Driving Better Outcomes for Quality Control Labs

Today's advancements in pharma and biotech would have been unthinkable just a few decades ago. Brand-new modalities and other progress have made an impact on the world, earning recognition for the research and development teams behind these breakthroughs in drug discovery. However, behind the scenes are the teams ensuring quality, safety, and efficacy of both groundbreaking treatments and everyday medicines: QC laboratories.

Despite their critical role in delivering safe and effective treatments to patients, many QC labs have trailed in modernizing their infrastructure in comparison to research and development labs. The reality is that many are ensuring quality with outdated software, disconnected data, and paper-based workflows. This environment is prone to delays and bottlenecks and increases the risk of human error.

The consequences of inefficiencies facing QC laboratories extend far beyond the bench. Regulatory audits have become increasingly complex and costly, and mistakes in the lab impact both time to market for new therapies, and critical patient supply for commercial drugs.

There is an opportunity to modernize QC and move beyond complex patchwork solutions that contribute to errors, lack real-time visibility, and require high maintenance costs. But are QC labs ready for modernization and different ways of working? They must be if companies want to move toward a digital, agile, and scalable QC center of excellence.

Entering a New Era for Advanced Quality Control Labs

Introduced in the 1980s to replace paper ledgers, laboratory information management systems (LIMS) aimed to enhance compliance through digital data capture and audit trails. These systems, built on the tech of the time—client-server architectures—relied on on-premises servers, databases, and software installations, requiring extensive IT support and validation efforts.

While these systems helped pave a path toward advancements in QC processes, the heavy customization to align with industry specific laboratory processes, ongoing master data management, and periodic major upgrades have consumed IT resources and driven up costs. These demands often exhaust lab and IT budgets, preventing QC labs seeing beyond their LIMS instance.

It is unfortunate that after more than 30 years since the introduction of LIMS, paper-based workflows remain prevalent in QC laboratories for tasks such as sample tracking, instrument logbooks, and test execution documentation. Manual data transcription between instruments, paper records, applications, spreadsheets, or reports increases risk of errors at every step. The outcome is slower testing cycles and increasing regulatory vulnerabilities.

Maintaining the traditional approach of using paper to execute QC lab processes is contributing to challenges in talent retention and operational productivity. Efforts to reduce paper usage through additional digital tools, such as electronic lab notebooks (ELNs) and laboratory execution systems (LES) typically function in isolation and are popular initiatives in QC. Yet, they create complexity for the lab analyst and reviewer by adding another application for interaction, necessitate complex integrations to share data with core LIMS applications, and compound on the challenges of managing master data - which must be kept perfectly in sync, a difficult activity in an environment constantly executing change control.

The approach isn’t an ideal long-term solution since maintaining master data across disparate systems can disrupt integration and undermine data integrity. These digital tools also require ongoing validation and maintenance, a costly expense as companies try to drive innovation in QC.

Companies are beginning to challenge the status quo for QC, adapting a visionary approach to laboratory operations where lab management, execution, and review can be completed in a single “full-stack” application offering industry standard processes. This consolidates the QC technology ecosystem and eliminates the need for paper processes for a more efficient and effective manufacturing lab.

Advancing QC Operations with a Cloud-Based LIMS

Moving beyond the traditional legacy solutions and the heavily paper-based environments of today, QC leaders are turning to a unified, cloud-based LIMS to manage lab processes. These teams are adding solutions on a cohesive software-as-a-service (SaaS) platform that can bring together quality assurance (QA) and QC while eliminating the need for on-premises servers and continuous validation.

The reduction of physical servers alone offers significant cost savings and provides scalability to deploy the new systems across multiple sites. When evaluating a LIMS, look for a solution that enables the execution of core QC functions, including sample management and chain of custody, inventory and equipment management, test method execution, and reporting. The solution ideally would span across industry standard workflows for release testing, stability, and environmental monitoring. Being able to complete these tasks within a single application can streamline lab operations, improve lab productivity, and strengthen compliance.

Here are additional considerations for an advanced cloud-based LIMS:

• Embedded stepwise test method execution and standardized workflows based on industry best practices can eliminate the need for a separate lab execution system (LES)
• Instant access to current, effective procedural documentation in LIMS prevents use of outdated instruction to improve compliance
• Features such as advanced automated data capture, keyword search capabilities, and instructional multimedia can enhance accuracy and efficiency during testing

Figure 1: The Benefits of a True SaaS LIMS Solution

Source: Veeva

A cloud-based LIMS provides companies with regular updates, delivered incrementally and validated to meet regulatory requirements (see Figure 1). This keeps the platform aligned with industry standards without requiring extensive IT intervention. The updates, informed by user feedback, also introduce enhancements that minimize operational disruptions. Not having on-premises servers reduces infrastructure costs and validation burden and allows for rapid deployment.

By consolidating data and processes into a single cloud LIMS, companies can reduce manual transcription and digitally capture diverse data types, including numerical results, text entries, and instrument data, and validated calculations. This improves the review process and enhances data integrity, taking companies one step closer to a connected QC lab.

Making a Case for Quality Assurance (QA) - QC Connectivity

Connecting QA, QC, and training on a single platform is an innovative way to drive greater operational efficiency while maintaining rigorous standards, including GMP and US Food and Drug Administration (US FDA) regulations. With access to real-time data across the functions, teams can trace batch data and results and execute cross functional, end-to-end workflows to minimize compliance risks. Companies with a connected QA and QC landscape can gain clear visibility into laboratory processes and optimize resources for a more productive QC operation.

For example, with connected QA and QC, lab leaders can verify analyst qualifications against integrated training records before test execution, preventing unauthorized personnel from conducting analyses and ensuring adherence to standard operating procedures. When deviations, such as test failures or nonconformances occur, the system can enable immediate investigation initiation within the QC environment and seamlessly link to QA for efficient collaboration for resolution and documentation.

Another way that having connected QA and QC helps lab teams is by providing real-time access to QC test results and certificates of analysis. The data empowers QA teams to expedite and instill greater confidence in batch release decisions while tracking the impact of QA-driven changes, such as revised specifications or change controls stemming from QC activities like ongoing tests, samples, and stability studies.

Automated workflows can also guide staff through multi-step test processes, track equipment and sample usage, and capture results digitally, eliminating redundant manual data entry and enhancing accuracy. The approach simplifies IT management, lowers operational costs, and provides a more collaborative, compliant laboratory ecosystem.

Building a Connected Lab of the Future

While systems outside QC have become more innovative and robust, QC teams deserve the same technological advancements to address operational complexity brought on by the development of advanced medicines and therapies. Change is within reach as cloud-based LIMS solutions built on flexible and compliant platforms are available today. By moving from legacy systems and processes to the cloud, QC labs can streamline daily operations and build a strategic, responsive quality control ecosystem.

Supported by a leading LIMS, organizations can realign QC’s scope with its original intention of complete compliance, regardless of complexity, and efficient product release. QC teams will then be able to deliver safe, high-quality therapies to market faster, and with more confidence.