Why have one standard for CDS interfacing?
The first question to consider regarding establishing a standard for CDS to LIMS interfacing is "Why?" In an environment where one laboratory may use a variety of CDS solutions or in a wider context where an enterprise may employ multiple CDS solutions and multiple LIMS, what benefits are gained by finding a single solution for interfacing? The simple answer is that, for companies that utilize more than one CDS within their organization, maintenance of multiple interfacing solutions creates unnecessary overhead, pulling the laboratory away from its core business. The better solution is a single interface that can address all of the laboratory's requirements.
An interface that can work with a variety of LIMS or CDS will not need to be replaced if either application is updated or replaced. In regulated industries, having one solution for all CDS/LIMS interfacing reduces validation requirements. Personnel training can be reduced if one solution can be applied to all CDS to LIMS interfaces. Training can be further reduced if that same solution can be applied to all instruments throughout the lab.
Establishing one interfacing solution will reduce:
•system maintenance requirements.
Challenges facing a CDS to LIMS interfacing standard
Interface to all major CDS and LIMS
In order to standardize on one CDS/LIMS interfacing solution the application cannot be limited to working with a specific CDS and/or LIMS application. The interface must be able to be configured to work with any LIMS or CDS. The key word is "configurable." Applying the solution to different applications should not require a major programming or implementation effort. Solutions that don't readily adapt to changes in the LIMS or CDS impose unnecessary restraints on future planning in the laboratory. Future choices regarding new applications or upgrades to existing applications can be limited by the constraints of the interface.
|A configurable template simplifies setting up a CDS/LIMS interface|
Interfacing between a LIMS and a CDS is not a case of simply taking CDS data and placing it in the LIMS. To be truly effective, a CDS/LIMS interface needs to be able to provide bi-directional communication between both components. A bi-directional interface must be able to actively extract information from, as well as submit information to, each application. This can involve querying the LIMS for a worklist of samples that are scheduled to run, uploading that list as a sequence file to the CDS and then collecting the results from the CDS and reporting to the LIMS. To be considered as an interfacing standard, the CDS/LIMS interface must be capable of fully automating all of the steps involved in worklist management and data reporting.
Manage a variety of data formats
Being able to interface to a variety of CDS and LIMS applications requires that the interfacing solution be able to manage a variety of data formats. The number of available programs, file formats and interfacing requirements necessitates a configurable solution that can directly manage everything from text files to ODBC queries, in almost any format.
Different CDS applications will manage both data upload and data reporting differently. Specific fields will vary from one application to another, as well as the means for transferring data and sample information. Ideally, a standard CDS/LIMS interface will provide a means of minimizing the impact when setting up the CDS portion of the interface. The best solutions will provide a configurable template for each CDS that can be configured to meet specific implementation requirements.
In many CDS applications, it is required that information from other sources and data from other analyses be combined with data from the CDS before it is reported to the LIMS. An example would be a sample weight that is incorporated into the CDS calculations. The weight may be part of the sample information that is contained in the LIMS or it may come from weighing the sample prior to the analysis. A good CDS interface will be able to incorporate that type of additional data as part of the information transfer between the LIMS and the CDS.
Each LIMS has its own interfacing requirements and each installation of the LIMS may include its own modifications that are unique to that specific facility. The reporting component in a standard CDS/LIMS interface must be flexible enough to accommodate the unique features of each LIMS implementation. As LIMS interfacing requirements change, it should be possible to easily modify the reporting component of the interface without impacting the other aspects of the interface.
Provide additional data management capabilities
As sophisticated as today's CDS applications are, it is often necessary to perform additional calculations and reformatting of the CDS data before reporting it to the LIMS. In many cases a spreadsheet application, such as Microsoft Excel, has been used to provide additional processing capabilities. While a spreadsheet can perform these functions, it is not the most efficient way to manage the data and it certainly does not provide the level of data security that meets with regulatory compliance requirements. A standard CDS/LIMS interface should have the flexibility to meet any additional data management and calculation requirements within a controlled and secure environment.Additional calculations that the CDS/LIMS interface may perform before transferring data to the LIMS include:
•averaging of results from duplicates
•spike and RPD calculations
•unit conversions i.e. ?g/L to mg/L
•compound name conversions
•check limits to determine out-of-range results before reporting to LIMS
•add a comment or flag to a result before reporting to LIMS.
The interface should also have the flexibility to carry out the calculations and data review transparently, with the data being automatically reported to the LIMS, or the analyst may be given an opportunity to review and approve the results before committing them to LIMS. In either case, the interface should provide the level of automation required by the laboratory and ensure the security and integrity of the data throughout the process.
Meet regulatory compliance requirements
In selecting a standard for CDS to LIMS interfacing it is imperative that the solution fully meets the regulatory requirements of the laboratory in which it is to be deployed. Even for laboratories not operating within a regulated industry, ensuring the accuracy and integrity of CDS data is a mandatory function for any CDS/LIMS interface. There must be confidence that results are reported exactly as they are produced by the analysis.
21 CFR Part 11 and CROMERRR, from the FDA and EPA respectively, are two examples of Good Practices being incorporated into regulatory rulings governing electronic records. To meet these regulatory compliance requirements, all activity must take place within a secure environment. Electronic signatures, password protection, audit trail and fileless data transfer are all components that the CDS/LIMS interface should incorporate to achieve the required level of security.
Electronic signatures should be able to challenge the user to revalidate their identity before selected operations are carried out or after a specified period of time. All challenges and their responses, successful or not, should be automatically recorded in an audit trail.
Password protection should be a multi-level component that controls user access to menus, setups, editing and calculations. To meet with regulatory requirements and to minimize the overhead for administration, password protection should ideally incorporate features such as password aging, history checking, a minimum password length, user lockouts, multiple logon denial and even e-mail notification of security violations.
An audit trail should record, to an independent database, all significant actions within the CDS/LIMS interface. Any changes should be documented, along with when the change was made, who made the change, and a comment explaining why the change was made.
An integral component in 21 CFR Part 11 compliance is protecting the integrity of data files. An interface that can interact directly with both the LIMS and the CDS, without creating additional intermediary files, simplifies the process of ensuring regulatory compliance.
Selecting a standard CDS/LIMS interface
In any laboratory where chromatography is a core analysis, efficient management of the CDS data can be a critical component in improving overall lab efficiency and productivity. Timely reporting of results with minimal manual intervention frees up analysts' time and ensures the integrity of the data that is being reported.
We have seen that using one standard solution to interface CDS with LIMS reduces the overhead required for implementation, training, validation and support of the interface. If that solution can also be extended to other instruments and instrument data systems in the lab, the benefits of a single interfacing solution are further multiplied.
In deciding on a standard for CDS/LIMS interfacing it is important that the solution meet the following requirements:
•interface between any CDS and any LIMS
•provide full bi-directional communication between the CDS and LIMS
•perform additional calculations and reformatting of data
•provide direct, fileless communication between CDS and LIMS
•meet regulatory compliance requirements.
There are some different options to choose from when considering a CDS/LIMS interface. Many of them are application-specific, limited to working with a certain LIMS or CDS. Finding a single standard solution that can interface between any CDS and any LIMS not only simplifies the immediate interfacing process, it also provides the flexibility to adapt to future changes in the laboratory environment.
Mike DeWitte is Account Manager and Steve Bolton is Marketing Manager at Labtronics Inc. They may be contacted at firstname.lastname@example.org.