One laboratory system that has been effectively designed to acquire data and control a variety of instruments is Waters Empower 3. Empower 3 is a chromatography data system (CDS) package that links to chromatographic instruments to help facilitate management of chromatography test results through data acquisition, processing, reporting and distribution. With Empower data acquisition and control features, scientists can:

• Define instrument control settings on connected chromatographic instruments using an instrument method.
• Use a single window and instructional dialog boxes to facilitate data acquisition and control over connected instruments.
• Observe a real-time chromatogram plots from 4 data channels as data is acquired.
• Control IEEE-488, Ethernet or serial interface-based systems, while being able to acquire up to four channels of data per system through the acquisition interface.
• Configure as many chromatographic systems as are necessary.

Given the benefits which this rich set of features for instrument control can bring to your laboratory, let’s discuss some best practice recommendations for integrating instruments with Empower 3.

Best Practices for Integrating Instruments with Empower

Check Instrument Compatibility. Check the instrument vendor’s website for system compatibility with Empower and the minimum requirements for interface (firmware, OS, etc.). Even if the system is not listed as compatible, it could still be possible to connect some instruments to Empower, such as detectors, using a module to translate analog signals to digital signals for data collection. Also, check the driver compatibility with the version of Empower the lab is currently using, as well as with the operating system version on all required LACE and Clients. To do this, you’ll want to determine which company is responsible for developing the driver, and also where to find the appropriate documentation for it. Note that different equipment vendors have different company agreements that control and determine who should provide support for the required driver.

Keep Instrument Control Software (ICS) Updated. Keeping all ICS in your Empower network environment updated in a timely fashion is important, as it allows for better control of system functionalities, reduces downtime caused by issues already known by system manufacturers, and helps to determine workarounds for issues not yet covered by the current ICS version. It can also reduce the upgrade effort when the time for major Empower upgrades are executed, as some of the ICS and firmware versions are backwards compatible. The more up to date your environment is, the less you have to cover when the time comes for CDS upgrades.

Be Aware of Potential Hardware Upgrades. In modern CDS environments, software and hardware are closely related, and in some instances upgrading software packages might generate impacts on your hardware, both in terms of support and costs. Having a thorough mapping of hardware configuration can help your company to avoid unforeseen costs and unnecessary downtime. Some examples are:

• Older systems with IEEE connection might require hardware upgrades to allow control over Ethernet. Since Waters discontinued the support to buslace cards, upgrading systems to Ethernet might involve replacing equipment logical boards and, in some instances, replacing entire modules like older chromatographic detectors.
• Systems that require analog-to-digital conversion might require the purchase of Waters e-Sat/in boxes in order to allow capture of detector signal.
• New ICS upgrades might remove the support to older instruments, which in some cases will require a replacement of the affected module or even the whole chromatographic system by a newer model.

Manage Upgrades Properly. In a consolidated Empower network environment, there will be potentially a large number of instruments and drivers. Driver updates create a significant burden on IT to deploy widely across all infrastructure (Clients and LACE’s) and require system downtime and coordination with end users. In order to minimize laboratory downtime and costs, a thorough study and mapping of each environment should be undertaken in order to gather the information necessary to determine which systems require an upgrade. ICS drivers also can require firmware updates on the instruments which impacts qualification status. This mapping will help to plan the driver pack upgrade for each LAC/E and, as a consequence, the firmware upgrade needs per system. Identifying instances were firmware upgrades are not needed can drastically reduce time consumed and costs on upgrade execution. This will not only cut time and effort spent on executing unnecessary upgrades, but also eliminate the need of a vendor specialist visit onsite to execute the firmware upgrades on the more complex modules and avoid the risk of possible firmware load issues.

