Waters Empower 3 is a chromatography data system (CDS) that links to chromatographic instruments to help facilitate management of chromatography test results through data acquisition, processing, reporting and distribution. Empower 3 generates lots of data with complex calculations and detailed reports and has several tools that address compliance and data integrity concerns such as electronic signatures and audit trails.

Waters Empower 3 is continuously upgraded to meet the changing needs of laboratories across all industries – pharmaceutical QC/RD, food and beverage, oil and gas, petrochemical, water and environmental, manufacturing, contract labs, and more. Each new feature release of Empower 3 contains new functionality that is built upon feedback and customer input from these sectors and could thus bring significant benefits to the Laboratory user.

Potential benefits to upgrading your Empower software include:

• Implement known bug fixes to improve the system
• Bring validated system to current release
• Opportunity for new servers, new updated OS, redesigned architecture and High Availability (HA)/Disaster Recovery (DR) solutions
• Opportunity for a new Empower administration approach (i.e., naming conventions, project hierarchy)
• Implement newer and more reliable Instrument Driver Pack with new features to improve laboratory workflow and result output

In this blog, we will discuss tips for upgrading Empower that will help to ensure you maximize the business value for your organization.

Tips for Upgrading Empower

Do Strategic Planning. A strategic informatics roadmap is critical for helping your organization leverage IT investments to achieve maximum business value. An informatics roadmap is essentially a plan for the evolution of the architectural aspects of your laboratory informatics ecosystem over the next 3-5 years. The roadmap will help inform your decision as to whether or not upgrading Empower makes sense at this time.

Gather Information on the Existing Environment. Once the decision to upgrade has been made, you’ll want to gather all relevant information on the existing environment:

• Run verify files to generate the environment checksum
• Run Empower Inventory Viewer, or manually take a lab by lab inventory and document all the existing instruments in the laboratory. In a consolidated Empower network environment, there might be a number of instruments and drivers that will not be compatible with the new version of the system.
• Review the existing architecture (database size, technology in use, High Availability, etc…), and plan the hardware/software specifications considering the number of sites, users, instruments, type of data (Mass Spec vs 2D vs 3D channels) and latency between any remote sites and the Empower server(s).

Determine Whether You Want to Do an In-Place or In-Parallel Upgrade.

An In-Place upgrade is the scenario that allows in-place server, client and LAC/E upgrades using Empower automated installer and is typically done in smaller all Windows environment.

Pros:

• All system objects and all data are upgraded at once. There is no need to recreate nodes, systems, users, security grid, or convert data, etc…

Cons:

• Requires planning and downtime of entire environment – cannot run new samples until the process has been completed.
• Requires a good backup plan in the event the upgrade hits a road block part way through.
• Cannot be done in every scenario (i.e. Empower 2 to Empower 3) due to Oracle version incompatibility, Operating System incompatibility, Hardware requirements of the new version, etc…

An In-Parallel upgrade is the scenario where a completely new environment of Dev, QA and/or Prod is built while the older version is in use. This approach can be used with any size of installation, and is typically the “go to” approach for larger, multi-site WAN based installations. System Objects migration can be used to transfer all users, user types, nodes, message center and system audit trail to the new database.

Pros:

• Opportunity for new servers, new updated Operating System, redesigned architecture and High Availability (HA) and Disaster Recovery (DR) solutions.
• Can carefully plan the upgrade, conduct testing and execute the entire environment prior to cutover to production.
• Allows to move existing environment to the new at any granularity – from least to high impact sites, least to the greatest number of instruments connected to the system, etc…

Cons:

• Temporary consumption of IT resources (VM memory, network bandwidth, disk space, Citrix servers) during the period where both Empower installations coexist.
• Time for project completion is bigger compared to “In-Place” approach due to the multi-disciplinary nature of the implementation and interdependent activities that need to take place (i.e. system architecture design planning, system installation, system validation, training, etc.).

Create Good Project Documentation. For regulatory requirements, the system owners need to document all the relevant information about the system, and track changes to the system after the project ends. As part of the upgrade project, the following documentation should be created:

• Project Plan – Formalizes all the planning to execute, control and close the project. Assigns responsibilities, establishes a communication plan, creates a project timeline, etc.
• Validation Plan (VP) – The VP should provide an overview of the project, identify success metrics and define the acceptance criteria for the system’s release.
• User Requirements Specification (URS) – Defines what the user wants the system to do. Further verification of these requirements will be performed to ensure that the user requirements have been met through technical or procedural methods.
• System Design Specification (SDS) – Documents how the system is configured to ensure User Requirements are met. The SDS provides a detailed description of the user/system interfaces and the individual components of the Empower 3 System. This central record provides documentation of baseline configuration parameters for configuration management procedures.
• Risk Assessment – Created to determine the appropriate level of validation based on factors such as impact and possibility of error detection. The Risk Assessment determines the testing strategy used to verify each requirement and/or specification.
• Testing Documentation – IQ/OQ/PQ scripts or protocols for validation testing will be performed in a verifiable manner, to assure that the requirements, design and characteristics of the system and its components are as expected.
• Requirements Traceability Matrix (RTM) – The RTM provides a map to ensure verification of all User Requirements has been achieved. The RTM traces each specification contained in the URS document to a design component, operating procedure and test where verification of each requirement is established.
• Validation Summary Report – This report will be written to review the VP deliverables and to document the status of the entire validation process.

Develop a Solid and Reliable Training Plan. Before moving into the new version of the system, it is important that users are comfortable on how to operate Empower 3 in order to avoid any performance decrease in the laboratory. Having a good training strategy will reduce the time it takes for a new analyst to be prepared for the laboratory operations.

Create the Right Project Team.  Key members of the project team will include:

• Project Manager – Responsible for assistance with project planning, scope definitions, cost/resource monitoring and coordination, project timeline development, tracking project milestones and reporting throughout the project.
• Informatics Architect – Assesses existing architecture and provides input on the design of the system architecture (Bandwidth, solution for High Availability, Hardware/Software Specifications).
• Informatics Engineer – Responsible for installation of the system on the network infrastructure, developing custom fields and reports, data integrity assessments, system configuration and data migrations.
• Validation Specialist- Develops Computer System Validation deliverables for regulated environment – Validation Plan, User Requirement Specification, Design Specification, IQ, OQ, PQ, Traceability Matrix and Validation Report.

Conclusion

Empower 3 software enables your organization to effectively manage data generated by all your chromatography instrumentation, plus run different detection techniques and applications, method development and validation, integrated chemical structures, and polymer analysis. As discussed in this blog, upgrading Empower is a great way to improve your overall laboratory informatics ecosystem, but there are a number of best practice recommendations that are important to follow in order to maximize the benefits of the upgrade for your organization.

Astrix has been helping scientific organizations implement and integrate laboratory informatics systems since 1995. The Astrix Team contains highly experienced and knowledgeable Empower experts that can help your organization implement innovative solutions that turn data into knowledge, increase organizational efficiency, improve quality and facilitate regulatory compliance.