LIMS - Management Skills
Today, lab software productivity is less about computing power and more about user-friendliness and integration. As Moore’s Law predicted, our computers can process orders of magnitude more 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) have lowered the costs of accessing computing power so today it’s more about the idea, not the infrastructure to operationalise it.
These days we are much more discerning about user interfaces and usability: we expect our laboratory software to behave as intuitively as our smartphones. 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 stabilising 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 adapt and ensures people and processes achieve maximum productivity.
How can more user-friendly software find its way to the pharmaceutical QA/QC lab and what role do today’s integrated informatics solutions play to help move this process along? 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 scientists and technicians who are documenting their day to day activities. Lab informatics software should 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 lab managers and directors who need to manage day to day laboratory operations and make it run efficiently. For them, the first and perhaps most critical step is that this information is captured in the system. 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 non-conformance 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 and workload. 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 rationalised 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 utilise 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. Take large molecule drug production, where complex production processes and evolving regulatory oversight are data dependent. Large molecules can be more difficult to characterise 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 QA/QC is a system that is designed for how today’s laboratory staff work. 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 enables a comprehensive approach to production quality and compliance.
Intuitive software is both useful and integrated. Seems simple but many manufacturers 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 friendly to the way QA/QC is done today, integrated informatics systems can be drivers of greater productivity as production and regulatory environments become more challenging and complex.