Follow Proper Upgrade Protocols. Before upgrading ICS drivers, you should make sure that the reasons the motivated the update are indeed covered by the new version (this could be new equipment features enabled that are controlled via software, bug fixes, etc). An Impact Assessment should also be done to determine if the Known Issues (KIs) within the new version of the driver (if any) are acceptable. Additionally, validation test scripts should be created to document the issues that were corrected with the upgrade version, as well as to document that the equipment is functioning properly post upgrade. Note that, as long as a vendor audit is performed, it is acceptable to rely on vendor documentation to support the change of version with minimum testing on preserved functionalities of the system.

Consider Maintenance and Diagnostic Needs. When integrating third party instruments to Empower, make sure to study the tools available for system maintenance and diagnostics. As these tools vary based on the company agreement between Waters and the third-party companies, different models might apply to each scenario. Having a good understanding of the tools available for maintenance and diagnostics will help your company determine hardware and software requirements, required personnel training, and changes in SOP to cover the required needs.

Develop a Solid and Reliable Training Plan and Support Model. Integrating chromatographic systems from all the different vendors within the laboratory can impact how users perform their activities. Before changing the system that will control, process and report data from an instrument, it is important to ensure that users are trained accordingly on how to operate Empower to minimize any performance decrease in the laboratory. Having a good training strategy will also reduce the time it takes for new analysts to be prepared for laboratory operations, as they will no longer require training on multiple CDS.

At the same time, during a system failure, having all laboratory chromatographic equipment under one system could bring down multiple instruments and potentially impact the laboratory’s ability to complete analyses. It’s important to carefully determine the correct support model for the organization (8×5, 24×7, DBA, Site Support, Global Support, Instruments Roadmap…) to minimize the risks.

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. In order to maximize its potential to generate value for your organization, however, best practices described in this blog should be followed when integrating all instruments with Empower software.

Whether you have old instruments that were not integrated with Empower during your initial implementation, or new instruments that have come online since, automating your laboratory environment through effective instrument integration is best accomplished through a close partnership with a quality informatics consultant.

About Astrix

Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.  Through world class people, process, and technology, Astrix works with clients to fundamentally improve business & scientific outcomes and the quality of life everywhere. Founded by scientists to solve the unique challenges of the life science community, Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across
their organizations.

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Given that Waters Empower 3 typically generates large amounts of data, transcribing the data from Empower 3 to an external system can present huge risks from a data integrity perspective. As a result, scientific laboratories are looking for ways to maximize their results output from Empower and ideally utilize this system as their only solution for chromatographic results.

Empower is one of the most versatile and complete Chromatographic Data Systems (CDS) on the market and is able to handle multiple calculation requirements with extensive default functionalities. Often, however, additional customized calculations using “custom fields” are required to meet all the results requirements of modern scientific laboratories. In this blog, we will discuss best practices for implementing and validating Empower custom fields in order to minimize data integrity risk in your laboratory.

Implementing Custom Fields for Waters Empower 3 

Custom Fields are a combination of input fields and calculations that allow the user to input minimal data and receive an output of a calculated value utilizing Empower database field data. Before utilizing custom fields to generate your required results, however, first check whether the calculation requirements specified in a given test method or procedure could be accomplished by using default functionalities of the system (e.g., Amount, %Area, RT Ratio, etc…). If the default functionalities are not sufficient, then creating custom fields will be necessary.

The most common types of Custom Fields are “Text” or “Calculated”.

• Text Custom Fields are usually used to input values that Empower does not have the ability to natively receive (e.g., number of tablets, composite weight, label claim, recovery factors, etc…). It is important to create these fields together with a procedure/work instruction of how to use them and what to enter in each one of them so as to limit the user’s creativity and bring consistency to how the results are being generated between all the users in the Laboratory.
• Calculated Custom Fields are used to perform calculations when Empower default functionalities are not able to meet the test method/procedure requirements. These Custom Fields can automate the calculation process, remove the necessity of data transcription to an external system (such as an Excel spreadsheet), and reduce the review time required for a result release.

A few key best practices when working with Custom Fields follow:

Use Generic Names. When creating new custom fields, it is advisable to keep their names as generic as possible in order to allow them to be leveraged and reused in other applicable calculations. For example, naming a custom field “Percent_Content” allows you to reuse the field much easier and more often than if it was named “Percent_Ethanol”.

