In the recent past, scientific laboratories utilized multiple separate informatics systems, lots of paperwork and numerous standardized operating procedures (SOPs) to achieve data integrity and comply with all regulatory requirements and best practices. Improving sample throughput and data integrity in this scenario was challenging, however, as it relied heavily on user intervention, purchase of extra systems or even new hires to be able to handle the extra workload.

With massive increases in data volume over the last decade, and the growing concern from regulatory agencies around data integrity, integration between informatics systems has become a necessity, especially on systems that generate large amounts of data or that are crucial to the overall laboratory data workflow. Two examples of systems that fall into this category are LIMS (Laboratory Information Management System) and CDS (Chromatography Data System).

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. This system is utilized by organizations across many different sectors – pharmaceuticals, food and beverage, fine chemicals and clinical. 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.

Integrating LIMS with Empower 3 provides a number of important benefits for your laboratory:

• Data integrity is improved, since data transcription can be avoided by this integration.
• Higher lab throughput, as all calculations are executed automatically with minimal to no user intervention
• With the usage of electronic signatures on both Empower and LIMS, having a paperless lab becomes much easier.
• Data turnover can be improved by using tools (e.g., remote access or Empower Mobile) that enable users to review and approve data remotely.
• The integration between Empower and your LIMS allows information to be shared across sites globally and helps facilitate site harmonization (e.g., global methods instead of site-specific methods for the same testing, harmonization of processes between sites on where to perform calculations, etc).
• Standardized data workflows and processes make the overall system easier to maintain and support.
• Your lab staff can be reallocated to execute much more meaningful and profitable tasks, as less data transcription is required.
• Instrument OEE (Overall Equipment Effectiveness) can be improved as the overall data approval cycle can be reduced, effectively speeding up your ROI (Return On Investment)

Best Practices for Integrating LIMS with Empower

A few of the key best practices that need to be considered when integrating LIMS with Empower include:

Develop SOPs that guide your company on how to develop and maintain empower projects, templates and customized calculations.

When integrating Empower with LIMS, data can be transferred from Empower to LIMS through different routes depending on the chosen LIMS – direct data transfer, parsing of data from reports, etc. Whatever the integration solution is, changes to the Empower data organization must follow strict controls and thorough analysis to avoid any disruption to the integration between applications. For example, changes in a customized calculation naming convention or report method formatting might impact the LIMS system parsing script capability of capturing information from reports accurately. As such, having SOPs provides a roadmap to be taken each time new requirements or changes arise. These SOPs must include clearly defined responsibilities, comprehensive workflows and enough information to guarantee proper systems operation, maintenance and support throughout the entire systems lifecycle.

Make sure your data is secure throughout the integration process.

Some LIMS systems rely on the parsing of files such as “.csv” to capture data from external systems, and Empower can provide a multitude of exported files through its export method functionality. This can lead to a challenge, however, as these exported files have to be kept somewhere that the LIMS can sweep to identify candidates for parsing. This place can sometimes be a shared folder in the network, or even a local folder on a client computer (depending on LIMS requirements). As these systems generally require some level of read-write access, data security/integrity can become an issue if access privileges are not tightly controlled in order to prevent regular users from accidentally or purposely altering the data. In addition, it is important to develop testing scripts that deliver certainty that data integrity is maintained in all data transfer processes. Making sure that data is secure at every step of the integration between Empower and LIMS is key to assure regulatory agencies that your company has a strong quality culture and is focused on customer safety and product quality.

Build solid, reusable and consistent customized calculations in Empower.

Chromatography data calculations can be complicated and time consuming. They can include multiple formulas and data coming from external systems such as balances and Karl Fisher. In the past, companies relied on Empower in conjunction with external tools such as validated Excel spreadsheets in order to conduct advanced calculations, with the results then later on transcribed into other systems like LIMS or ERP to give continuity to data workflow.

