THREE DIGITAL STRATEGIES TO MODERNISE QUALITY CONTROL IN BIOPHARMA LAB OPERATIONS

Author: Jason Boyd, senior director, Vault LIMS, Veeva Systems

With the proliferation of quality control (QC) digital projects to improve lab efficiency, more QC leaders are adopting standalone applications focused narrowly on a specific need. This can lead to individual biopharma labs using different tools to execute processes, making connectivity and unification difficult. Without a holistic quality data and workflow view, these disjointed solutions, coupled with increasingly complex lab workflows, cannot deliver the expected outcomes or planned ROI.

The opportunity to transform the QC lab is driving LIMS market growth. Although positive change in QC labs operations is happening, more work remains to address growing system silos and complexity while improving quality and agility.

Quality leaders looking to drive change in QC can implement three strategies that will help them advance toward an agile, digital, and connected lab. The approach can streamline sample management, test execution, and lab investigation processes for faster batch release and reduced inventory expenses.

Start With The Problem

While every biopharma organisation is unique, lab managers are expected to find improved ways to streamline their lab throughput. Rather than starting with “this specific tool will solve our challenge,” approach your organisation’s key technology strategists (think CIO or head of IT) to bring together identified business opportunities with the organisation’s technology pursuits.

Often, QC includes a mix of manual processes that rely on a mix of paper, spreadsheets, homegrown solutions and vendor-provided point solutions. Looking at the complete quality ecosystem, and evaluating improvement options that modernise multiple business processes, can make a significant positive impact on the organisation. For example, if analysts use various systems to upload and download files across several departments, a single document repository for all document collaboration can increase right-first-time completion; while relieving some of the pain they experience daily logging in and out and choosing the right system for each document type.

Since QC labs need more than one application to bring together their operations, mapping out end-to-end business processes can help leaders determine what systems or activities need to be streamlined. This process helps assess what to keep, what to expand, and what to decommission. Key considerations include whether the applications currently being used are sustainable, driving cost savings, and aligning with the organisation’s roadmap.

Connect People Across Biopharma Labs And Teams

Driving successful transformation across quality requires an investment to establish a comprehensive quality platform. Assemble a team representing the complete quality business process to define an achievable timeline, detail the priority of capabilities, and establish a strategy for organisational change management.

Consider consulting firms and vendor services as an extension of this team, to ensure all the capabilities and expertise needed to address any bumps encountered along the journey. Combining internal leaders, industry experts, and partners can provide the right mix of people to ensure a successful transformation.

Prioritise Technology That Facilitates Collaboration

Once you have the right people on board, decide whether building or buying technology makes the most sense. Developing a matrix for technology selection that encompasses current and future needs and new and existing products, services, and support can drive the conversation forward. The goal should be to enable more connection and collaboration across quality and manufacturing. When evaluating technology, consider:

• Master data management: determine the level of harmonisation or rationalisation for master data within the project and select systems; to be publishers and consumers of data definitions. This should also provide the flexibility and agility to support your long-term data interface strategy without requiring an exhaustive upfront investment

• Anytime, anywhere access to information: arm teams with real-time data and visibility into documents for improved collaboration and better productivity across lab operations, with a goal of bringing all necessary data to each decision point

• Applications built on the same platform: information sharing is seamless in this environment, increasing visibility and efficiency across teams

• User experience: an intuitive UI, robust training, and ongoing services drive faster process improvements and ROI

• Automation: industrystandard workflows automate quality processes and remove tedious, repetitive work, freeing up lab managers and allowing them to focus on high-value deliverables

• Connectivity: open APIs allow for easy integration with other lab systems, like enterprise resource planning (ERP) or lab equipment, streamlining processes, improving efficiency, and speeding batch release times

• Vendor alignment: identify a partner that fits in with your organisation’s goals, is committed to innovation and continually invests in building out their core competencies, and has a solid track record.

Modern systems on a single technology platform can make it easier to unify the quality ecosystem, from quality assurance (QA) to training to change control and QC. Completing this transformation streamlines end-to-end processes for more efficient execution.

ENDING THE “WHAT’S WHERE” QUESTION

Having a connected solution for all quality data and documents will end the “we don’t know what’s where?” conundrum. Because creating and using a spreadsheet is often viewed as the easiest solution to an existing challenge, organisations need to establish a comprehensive business process supported by an intuitive platform. This will stop the swivel chair approach where personnel pivot from one screen to another, often logging in to different systems simultaneously.

By bringing an opportunity into the broader quality ecosystem, establishing a team of key stakeholders, and conducting a thorough technology evaluation, lab leaders can drive speed and agility across the manufacturing lab. This can optimise lab management and accelerate batch release, improving operations and delivering more value from QC.

Looking at the complete quality ecosystem, and evaluating improvement options that modernise multiple business processes, can make a signi cant impact on the organisation.

Nearly half (48%) of senior decision-makers working for drug development companies or manufacturers said data silos derailed the efficiency of cross-functional collaboration in their organisation. This was a key finding of research commissioned by Aspen Technology, which surveyed 400 global professionals with expertise in drug development or manufacturing to find out where drug manufacturing is headed in the next 3-5 years.

According to the research, larger pharma businesses in particular are more likely to see data silos hinder internal collaboration efforts. More than half (53%) of businesses with total annual revenues of more than US$1 billion said these silos derailed the efficiency of cross-functional collaboration in their organisation versus 44% for companies with annual revenue between US$50 million and US$249 million and 47% for companies with revenues between US$250 and US$999 million range, who said the same.

Raman Bhatnagar, vice president and general manager at Aspen Technology, said: “Information silos are often created by lack of connectivity between data sources across departments, which can hinder efficiencies across the product lifecycle.”

He added: “One way of breaking down the barriers is by deploying products that utilise a common data ecosystem enabling real-time data access.”