition to an Empower 3 Chromatography Data System (CDS), also have a LIMS. Even when the CDS is not integrated to the LIMS, the organization must decide where chromatography related calculations will be performed. Many of these calculations can live in Empower and /or the LIMS but should only be in one system for validation (if in a regulated environment), efficiency, and ease of use reasons. The users will also need to know how to enter the samples in Empower by following procedures and training so calculations can properly be performed. If it is unclear in which system calculations will be performed, there will be inefficiencies, duplication of effort and confusion.
2. Use Citrix if possible
Citrix will drive down the IT support costs and will make deploying system changes easier. Additionally, in a regulated environment, utilizing Citrix will reduce the validation effort since validation of the Empower 3 client need occur only once. All other clients (i.e. PCs) will access Empower 3 through the validated Citrix client. Another benefit of utilizing Citrix is that troubleshooting and fixing user issues is easier since only a single client is really being used. Interestingly, user issues tend not to come up around Empower on a client PC but usually are attributed to Citrix issues such as printing, launching the application, etc.
3. Place high emphasis on training analysts and administrators
When users and administrators have little or no experience with CDS products, training is critical. These products use a database which can make system usage challenging for beginners. Empower can perform many chromatographic calculations and with proper training can be quite powerful. In the deployment of Empower for beginners, it is critical to have the users go through training on data acquisition, Photo Diode Array (PDA), processing, and reporting. Once comfortable with these aspects of the software, the users will tend to explore more features. Empower analysts will need the availability of an expert for questions and answers along the way. Best practices dictate the provision of post deployment, on-site expert support to respond to questions. Users will feel supported and the laboratory will run more efficiently during this transition until the administrators are comfortable answering users’ questions.
4. Have a uniform naming convention for all entries.
Administrators should create and follow a procedure for the naming of projects, reports, and custom fields. Users should be trained to follow procedures for naming sample sets, processing methods, etc. This leads to uniformity and items will be more easily located in the system. It is recommended to follow a date and file ownership format in file naming for traceability, locating active project files, and identifying 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 3 Project is:
Site: Boston, MA
Date project created: October 10, 2014
Samples all contain aspirin
Project Name: 2014/Boston_MA/Aspirin_4Q_2014
Note: the year the data is collected is at the root with the site under that and the project the data is located in is under that
An example of a naming convention for a Sample set in an Empower 3 project is:
User: John Smith
Date Performed: October 10, 2014
Sample set name can be as follows:
Note: proper date format must be used.
Has your laboratory implemented an Empower 3 system locally and then deployed it to other sites and regions? If so, have issues around reports and naming conventions arisen? Has your Empower 3 system grown beyond the initial sites it was deployed at? Can these new sites be accommodated? Are analysts comfortable with Empower 3 or are they grumbling?