Case Study: Improve your lab’s efficiency and data compliance with a chromatography data system
Article Jun 12, 2018 | By Peter Zipfell, Thermo Fisher Scientific
Image: Thermo Fisher Scientific
Chromatography labs must constantly adapt to varying requirements for higher throughput, increased sampling, and stricter regulations. The time pressures surrounding these changes can make them challenging to achieve without proper assurance of data accuracy and validity. Reliance on manual entries and reporting can quickly turn sour if errors are introduced along the pipeline. As a result, labs are turning towards a paperless vision that can automate and quicken processes, improving efficiency, enhancing compliance and simplifying potential audits.
Implementing a chromatography data system (CDS) can help commercial labs evolve with changing client needs and regulatory guidance, whilst maintaining robust data collection and compliant reporting. Broughton Laboratories is an analytical laboratory that supports method development and validation projects across pharma and other sectors, along with providing quality control and stability services. To increase lab efficiency and improve data verification processes for overall time savings, ultimately supporting their customer service and turnaround time goals, Broughton implemented and upgraded their CDS.
When Broughton’s analysts were asked what is needed most in a chromatography lab software system, user-friendly, intuitive, and compliant top the list . Upgrading the CDS not only delivered these benefits, but also substantial operational efficiency gains and the ability to spend more time focusing on getting results that are reliable and accurate.
A more efficient labWithin a modern CDS, an eWorkflow™ is a set of rules that captures all the unique aspects of a chromatography workflow and guides the operator through a minimal number of choices needed to create a complete, correct sequence with predefined files and a well-defined structure. eWorkflow™ procedures minimize the amount of training required and take you from samples to reliable results in a minimum number of steps.
Broughton found that by applying an eWorkflow™ to each test method, they could create an effective and efficient mechanism for sample sequence creation, set-up, and instrument configuration. This provided time savings of up to 50% for each test method as well as enhancing the reproducibility of each run. They used a design qualification document built into the CDS to assist with eWorkflow™ set-up by specifying workflow layout and content (including test scripts and example data) to apply templates for testing the expected outcomes and documentation for quality assurance.
How custom variables can helpAfter running an experiment through analysis and interpretation, automated integration parameters assist in quickly transitioning from peak reporting to results, eliminating manual errors or over-interpretation of data. Any variable that is not already part of the core CDS can be added, taking custom analysis and data reporting to the next level. Custom variables can be as simple as creating column ID at the sequence level, which can then be used to document and monitor column use, or other variables for more in-depth analysis when adjusting scales in chromatogram plots, ensuring consistent data presentation and easy comparisons. Custom variables can also be applied at the sample level for composite weight and density, or the component level with labelling for custom calculations to make sure the required data is included for each analysis.
Broughton uses the power of custom variables as triggers, initiating events based on certain criteria. For example, if system suitability testing is required, but only for specific injections, a sample level custom variable added as a trigger value can be created for those injections required for the test. When the CDS encounters a pre-defined variable, it automatically triggers the system suitability test for that injection. Triggers are also helpful in improving efficiency while maintaining compliance during the management of new peak detection. Typically, manual changes must be made in a template to report a new peak. However, the upgraded CDS allows for the simple addition of a new peak to a component table and selection of appropriate triggers for automatic reporting. This increases the efficiency of new peak reporting, since templates do not need to be modified for each new peak detected.
The necessity of templates and audit trails
Data integrity is a necessity in any regulated environment operating under good manufacturing practice (GMP). Templates can help maintain compliance and conform to regulations such as EudraLex vol. 4 annex 11, 21 CFR part II, or standard GMP, where increased expectations are focused on data integrity. These regulations outline requirements for file management and storage, providing a full chain of evidence from sample check-in to report out. The ability to control files and sequences is an important aspect of a CDS, in order for laboratories to store and easily access frequently used files in method testing and for increased traceability when modification, review or approval is needed. Controlled files are effectively validated, which in turn provides evidence of working to compliance and can save time in data verification.
Automated data control results in precise audit trails that can track changes by listing every event that has occurred in each file or report generated. It even facilitates the comparison of file versions from initial creation to the final locked version. If a validated template has not been changed, then no further checks are required, instrument conditions do not have to be reconfirmed, and analysis redone. Overall, time spent on data verification stages of analysis using a CDS can be significantly reduced by up to 80% compared with manual verifications.
Implementing a modern CDS can enhance workflows, increase productivity and provide the tools that are required in order to move to an electronic based system. In turn this will simplify the task of meeting compliance and data integrity will be ensured through audit trails that are reliable and complete. This is exemplified by Broughton Laboratories, but what could a modern CDS do for your workflows and paperless vision is the question!
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