Building a Business Case for a New LIMS

As one of the last steps in the batch release process – and often the critical path – quality control (QC) organizations are being challenged to complete test execution, review, and release swiftly.

With constrained resources and an overreliance on manual, paper-based processes, even with a traditional laboratory information management system (LIMS), the result is reduced operational efficiency, limited scalability, and compliance risks. A modern QC LIMS can mitigate these challenges, regardless of whether a sponsor conducts manufacturing and QC testing internally or through a network of external partners.

With a modern QC LIMS delivered as software-as-a-service (SaaS), organizations benefit from an always-current application that provides industry-standard digital workflows down to the bench, GMP, and automation. This enables enhanced efficiency, right-first time, and strengthened compliance without expanding headcount.

Evaluate QC Technology Landscape

The first step towards modernizing the QC lab is understanding the current solution space. Compare legacy on-premises systems, often built on client/server architectures or vendor-hosted, with modern SaaS solutions and their benefits. Each delivery approach involves unique costs, timelines, and resources for implementation and ongoing maintenance. These variables can help you determine which will fit your business and deliver a positive return on investment (ROI).

The initial exercise can be eye-opening. Subscription-based SaaS solutions alleviate the need for hardware, extensive validation, and disruptive version upgrades, which can lead to hidden costs. Consider the solution’s features and capability roadmap. Is the solution built to tackle the specific challenges within pharmaceutical GMP manufacturing? Is the delivered application a good fit for the business, or is it a lab commodity that requires extensive customization to support business processes?

Evaluate the solution’s user experience (UI/UX). Is it web browser-based, modern, and intuitive, or does it emulate the Windows operating system? Will your users quickly adopt and enjoy using the application in this modern, digital age, and will the use of this solution help to attract and retain top talent?

This thorough analysis is worthwhile, as a McKinsey & Co. report found that productivity can increase by 50-100% when high-performing QC labs transition to paperless systems and optimize testing processes. Here are six steps to make a business case for a new LIMS.

Step One: Analyze the Opportunity Cost of Manual QC

Many life sciences organizations rely entirely on paper-based manual QC processes, or a mix of legacy systems with paper-based processes, despite their detrimental effects on laboratory efficiency and product quality. Managing paper records is prone to errors, while manual QC workflows form bottlenecks that challenge detection and resolution.

The consequences of disjointed QC processes extend beyond the internal laboratory as managing diverse data formats and sources becomes a complex task. Even with an outsourced model, sponsors are accountable for ensuring that all production and QC stages comply with stringent standards for the safe and effective release of products. Without data visibility and status tracking across partner networks, the risk of non-compliance increases. Additional opportunity costs include:

• Risk of not meeting lab output goals
• Decreased readiness for audits and inspections
• Longer cycle times

For companies in late-stage clinical development, manual processes pose challenges during regulatory review. Replacing legacy systems and processes with a modern LIMS establishes extensive controls, enhancing preparedness for regulatory inspections.

Step Two: Evaluate LIMS on System Architecture and Domain

After analyzing the opportunity cost of maintaining the status quo in the QC lab, begin the evaluation of different LIMS offerings based on two key factors:

System Architecture:

On-premises LIMS

Legacy LIMS are implemented with on-premises hardware. It requires significant procurement and maintenance attention to launch and costly, disruptive upgrades to keep it up to standard. The history of these applications shows they are often highly customized to meet the needs of specific use cases, placing the full burden of the installation, operational, and performance qualification (IQ/OQ/PQ) on the customer.

Total cost of ownership (TCO) for legacy LIMS is often higher than expected due to infrastructure and validation costs, a significant IT footprint for integrations with other complementary applications, and overall system maintenance. For companies with lean IT teams, this approach is not always viable.

Cloud-hosted on-premises LIMS

Legacy applications are now offering a hybrid solution, delivering the same architecture as the on-premises application but in a vendor-hosted private cloud. An important change with this approach is that the responsibility for security, access, and (in some cases) general maintenance moves from the customer to the software provider. Still, hybrid clouds do not address challenges with scalability, maintenance costs, customer-specific customization, and perpetual version upgrades.

