Master Data is the foundation upon which most information systems are built and operated. It is the static data that is stored in the system and serves as the standard for business-critical information. The static (or master) data is the backbone of the Laboratory Information Management System (LIMS) because it defines the Products, Analyses, Batches, Instrumentation, Users, and many other operationally essential data objects. Therefore, the processes surrounding Master Data implementation will usually dictate how well (or not) a system like LabWare LIMS is maintained over its operational lifetime. The master data sets the standard for the overall lab data management program.
It can be intimidating to work on master data, but, if it’s approached correctly, you can minimize the risk of missteps and maximize the functionality of your LabWare LIMS. Master data involves a number of tables, each with multiple and/or custom fields (and those fields each have a specific functionality in the system). It can be difficult to understand how to set up the system effectively if the LIMS Administrator and the users don’t understand exactly how the master data relates to the LabWare LIMS functionality.
All LIMS are especially sensitive to mismanagement of master data, due to the nature of the industries in which LIMS are deployed (health, pharma, food, etc.) To ensure that a LabWare LIMS Master Data Management (MDM) process will be efficient and robust, it is essential to invest in resources and processes that can streamline the MDM process.
In LabWare LIMS, the MDM process encompasses any modification to the static data. Although the main function of a LIMS is to capture dynamic data (test results), the static data defines the data. Throughout the operational lifetime of a LabWare LIMS, changes to the Master Data will occur frequently, and mismanagement can naturally occur, with often significant negative impacts on the system. Some examples of Master Data mismanagement are given in the following subsections.
Master Data in LabWare LIMS are stored in many tables, each with a specific operational functionality. Each table in turn contains several fields each, with a particular role and meaning within the table. Misunderstanding the (often complex) relationship between the tables, their fields, and the system functionality can result in issues, including:
Each of these issues requires different approaches to the desired modifications. Some modifications require changes not only to the master data but also to the accompanying dynamic data. If your organization lacks the expertise to make the required changes, a dedicated LabWare LIMS consultant can help you through the process.
Some master data tables in LabWare LIMS will require frequent modification and maintenance. In some cases, hundreds (or thousands) of records in tables may need to be updated at once due to an overarching change in the system (i.e., interface update).
In some cases, the LIMS administrator may need to update the system record-by-record in an extremely time-consuming and error-prone manual process. After the record updates, validation of the changes is required for regulatory reasons, which involves many levels of testing within the LIMS with virtual approval and e-signatures. Sometimes the testing is corroborated with individual (manually obtained) screen captures that would then be submitted for review. This approach to Master Data Management can put immense pressure on an organization’s resources and can be a bottleneck in project delivery pipelines.
Alternatively, a less time-consuming method from an implementation or LIMS administrator standpoint (but more time consuming from a validation standpoint) is to use LIMS Basic to make the changes outside the LIMS at the database level. This requires additional levels of documentation for the changes, guided by the organization’s quality assurance (QA) group.
Another approach to updating table records in LabWare LIMS is in the original definition of the new field—a default value that is automatically set by the database (Oracle or SQL Server), such that no other modification would be needed. This also would require conversations with your organization’s QA team to ensure the changes to existing records (not audited by the LIMS in this case) are compliant.
To ensure that your LabWare master data is managed properly across the software development life cycle (SDLC), there are certain steps you can take. Thorough documentation can be invaluable in this process. As it is for most IT solutions, documentation is very important for a LIMS. This is especially true in a highly modular and customizable system such as LabWare LIMS. Master data is the implementation domain which clients will frequently modify and customize. Custom tables and fields are used to capture information that cannot be captured in the standard build; therefore, customizations can lead to significant issues if the proper documentation is not produced.
Once you’re sure your LabWare master data is set up correctly, it will need to be maintained. System updates will require updating the master data to continue to serve the stakeholders according to the established process. When any customization is implemented, documentation should be revised to reflect the changes. The master data can be thought of as a living document that is constantly being updated to address regulatory changes (product specifications or analyses) or to add new products, substances, equipment, users, sites, and inventory. Most changes in the way a lab will operate will be reflected in a master data change.
There is a fine line between organizing master data in a way that is useful to the current needs of the system and anticipating future needs when changes inevitably occur. When those needs develop, there are specific tasks that should be done efficiently to save your lab from trouble in the future. Some of those tasks include the following.
When creating analyses in LabWare LIMS, some labs are overly specific in their naming conventions; so, when methods change over time (a common occurrence), the previously developed analyses become no longer useful. Naming conventions that are too specific leave no room for growth in the system.
If naming conventions are chosen carefully, it’s then possible to share master data for those analyses across multiple sites. This makes the addition of new sites or multiple instances of the LabWare LIMS much easier, which can simplify things greatly for your LIMS administrator.
The documentation that is typically done for master data (the user requirements specifications, functional specifications, and development specifications for regulated industries, or more generic requirements for nonregulated industries) can easily be transferred to test scripts or validation through in-system approvals. This not only can make the implementation of your LabWare LIMS less time-consuming, but also can support any required validation.
Nonstandard master data may also be required for specific situations. These can include the setup for storage locations, sampling points for environmental monitoring, translation information for other system integrations, etc. The same care should be taken to select naming conventions and provide documentation for the nonstandard master data as for the general LabWare master data. Doing so will ensure that the additional functionality supported by the nonstandard master data can also be accessed across multiple sites.
We hope that this blog post has demystified some of the intricacies of LabWare LIMS master data. If you feel that your organization may lack the bandwidth to invest in the necessary resources and processes to create or maintain your LabWare LIMS master data, a dedicated consultancy like CSols can help.
Are you confident that your LabWare master data is configured efficiently to support your organization’s growth?