Although rarely in the limelight, bioanalytical labs play a critical role in the pharmaceutical industry. Supporting both preclinical and clinical studies, these labs perform the bioanalysis needed to help developers understand the efficacy and safety of potential therapeutics.

To make sure they provide a high-quality service, bioanalytical labs need to function as smoothly and efficiently as possible, and fully comply with any regulations. Unfortunately, many labs lack the right digital infrastructure for productive, easily compliant workflows. Consequently, labs end up with convoluted processes that make completing many essential tasks laborious and time-consuming, including:

• Exchanging data with sponsors;
• Tracking study sample history from receipt to disposal; and
• Complying with Good Laboratory Practice (GLP) and 21 Code of Federal Regulations (CFR) Part 11, as well as Food and Drug Administration (FDA) Bioanalytical Method Validation and European Medicines Agency (EMA) guidance documents.

To simplify their procedures, bioanalytical labs need digital infrastructure to provide full visibility and control over their entire workflow. As a result, labs can better manage their data, making sure it is visible, accessible, has integrity, and allows them to prove compliance more easily. But that’s not all. Advanced digital infrastructure goes beyond data management; it can bring many other benefits, such as automated regression analysis, which help labs maximize their productivity and minimize costs.

Streamline data management with a LIMS

There’s no denying that the bioanalytical workflow is exceedingly complex (Figure 1). It can therefore be tricky to find a digital solution that gives you complete oversight and management across the workflow.


One such digital solution is a lab information management system (or a LIMS). A LIMS can help better manage data and processes at each step all the way from study initiation through to close-out, making sure that your lab is productive and that it offers high quality services.

This article delves into how a LIMS supports the entire bioanalytical workflow below. For simplicity, the different steps of the workflow have been grouped into method management and validation/study design, sample management, sample analysis, reporting and Quality Assurance (QA) review, and study archival (Figure 2).

Study design and method management and validation

Every good bioanalytical workflow starts with a well-designed study. But many different factors need considering, such as whether the study needs blinding, and what groups are needed. And even the most well-designed study needs to be flexible—unscheduled events mean that users need to be able to add or remove samples. Unfortunately, the wrong digital infrastructure can make study design rigid, stopping you from making these vital changes.

Fortunately, a LIMS offers dynamic study design, successfully overcoming these challenges. First, there’s flexibility in the design itself. You can import a study design, and simply add samples to your current design—for example using data from a spreadsheet. Or you can build a study design from scratch, based on the samples you’ve received.

Method management can be just as complicated for labs. They must create, review, and optimize their method, and ensure they validate it through quantitative measurements to make sure that it gives accurate, precise, reliable, and reproducible results. Without the right digital infrastructure in place, efficient method management—particularly when multiple users need to make changes—can prove challenging, and validation even more so.

A LIMS can streamline method management and validation for many different assay types, including multiplex, anti-drug antibodies (ADA) and neutralizing antibodies (NaB). The functionality of a LIMS allows users to collaboratively review and optimize methods, for example, making the overall process more efficient. Additionally, a LIMS also enables users to evaluate their methods through several predefined reports for quantitative measures such as accuracy, precision, reliability, and reproducibility. What’s more, an advanced LIMS assesses run performance against a Standard Operating Procedure (SOP) with defined acceptance criteria.

A LIMS also gives you flexibility in amendments. As your study evolves, you can easily amend your protocol by adding or removing samples. These features, taken together, make study design a breeze.

Sample management

Efficient sample management is a vital part of a productive bioanalytical workflow. But with older digital infrastructure, recording all the necessary sample data can be difficult and time-consuming, particularly if you do it manually. Such cumbersome process inefficiency also makes it more challenging to prove compliance, where you need to have sample receipts, and must be able to prove the full chain of custody.

As you might expect, a LIMS has many features to help simplify sample management. For example, with a LIMS you can record and document all sample shipments using barcodes, making it much more efficient than manually entering sample information. A LIMS can even let you define storage units down to the plate position within a storage box using the barcodes, making it simpler to track them. Recording all this sample data allows personnel to easily provide auditors with chain of custody records, therefore simplifying compliance, too.

