March 18, 2020
Waters NuGenesis Lab Management System (LMS) is a powerful platform that combines synergistic data, workflow, and sample management capabilities to support the entire product lifecycle from discovery through manufacturing. Designed to fulfill the data management needs of laboratory scientists and managers, the foundation of the platform is the compliance-ready NuGenesis SDMS data repository, which allows scientific data generated in your laboratory to be accurately and automatically captured, indexed, and securely stored in a compliance-ready environment to meet any business requirements.
Due to the natural integration needs related to any SDMS, making sure that all business requirements are met and data integrity is kept along the entire data lifecycle is key to maximizing the return on investment (ROI) of your system. In this blog, we discuss the best practices associated with implementing and validating NuGenesis SDMS File Capture.
Implementing NuGenesis SDMS
When implementing NuGenesis SDMS, there are several best practice recommendations for the planning phase that will help to reduce time and effort while configuring the system.
Assess your laboratory data first. Performing an assessment of the data that will be captured by NuGenesis SDMS is recommended. Understanding the nature of the target data will help you determine:
- The average file size generated over a period of time. This will help determining the server(s) storage size needed for the future.
- The data types being generated. This will help determining what type of connectors will be used to bring data into NuGenesis SDMS, and the complexity of them.
- The network permission requirements. As NuGenesis SDMS can be implemented on a centralized location, knowing where data is located will help determining the level of configuration and access required to make data available for file capture from an off-site server.
With a good assessment of the data, you can create a well-defined strategy for your implementation that takes into consideration any potential effort that can be leveraged to reduce time, effort and costs. For example, by mapping all the applications within the laboratory that will require file capture, you might have the opportunity to discover that some data tags can be standardized across multiple file capture projects, making your final collected data more standardized.
Plan your architecture for the future. One common mistake that can occur on implementations involving any SDMS is not planning for the future. As laboratories grow over time, new systems get added to SDMS and the server space demand grows along with it. In the end, a storage server that required 15GB/year in the past can now require over 1TB/year.
This is especially important for new laboratories starting fresh on many applications along with SDMS. As there is no historical data to base a consumption evaluation and prediction, companies can overlook the impact a newer system can cause on space usage in NuGenesis SDMS. If no history of data generation is available, contact the target software vendor to get an approximate estimate of it.
Conducting an architectural assessment to plan for your future state is key not only to guarantee the continuous operation of NuGenesis SDMS, but also to help forecasting any resource improvements required for the future, such as additional storage space, extra user licenses, newer servers, to name a few.
Have well-defined permissions and roles.
Although the data captured by NuGenesis SDMS file capture templates can sometimes be captured only for archival purposes, with no batch release decisions being associated directly with these copies, the data is still important with regards to data integrity. The FDA’s ALCOA+ principles mention that data must be available throughout its entire life cycle. This also includes data archival, so having well documented definitions of what is being done and when is crucial to guarantee that archived data is safe and only accessed by authorized personnel. These documented definitions can include, but are not limited to:
- Design Specification
- SOPs (Administration, Operation, Maintenance, Disaster Recovery)
- Change Controls
Address all NuGenesis SDMS required network permissions before the installation. NuGenesis SDMS is heavily dependent on network access. To accomplish capturing data remotely on applications both on and off-premise, the system must have the required level of permissions to access these data silos and execute read/write operations. With that said, adjusting the system as you execute the system installation is not the best way to go, as some of NuGenesis SDMS requirements might conflict with other IT requirements (e.g., antivirus policies, ports availability, user account permissions), bringing your implementation to a halt.
NuGenesis SDMS uses a service account for the configuration of many of its modules, so having this account ready before the implementation is fundamental. Making sure you addressed all NuGenesis SDMS network requirements before starting the installation is vital to guarantee a smooth installation process, and also less intervention needed after the installation is completed.
Validating NuGenesis SDMS File Capture Templates
Once the previously discussed recommendations are complete and you have a functional NuGenesis SDMS implementation, it is time to test the file capture templates to make sure they are doing what they are supposed to do. Based on the principles from ALCOA+, you must guarantee that your data is complete, consistent and accurate throughout its entire lifecycle, and validating NuGenesis SDMS file capture templates is a best practice that guarantees it. A few recommendations to guarantee thorough testing and sound evidence that the NuGenesis SDMS file capture templates perform the way they are intended include:
Collect user requirement specifications (URS) for each individual file capture template. Each computerized system is unique, and so is the file capture template that must be associated to it. NuGenesis SDMS contains a series of connectors already created for some of the main lab applications, which gives you a lot of preconfigured information, but there might be other unattended requirements that must be met by configuring the file capture templates properly. By having the URS, you will be able to correctly identify what needs to be created and, by consequence, what you need to make sure was tested in your validation effort.
Have a well-documented configuration specification (CS). To have a clear and documented understanding of the overall needs for each file capture template, you must fully document the way these templates are configured to guarantee that user requirements were taken into consideration when the system was built.
Have a separate validation test script for each newly implemented file capture template. Once NuGenesis SDMS is fully implemented and the system validation is complete, there will still be new file capture projects and templates that need to be created. Having individual validation test scripts created for each new project is easier to execute and maintain than having to make changes at the much bigger validation package from the original system validation. Create a validation documentation that is modular enough to address the required specifications and tests in a much more streamlined way.
NuGenesis LMS has the potential to generate significant business value by improving laboratory productivity and efficiency. The best practice recommendations in this blog will help you realize this potential. For a successful implementation and validation of NuGenesis SDMS File Capture Templates you will need to:
- Plan ahead of implementation: decide what your data capture needs are, the required storage size, the permissions within the system, the required network permissions, etc.
- Document things thoroughly from ground up: collecting what the requirements are and the design of your file capture templates makes your life easier when designing tests for it, and also for future maintenance and diagnostics.
- Build your validation protocols in a modular design: testing file capture templates on smaller individual protocols is easier than testing all as one big deliverable. This allows for faster implementation when new file capture templates are required.
The Astrix Team has the product expertise, industry knowledge, and experience you need to ensure that you will get the most out of your NuGenesis LMS. Whether you are upgrading your NuGenesis system, looking to optimize your current NuGenesis implementation, or replacing your current system with NuGenesis LMS, our consistent yet customizable Astrix Approach™ will help you maximize the business value of your system. If you have any questions about Astrix Technology Group service offerings, or if you would like an initial consultation with an Astrix informatics expert to explore how to optimize your NuGenesis system, don’t hesitate to contact us