Laboratory automation is one of the big topics that can be tackled to enable new and improved processes. However, we tend to see this automation mostly as the introduction of robotics.
The aim of laboratory automation is to increase productivity, raise data quality and reduce process cycle times. But what if it could be introduced on a smaller, yet still effective, scale in any laboratory, specifically for chromatographic analyses? Did I pique your interest? Great, then let me introduce you to the wonderful world of custom fields in Waters Empower 3!
First, let's bring you up to speed. Waters Empower 3 software is a chromatography data system which, when connected to chromatographic instruments, assists with the management of raw data and test results through data acquisition, processing and reporting. Needless to say, this generates heaps of data, complex calculations and reports, but simultaneously it also addresses data integrity and compliance through the availability of electronic signatures and automated audit trails. The built-in calculations, while elaborate and plentiful, or sometimes not enough to handle the requirements of the laboratory, and a shift is made towards manual calculation, be it through spreadsheets or by calculator among others. And that is where these fabled custom fields come in. In this blog, we will take you through some of the best practices for implementing and validating Empower custom fields in your laboratory.
Devising an implementation strategy
Custom Fields consist of input fields and calculations that allow the user to input required values and receive a result as output. These results can be numerical, logical or text-based, depending on requirements and the custom calculations used. But before you run off to implement an entire series of custom fields, first check if this calculation is not readily available within Waters Empower 3, such as a complex relative standard deviation formula. If these default functionalities are not sufficient, a switch to custom fields is necessary.
Let’s take a closer look at both types:
Input custom fields are either text-based (such as a lot number), or can be numerical (such as label claim). They are used to add these values that Empower does not possess inherently but are still needed for more complex calculations. Or they can be simply used to document additional information (such as stability testing conditions).
Calculated custom fields are used to perform calculations where default Empower functionalities are not able to meet the test method requirements. These Custom Fields automate the calculation process, while also removing the need to transcribe data (and thus more chance of generating mistakes) for manual calculation methods. When these fields are validated, it immediately reduces the review time required as well, as only input values need to be checked.
As is usually the case, it is a great idea to create a work instruction or user guide on how and when to use these fields. Complement this with some training sessions, as working with custom fields requires some time to get used to this new way of working.
Another useful practice is to create these custom fields in a generic manner:
Give custom fields a generic name, such as Percent_Label_Claim instead of Percent _Paracetamol.
Make calculations as generic as possible. Empower 3 custom fields are great at selecting specific information to make all necessary calculations. Use these functions to generalize the used formulas where possible.
Applying both guidelines will allow you to more easily and often reuse existing custom fields.
Of course, when all these custom fields are implemented and are grouped with all other available information, finding the correct piece of data might seem like looking for a needle in a haystack. But never fear, with Empower 3 you can make “Summary-by-All”-reports, which means that entire sample sets can be combined into one fully customizable report. Within you can show whichever information you want into adaptable and easy-to-use tables. Additionally, these reports are also where electronic signatures come in.
The shift from using individual reports, one per sample, to a completely integrated and standardized report also reduces the number of documents created and, in direct correlation with this, the amount of time spent on review.
Validating an Empower 3 project
Implementing something new without going through the proper compliant channels is not done. This is valid for the implementation of custom fields as well: it needs to be proven that the custom field is working correctly, as dictated in the test method. How do you go about this? Let me put in some basic recommendations:
Create an SOP describing the procedures to follow when developing, qualifying and implementing custom fields and standardized reports within Empower.
As part of the validation process, user requirements and validation protocols can and should be created for the developed fields and reports. Additionally, a comparison with the manual calculation should be documented manual calculation.
If you followed one of my previous tips, working in a generic manner, previously validated custom fields can be leveraged with minimum testing.
Lock custom fields and reports to avoid tampering and/or user creativity.
Follow these and you’re basically ready for take-off.
Summing up your benefits
Implementing custom fields and reports provide a number of important advantages:
There will be a significant reduction in transcription errors, deviations and investigations related to Empower.
Collecting all data in one place (or Empower 3 project in this case), leads to increased data integrity.
Less time spent on data analysis, review, reporting and training of (new) users.
Increases operational efficiency by allowing more products to be tested and tested products to be reviewed in the same amount of time.
By following the recommendations described in this blog, developing and validating custom fields and reports can be done quickly, paving the way for your laboratory to implement a process that is a less time-consuming, more accurate and less susceptible to errors, increasingly traceable and user-friendly.
Blog by Kenneth Poupaert
Tip: Join our Automated Calculation Processing webinar on Tuesday April 21nd at 15:00.