Sample analysis

The core component of the bioanalytical workflow is sample analysis, where labs perform the tests that gather the vital data (such as pharmacokinetic, pharmacodynamic, and immunogenicity) needed to support drug development. However, consistent, reproducible testing in compliance with Standard Operating Procedures (SOPs) isn’t an easy task; a task that proves even more challenging when outdated digital infrastructure lacks supportive measures.

A LIMS, when equipped with dedicated modules, provides practical support for SOP adherence, guiding users through tests such as immunogenicity assessments. It also guides users through the tiered approach of performing screening, confirmatory, and neutralizing assays. Furthermore, a LIMS has capabilities for calculating assay cut-points, generating automated flags for samples outside of the cut-point, and discerning reactive samples, significantly streamlining your analysis.

Another hurdle analysts face with sample analysis is making sure that all the data obtained from the tests is centralized, accessible, and visible. In many labs, there is no way to automatically collect and centralize the data from different tests. As such, personnel are forced to collate the data manually, causing a bottleneck in the workflow.

Addressing this challenge, a LIMS integrates with different bioanalytical instruments to automatically centralize your analytical data and make it more visible. What’s more, it can allow users to perform PK/ADA calculations and analyses in the system, simplifying the workflow even more.

Reporting and QA overview

Towards the end of the bioanalytical workflow, after sample analysis, labs need to process their data, generate reports, and transfer the data to clients. As part of this, personnel need to review the history of attributable changes in the audit report for QA. For labs with dated digital infrastructure and manual data collection, these steps can be incredibly problematic.

A LIMS quickly provides study reports and sample life cycle documentation, streamlining QA review. Additionally, a LIMS makes data processing more efficient by performing automated regression analysis, which is centralized and supports linear and non-linear models. Personnel can also quickly and easily collate and build a full study report that includes method validation experiments, assay performance and study data. These reports are even customizable to meet each client’s requirements and can report data in CDISC SEND format. Overall, a LIMS significantly streamlines report generation and data transfer.

During every step of the bioanalytical workflow, labs must comply with all relevant regulations. As mentioned earlier, ensuring compliance can be laborious with older digital infrastructure. However, implementing a LIMS can significantly simplify the compliance process. For example, it can generate E-signatures, simplifying the validation of compliance with regulations such as 21 CFR Part 11.

Study archival

Archiving the study completes the workflow. During this stage, it’s important to maintain complete data traceability, and to make sure that the CRO can easily pass studies to the sponsor. It’s also essential to restrict study access, so no one can make any changes. And finally, labs need to ensure they meet record retention requirements. With older digital infrastructure and manually recorded, siloed data, it can be extremely time-consuming to ensure data traceability and security.

Adopting a LIMS can effectively simplify study archival and bolster data security. Firstly, it ensures complete traceability from study initiation through to closeout while keeping full records of long-term sample storage or destruction. Centralized data within a LIMS also simplifies study transfer from CROs to sponsors.

Secondly, a LIMS can archive the complete study record in compliance with any record retention requirements. Lastly, and arguably most importantly, it grants study access to authorized personnel only, ensuring data security. Collectively, these features aid your bioanalytical labs in achieving effective and compliant sample archival.

An end-to-end solution for high-quality, productive, and compliant processes

Inadequate digital infrastructure can have a range of consequences for a bioanalytical lab, impacting both its internal operations and its external credibility and reliability. For these labs to be productive and offer high-quality services, they must have complete workflow oversight, efficient sample management, and compliance assurance.

Implementing a LIMS will help labs better manage their data and processes all the way from initiation through to study close-out. It does this by making data more visible and improving its quality, while maintaining the integrity. Through these capabilities, labs that adopt a LIMS can ultimately streamline their workflow for higher productivity and keep their processes compliant. 

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Arpit Singh is a Product Manager responsible for development of Thermo Scientific Watson LIMS software. At Thermo Fisher Scientific, in the past 8 years, Arpit has contributed to multiple software product releases. Arpit holds a Master of Technology degree in Bioinformatics from Delhi Technological University, India.