IDBS Blogmicroscope showing the burden of manual data transcription in bioanalysis

IDBS Blog | 27th June 2018

How Your LIMS Can Help Reduce the QC Burden in Bioanalysis

The data integrity of your bioanalytical process will determine the quality of your study and with the right solution, the entire process can flow with a seamless assurance.

As the pace of life sciences discovery accelerates, teams increasingly rely on laboratory information management systems (LIMS) for sample tracking and other lab operations. This is seen across modalities, from small and large molecule pharmaceutical companies to the rapidly growing pool of cell and gene therapy developers. Laboratory operations and laboratory personnel who rely on pen and paper lab notebooks instead of a LIMS not only hold back discovery and time to patient but put their organizations at risk from data integrity issues that accrue at every stage of product development, from R&D and process design through clinical trials and commercialization. Bioanalytical laboratories that deploy a laboratory information management system at appropriate stages of the product lifecycle will reap the benefits of improved data quality for experiments as well as batch data capture, improving data analytics, lab processes and the data security needed to safeguard IP.

Despite the value of a laboratory information management system to simplify data capture for lab experiments and ensure data integrity for lab operations, a LIMS can create digital barriers for the pharmaceutical industry.

Most major bioanalysis laboratories use a LIMS for sample tracking and lab data management within a study and to ensure data integrity and enforce standards so tests are conducted consistently. However, a LIMS can leave several gaps that manual processes are still required to fill. This includes critical information associated with projects, studies and daily runs, which is not captured or tracked in the LIMS but is still essential to the completion of study reports – for example, analytical instrument setup, method validation documentation, sample QC and system calibration records. Typically, this information resides in paper lab notebooks or study binders.

There is no arguing that laboratory informatics solutions such as LIMS, scientific data management systems (SDMS), electronic document management systems (eDMS), and instrument control software have significantly advanced the data integrity and volume of bioanalytical data being generated. But could you be using your LIMS to do so much more? Pharmaceutical companies can now expand their laboratory information management system beyond sample tracking, ensuring data integrity at every step.

Integrate your LIMS with new technology

Modern bioanalytical labs require a robust data management solution that improves workflow efficiency, simplifies the application landscape for the scientist and ensures data integrity to minimize the significant QC burden of each study.

By integrating LIMS solutions with other software, you can manage your operations, accelerate lab processes, improve data accuracy and reduce your backlogs without having to deploy another standalone system.

IDBS Polar for bioanalysis has numerous specific tools for integrating with LIMS solutions that can help streamline and enforce synchronization while maintaining data integrity. For instance, it can automatically synchronize with the hierarchy setup (and security model) so that users have a familiar workspace within their electronic study binder that automates quality control.

A record of the sample sequence, plate layout and instrument settings can also be extracted from your LIMS and presented as part of the daily run worksheet. Using the run ID, data can be retrieved without the need for manual file transfer or copy/paste functions that jeopardize data integrity. This can significantly reduce the QC burden and simplify the analyst’s day-to-day workflow. To maintain the integrity of the validated environment, Polar for bioanalysis can be restricted to “read-only” rights within the LIMS.

As data analysis for non-compartmental studies is often done in a LIMS, the study result can be imported directly into Polar for bioanalysis. In addition, users of Polar for bioanalysis have the option to exchange information with third-party analysis tools and include output results in analysis reports. Polar for bioanalysis includes a comprehensive statistical engine as well as extensive graphic capabilities, giving users the option to use this native functionality rather than third-party software.

Implementing a single platform

By implementing a single platform for comprehensive capture, storage and reporting of bioanalysis study data that integrates with existing laboratory infrastructure, you can begin adding value and dramatically reducing the QC burden in bioanalytical laboratories without compromising quality.

You could even reduce bioanalysis study cycle times by more than 50%. Want to know how? Check out our bioanalysis solution brief here.

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