The Case for User-Friendly Informatics in the Pharmaceutical QA/QC Lab

By Trish Meek, Director of Product Strategy, Thermo Fisher Scientific

It’s hard to believe but today, lab software productivity is less about raw computing power and more about user-friendliness and integration. As Moore’s Law predicted, our computers can indeed process orders of magnitude more today than even a decade ago. But putting more transistors on a chip isn’t all that’s making modern lab workers more productive: new business models, system architectures and software delivery models play major roles too. Cloud computing and infrastructure-as-a-service (IaaS) in particular have lowered the costs of accessing computing power so much so that today it’s more about the idea, not the infrastructure to operationalize it.

All the computing power in the world isn’t useful if the software designed to access it is poorly designed. And we’re all much more discerning about user interfaces and usability: we expect our laboratory software to behave as intuitively as our smartphones. After all, laboratory employees are unlikely to be preoccupied with lines of codes and processors – they’re focused more on how easy the software is to use.

Intuitive software is useful software, and users will require little encouragement to make it central to their daily regimen. Equally important, well-designed software is a stabilizing constant in a workplace that is increasingly marked by turnover and change. Staff may leave and projects may transition, but an informatics system never loses track – from workflows to SOPs, it helps new staff quickly adapt and ensures that all people and processes are achieving maximum productivity at all times.

Now begins our conversation about how this wish for more user-friendly software can find its way to the pharmaceutical QA/QC lab and what role today’s integrated informatics solutions can play to help move this process along. So what should an informatics system offer its users in a pharma QA/QC setting? First, it is important that we differentiate the system users and how the software can provide the most value. The first group is the scientists and the technicians. These users are documenting their day to day activities. At the very least, lab informatics software should that walk these users through common tasks and automate their SOPs; the ability to record, transcribe and manage all data digitally; prevent them or warn them about instruments requiring system maintenance or calibration and expired solutions or reagents.; and user-friendly functionality for reporting data.

The second group is the lab managers and directors who need to manage the day to day operations of the laboratory and make it run as efficiently as possible. For them, the first and perhaps most critical step is that this information is captured in the system. For them, the system needs to ensure that SOPs and regulations are followed ensuring good scientific process and valid results. Once the process is executed and the data captured, they need sophisticated data analytics to monitor data trends and stop nonconformance before it occurs.

Intuitive software is also integrated software. Many laboratories today operate with disparate systems that could – but don’t – share interrelated data that if combined would reduce complexity, workload and, at times, frustration. The ability to network systems is critically important to modern labs – silos are not conducive to productivity.

An integrated informatics system eliminates silos, combining the complementary capabilities of a laboratory information management system (LIMS), scientific data management system (SDMS), laboratory execution system (LES) and an electronic laboratory notebook (ELN). It’s not enough to have each of these systems – they must be integrated and the communication among them must be rationalized and automated. Labs that manually share data between systems are not only sacrificing productivity, they are introducing risk.

The single-system requirement leaves only two real options: either buy the entire system from a single vendor or ensure that all systems can share data via digital interfaces or utilizing integration tools that can translate and communicate data. The system must enable bidirectional data flow, including the ability to acquire and assimilate data directly from all laboratory instruments, regardless of vendor or format. This means that data must be assimilated from the most complex laboratory instruments, like mass spectrometers or chromatographs, as well as basic lab essentials like Ph meters, balances and scales.

While productivity has always been important to pharma QA/QC labs, greater complexity and more onerous regulation is sharpening the focus on productivity-enabling systems and tools. An often-cited example is large molecule drug production, where complex production processes and evolving regulatory oversight are intensely data dependent. Large molecules can be more difficult to characterize during production, and this requires greater vigilance and reporting. The environment is significantly more dynamic, so too must be the approaches to QA/QC.

It would be impossible to manage today’s dynamic production environment with data in silos. The data must be integrated and it must be actionable at all times. Consider Quality by Design (QbD) principles introduced by the FDA in 2004. How can a manufacturer monitor quality at every stage of the production process if that data isn’t readily accessible and easy to manage? The answer is that they cannot, and this means that an integrated informatics system, combining a LIMS, SDMS, LES/ELN functionality, as well as full integration capabilities with the full complement of lab equipment and enterprise systems, isn’t a luxury, it’s a necessity.

The key to highly functioning and dynamic QA/QC is a system that is designed for how today’s laboratory staff work. We can now be fairly certain that the necessary computing power will be there, but not all software is created alike. It must have an interface that adapts to users, end-to-end automation that mitigates risk and integration that enables a more comprehensive approach to production quality and compliance.

Intuitive software is both useful and integrated. Seems simple, but yet many manufacturers still struggle with interfaces that neither match how they work nor pull in data from all the systems on which they rely. By focusing on the users, making the system truly friendly to the way QA/QC is done today, integrated informatics systems can and should be drivers of greater productivity even as production and regulatory environments become more challenging and complex.

For more information go to www.thermoscientific.com/sm11

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Related Topics and Keywords

Informatics, QA/QC, Quality Assurance, quality control, Thermo Fisher Scientific, Thermo Scientific