True SaaS LIMS

A true SaaS solution built on 100% vendor-managed cloud infrastructure is always current, making it easy to adopt innovations through regularly scheduled software updates. Cloud solutions deliver industry-standard workflows and best practices that can be tailored as needed and are pre-validated. The results are faster implementations, simplified maintenance, and lower overall TCO.

Domain focus:

Many LIMS solutions were designed to serve multiple lab-centric industries or scientific domains, rather than the specific needs of a particular industry. Assess whether the current and future capabilities of a LIMS are optimized for the GMP QC lab and C-level objectives within quality manufacturing.

Step Three: Find a Competitive Edge

Since reducing QC lab cycle times helps provide a competitive advantage, clearly articulate how a new, modern LIMS can help accelerate batch release and shorten time-to-market. Emphasize the outcomes that align with priorities. For example, underscoring how a modern QC LIMS upholds your organization’s commitment to superior product quality or how tailoring GMP can simplify and ensure compliance with evolving regulatory requirements.

For clinical-stage companies, modern QC LIMS solutions help facilitate business scalability as the volume of products, trials, release markets, and manufactured batches grows. By leveraging automation and standardized data management to compile submission materials, clinical-stage companies can enable faster and more efficient regulatory submissions.

Step Four: Define and Measure Key Value Metrics

A QC LIMS that encompasses a broad range of functionalities can deliver a rapid return on investment. For instance, many require test method execution in paper notebooks, standalone tools like laboratory execution systems (LES), or heavily customized electronic laboratory notebooks (ELNs). These are additional layers of technology that create complexity and increase risk for QC labs. A modern LIMS will equip QC teams with integrated digital capabilities, including embedded test execution, extending the digital experience to the bench. Using an advanced solution eliminates paper-based processes and reduces layers of complexity, lowering overall maintenance costs.

A business case outlines the specific metrics and timelines that can help demonstrate value. Short-term benefits may include reduced operational costs and faster implementation. Long-term benefits could include improved test accuracy and faster batch release times.

Step Five: Outline a Clear Resourcing Strategy

Securing an executive sponsor early on helps to strengthen the business case from the beginning. Leadership support behind a QC LIMS shows that QC modernization is a strategic business priority rather than an IT project. In addition to an executive sponsor, establishing a dedicated team of business process owners and subject-matter experts (SMEs) is crucial to effectively configuring, implementing, and adopting a new LIMS. Defining these resources helps drive project success and long-term value.

Include business process owners and SMEs across the quality ecosystem to ensure alignment. Deciding up front on the necessary integrations—for example, with document management, quality management system (QMS), or training systems—simplifies QC LIMS implementation. Include business process owners and SMEs across the quality ecosystem to ensure alignment. Deciding up front on the necessary integrations—for example, with document management, QMS, or training systems—simplifies QC LIMS implementation.

Deploying a modern QC LIMS requires fewer IT and QA personnel than traditional on-premises systems because it eliminates hardware installation. It also does not require extensive customization or IQ and OQ validation.

Step Six: Embed New Processes and Workflows

During and after QC LIMS implementation, organizations often face challenges managing change in process and user adoption. It is key to update standard operating procedures (SOPs) and build change management into the business case to minimize lab disruption and simplify the shift toward new ways of working.

Review and update SOPs in your content management system to align with the new LIMS. Using a digital training solution as part of this process can help with tailoring educational materials in a familiar format to make it easy for users to learn and remain compliant in day-to-day operations. Adapting to new ways of working often means adjusting the company’s operating model, so try to remain open to change.

Advancing With a Modern QC LIMS

Quality teams can reduce errors, enhance digital collaboration, and eliminate inefficiencies caused by manual processes by modernizing systems. This helps shift the focus to core responsibilities rather than navigating complex, disconnected tools.

A modern QC LIMS accelerates batch release, shortens time-to-market, and ensures compliance amid growing regulatory demands. By building a proper business case, lab leaders can establish a clear analysis, value, and strategy for adopting a new LIMS. The industry is rapidly evolving, making this a good time to move forward.