The present emerging technologies have the potential to revolutionize the laboratory way of work, regarding the procedure’s digitalization and automation. In any procedure, the main objectives are to increase productivity, quality, and data integrity and decrease the duration of every step. Custom Fields (CF’s), a tool of the Waters Empower software, aims to obtain these objectives in the chromatographic analysis done in the laboratory.
Waters Empower is a chromatography data software that, when connected to chromatographic instruments, manages the data and the analysis results by means of data acquisition, processing, and reporting. The software can manage a large amount of data, complex calculations, and detailed reports, while, simultaneously, ensuring data integrity and conformity, by using tools such as electronic signatures and audit trails.
A great deal of data is generated, so transcribing it to an external system (such as Microsoft Excel), can be present huge risks from the data integrity point of view when processing occurs. For this reason, many laboratories are taking more and more advantage of all the functionalities that the Waters Empower software presents, and, ideally, use only this software for the data processing in chromatographic analysis. Custom Fields are one of those functionalities where the procedures are quicker, more precise, and less error-prone.
Custom Fields on Waters Empower
Custom Fields are personalized fields (user-defined fields) and consist of a combination of entry fields and calculations that allow the user to input the necessary values and, with the data generated by the software, obtain a result.
The more common Custom Fields are “Text” or “Calculated”:
- Text Custom Fields are based on text, such as the product name or the column name used in the equipment, or they can be numerical, like the lot number or label claim. These CF’s are usually used to insert in the software the names or values that are inherent to each laboratory analysis and, so, additional information can be documented;
- Calculated Custom Fields are used to perform calculations when the standard software functionalities are not capable to meet the test method requisites. These CF’s automatize the calculation procedure and eliminate the need to transcribe data to manual calculation methods, which reduces the reviewing time necessary, as only the entry values need to be verified.
There are some important rules recommended for those that work with CF’s, both for those developing and implementing it as well as the final user, such as:
- Generic names – when creating CF’s it is advisable to use clear and generical names, to allow them to be perceptible by the user and to be used in several projects/products;
- Generic calculations – CF’s are a great tool to select specific information and perform all the necessary calculations. The use of functions to generalize the used formulas is a good practice for those who developing CF’s;
- User guide document – when implementing CF’s, a user guide should be created with all the necessary information for the expected performance, such as how to complete the sample set or the processing method. The user guide is a necessity for the general user because many CF’s require standardized inputs for proper performance.
Applying these rules will allow a generalized CF’s use and facilitate the end-user understanding.
When all the CF’s are implemented and grouped with all the available information, the Empower software has the possibility to create reports with all the data generated, by the software itself and by the CF’s chosen, and it is possible to customize the data with the analysis type, sample sets, and calculations. Besides that, this implementation will allow the data to be processed and reviewed in an electronic way, which provides a set of advantages, like:
- Time – reduction of time used in data reviewing, report creation, user training, etc.;
- Quality Control – significative reduction of transcription errors, investigations, and data integrity related to Empower;
- Operational Efficiency – increase in the number of products analyzed and results reported for each analyst in Empower, as well as the number of analyses reviewed for reviewers.
Validating Custom Fields
Although CF’s may be tested during the Empower qualification, there is a need to validate each CF and ensure that is working correctly according to the test method. That are a few good practice recommendations, like:
- SOP (Standard Operational Procedure) – create a SOP that describes the procedures when developing, qualifying, and implementing CF’s;
- Good Documentation – as part of the validation process, the user requisites and the validation protocols can and must be created for the fields and reports developed;
- Previously Validated Fields – as previously stated regarding the development of generical CF’s, it is possible to use them, if previously validated, in several projects/products;
- Change Control Processes – when a test method, with associated CF’s, is altered after a validation, an impact evaluation must be performed in change control. If the CF’s are affected by the change, they need to be adjusted according to the change control documentation and validation.
Custom Fields are a great tool to minimize problems associated with data integrity that data transcription to external systems represents while providing higher operational efficiency.
Custom Fields implementation and personalized reports offer a series of important advantages, such as:
- Significant reduction in transcription errors, deviations, and investigations related to the Empower software;
- The fact that the data is present in one place only leads to higher integrity;
- Less time used in data analysis, review and reporting;
- Operational efficiency, allowing for more product testing and reviewing.
The development and validation of CF’s and personalized reports are a great way to render the analysis procedure in the laboratory quicker, more precise and less error-prone, more traceable, and friendly user.
Post written by Duarte, Life Sciences Consultant