Set Up Appropriate User Privileges. To be able to create Custom Fields, you need to have the correct privileges in the System. Empower has 5 privileges specific for Custom Fields: Create, Alter, Delete, Lock and Unlock. You must also have the “Alter Any Project” privilege enabled in the user type to create a custom field.

Utilize All-In-One Reports. Custom fields also give you the ability to build All-In-One Reports that have all the information needed to properly assess a chromatographic analysis, while also being flexible enough to be used on runs from one to several samples. All-in-One Reports are easier to deal with, as multiple reports create higher volume of documents to review and increase the likelihood of reviewers missing something. In addition, having a locked All-in-One Report restricts user from modifying column headers, assures that the report is built for intended use, and reduces review cycle due to its standardized template.

Create a User Guide Document. When implementing Custom Fields, a user guide document should be created that contains all the information necessary for the Custom Fields to function as intended – how to set up sample sets, processing methods, etc. A User Guide is a necessity for the general user, as Custom Fields require standardized inputs in order to function properly.

Benefits of Implementing Custom Fields and All-in-One Reports

Implementing Custom Fields and All-In-One Reports allows more data to be treated and reviewed electronically, which will provide a number of important benefits for your organization:

• Quality Control– significant reduction in transcription errors, investigations and data integrity observations related to Empower.
• Saved Time – reduction in time spent on review cycle, report creation, user training, test method orientation, etc.
• Operational Efficiency – increases in the number of products tested and reported per analyst in Empower, along with number of tested products reviewed by reviewer in Empower.

Validating Custom Fields for Waters Empower 3 

Although Custom Fields functionality could have been tested during the Empower Operational Qualification, there is still a need to validate each Custom Field to provide evidence that the custom field being used is the correct one as per test method requirements. Some best practice recommendations follow:

Create an SOP. As part of the validation strategy, a SOP (Standard Operational Procedure) that describes the procedures to follow when developing, qualifying, implementing and maintaining Custom Fields within Empower should be created.

Create Good Documentation. As part of the validation, a protocol that references the User Guide should be created for the developed Custom Fields. In addition, manual calculation comparison documentation should be created to document the entire cycle of test method-based Custom Fields and report development, review and validation.

Leverage Previously Validated Fields. Validation of Custom Fields can leverage previously validated native fields and previously validated Custom Fields, allowing the implementation of those Custom Fields with minimum testing.

Follow Change Control Processes. When a Test Method that has associated Custom Fields is changed after validation, an impact assessment must be performed within a change control. If Custom Fields are impacted by a Test Method change, the Custom Fields need to be adjusted accordingly, with all adjustments following change control documentation and validation that is commensurate with the change.

Conclusion

Custom fields are a great tool to minimize any Data Integrity concerns that transcribing data into external systems poses, while at the same time providing huge gains in operational efficiency. By following the best practice recommendations described in this blog, the development and validation of Custom Fields can be done quickly, resulting in a process that is much less time-consuming, more accurate, less prone to errors, easily traceable and more user-friendly.

Astrix Technology Group has been helping scientific organizations implement and integrate laboratory informatics systems since 1995. The Astrix Team contains highly experienced and knowledgeable Waters Empower 3 experts that can help your organization implement innovative solutions that turn data into knowledge, increase organizational efficiency, improve quality and facilitate regulatory compliance.

The Astrix Difference:

• Over 3,500 implemented and tested Custom Fields
• We understand how to implement Custom Fields based on user needs (e.g., Result set only, Result set first, All or Nothing, Missing Peaks, etc.)
• We help our clients create a template document for standardizing user input on Sample Set, Processing Method, and Amount Tab
• We have implemented All-In-One Reports for many clients
• We can provide a complete validation package that has been utilized at many client implementations (Includes but not limited to: SOP, Protocol Template, Manual Calculation Documentation Template, and documentation to implement the User Input Standardization Document)

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