Empower has a powerful tool for customized calculations called custom fields. It is a default functionality from Empower that can be used for a series of applications, such as:

• Create input fields that can receive information typed in by the user (i.e. sample label claimed amount)
• Create fields that will be used by LIMS to transfer data from LIMS to Empower (i.e. the sample id # in LIMS)
• Execute customized calculation based on one or multiple samples (i.e. blank area subtraction, content uniformity, total impurities calculation, etc.)

Having customized calculations developed in Empower is a good way of delivering readily available data to your LIMS, reducing the amount of work your company might have in developing calculations in a much more complex environment (e.g., LIMS). It also brings immediate benefits for the laboratory workload, considering that the final result is already available in Empower during data review process and no extra data treatment is required, making the overall process more time-efficient for the lab analyst. To achieve these benefits, it is imperative that SOPs are established for the proper development, testing, validation and maintenance of these customized calculations.

Figure out if the integration between Empower and the chosen LIMS needs to be bidirectional.

Although bidirectional communication might sound like the most logical way to integrate two applications, the benefits may not outweigh the extra complexity introduced for implementation, maintenance and especially support of this more complete integration. Careful consideration needs to be given to determine if bidirectional communication is the best option.

For example, a typical QC lab usually has a number of system suitability injections that can vary from test method to test method. This makes a scenario where the sample set could be transferred over from LIMS to Empower without any user input/adjustments (adding/removing injections, adding equilibrate/condition column lines, etc.) improbable. As a result, one directional communication from Empower to LIMS would likely be the most cost-effective solution.

In this case, Empower sample set templates could be created with most of the required information filled in, and with some additional custom fields to hold information required by the LIMS such as the LIMS sample ID. These sample ID’s could be added to this sample set manually or using barcode readers, and then after analysis is completed, data would be captured by LIMS through the one direction integration available.

The benefit in this one direction scenario is reducing system complexity and maintenance/support requirements. When the time comes for major upgrades to Empower (e.g., software versioning, Oracle upgrades, etc.), having a cleaner integration will allow you to execute these upgrades with less chances of finding unmapped incompatibilities in the process.

On the other hand, a clinical analysis laboratory with hundreds of samples per day throughput requirements and patient information confidentiality concerns might want to avoid manual user data inputs, so a bidirectional integration would be a good way to guarantee a good lab throughput without compromising on data integrity and patient safety. In addition, clinical analysis laboratories tend to keep technologies for longer periods with no upgrades due to the sensitive nature of their business, so any effort invested in developing a bidirectional integration might last longer in such environments.

Have a proper mapping of where the required data is located within Empower.

Empower data can be located in different tables depending on the data type, but not all data is readily available for extraction, depending on the tools used by your LIMS for data extraction. Some common examples are the summary calculations (i.e., average, sum, %RSD, etc.) that can be added to report method tables. These calculations are executed on the go once you open the report method for data review, but these values are not saved in the Empower database. So in order to extract these values to LIMS, there are two possible pathways your company might have:

• Use parsing tools to parse the Empower report method and extract the required values from it.
• Create customized calculations to execute those report calculations that are not saved in the Empower database, allowing it to be saved once data is processed.

In this example, it is evident that a proper mapping of data location is vital to determine not only the amount of customization required in Empower, but also if your LIMS has all the required tools to fulfill the integration requirements. If your company already owns Empower and is looking at purchasing a LIMS, having a proper knowledge of the available tools within Empower might help your company narrow down the LIMS options to the ones that will better accomplish integration requirements right out of the box.

Conclusion

Integrating different systems and applications within today’s laboratory environment is critical to establishing digital continuity across the product lifecycle, optimizing operational efficiency, enhancing innovation, establishing a foundation for future growth, and maintaining regulatory compliance. This is especially true for global organizations with dispersed laboratories.

As discussed in this blog, integrating Empower and a LIMS 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 integration for your organization. Astrix Technology Group has been helping scientific organizations implement and integrate laboratory informatics systems since 1995. The Astrix Team contains highly experienced and knowledgeable Empower and LIMS experts that can help your organization implement innovative solutions that turn data into knowledge, increase organizational efficiency, improve quality and facilitate regulatory compliance.