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.

Conclusion

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

The post Tips for Implementing and Validating NuGenesis SDMS File Capture Templates appeared first on Astrix.

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)

The post Tips on Implementing, Maintaining and Validating Empower 3 Software Custom Fields to Maximize Data Integrity appeared first on Astrix.