Informatics infrastructure enables the fully integrated pharmaceutical laboratory. Trish Meek reports
In a 2013 report, Gartner analyst Michael Shanler advises that manufacturers ‘prioritise end-to-end informatics investments and align metrics for innovation, domain expertise, operational efficiencies and quality’. His recommendation is based on an observation that today’s laboratories ‘are, for the most part, disconnected’.
The move to a connected laboratory is driven by the productivity objectives Shanler outlines—but also by significant technology improvements. The paperless lab has been discussed for the past 20 years, but it is finally materialising.
Nowhere is this more evident than in pharmaceutical quality assurance/quality control (QA/QC) laboratories. Few QA/QC lab techs still record their data by hand; but, while this is a critical step, it is only the first step in a bigger overhaul process. There’s far more to becoming a paperless lab than simply eschewing paper.
Labs must adopt a smart infrastructure that drives quality, not only in the lab, but throughout the organisation. An integrated informatics solution is the engine that drives quality product release and a culture of continual process improvement.
Quality by Design
In 2004, the FDA introduced Quality by Design (QbD) in ‘Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach’. While this concept is not new to many industries, this was the first attempt to apply these principles to the pharmaceutical industry. Quality by Design is built on the concept that well-understood products and processes are more efficient and produce higher quality products resulting in less product nonconformance.
The FDA’s goal was to improve pharmaceutical companies’ productivity, to ensure patient safety and to prevent drug shortages in the marketplace. Uncompromising quality is essential to any pharmaceutical company. Informatics plays a critical role in ensuring that organisations realise the improved product quality and operational efficiency that adherence to QbD principles provides.
End-to-end informatics
QA/QC laboratories need a tightly controlled process and well managed laboratory to drive predictive analytics and to prevent substandard products before they occur. An end-to-end informatics solution warns the organisation before nonconformances occur by monitoring critical product attributes creating a proactive versus reactive environment. Laboratories address these needs through the use of several systems: Lab Execution Systems (LES), Scientific Data Management Systems (SMDS), and Laboratory Information Management Systems (LIMS).
LES has become a critical component of today's paperless lab ensuring that quality processes are followed in the laboratory and that the methods built on QbD principles are followed in day to day laboratory operations.
LES drives users through any laboratory procedure in a stepwise fashion. This provides technicians with the direction they need to execute processes safely, and in a consistent manner. It also assures laboratory management that good laboratory practices are used and that SOPs are being followed by experienced and newly trained laboratory personnel.
Maintaining a consistent approach to activities like sample preparation, instrument calibration and maintenance and analytical testing is critical to a good scientific process. Lab managers can then be certain that all of their results are a true assessment of final product quality.
An SDMS lets you integrate instruments across the lab and centralise data capture, allowing for long-term data archiving but more importantly, data visualisation from the archive – all accessed from the LIMS.
An SDMS archives the original raw data files from the instrument along with a normalised representation in XML, without the need to restore the data to the original instrument workstation or install the instrument software on every computer. The real scientific data and the results gleaned from it are a critical part of QbD.
The final product specification is determined by comparing the analytical results to determine which formulation and process parameters yield the best product. As part of a paperless lab environment, an SDMS integrated with the LIMS reduces paperwork, manual review time and data transcription, which improves efficiency, productivity, consistency and quality while reducing costs dramatically.
SDMS also provides secure access to archived files for as long as necessary, and enables more efficient and defensible reporting to regulatory authorities.
LIMS remains a critical part of any pharmaceutical manufacturing organisation’s infrastructure. Today's LIMS goes far beyond just the management of samples, tests, and results. It also provides resource management allowing organisations to forecast fewer sample volume and resource needs. It provides dashboard views that allow organisations to see how their lab is operating and identify any data that is trending towards warning or failure limits. These lab management activities are essential, but organisations also need to be able to drive the day to day operations of the laboratory as well.
Having a smart infrastructure built on a state-of-the-art informatics solution at its core enables another critical benefit in the lab: automation. Even smart instruments must undergo regular performance verification. And how often this is done depends on many factors, including the frequency of use. Because instrument failure – or having a system go out of specification – can negatively impact quality, production or compliance down the road, any risk is unacceptable. A LIMS can save considerable time helping labs adhere to precise rules and requirements, automating critical procedures on pre-defined schedules.
When all systems are aligned, the convergence of people, processes and technology is transformative. Problems arise when these systems aren't fully integrated and these disparate systems become out of synch.
At a macro level, breakdowns occur at three key points: data capture, data transcription and data management. Put another way, the key to an efficient lab that delivers uncompromising quality is having smart instruments within a smart infrastructure. This starts with SOPs for highly standardised methods and processes, which are handled by the LES, and includes raw instrument data generated by the analytical instruments used in those experiments, all of which is handled capably by the SDMS.
What lab managers really want is a truly connected system that provides lab management, drives lab operations and integrates all of the data-generating sources and ties all that data together in one centralised location. A modern LIMS needs to be a complete informatics infrastructure by providing a LIMS, SDMS, and LES in one.
Going beyond paperless
Today’s paperless lab can more aptly be called an integrated lab. The trinity of LIMS/LES/SDMS enables lab managers to achieve full instrument integration, manage their methods and workflows, retrieve and archive any kind of raw laboratory data and export those results across the organisation to ERP systems, for example, all in whatever format is required by recipients.
The ability to manage the entire process in a tightly integrated solution, one that functions as a single piece of software, dramatically streamlines laboratory operations while minimising the cost of ownership, implementation, validation and ongoing maintenance.
An example of this is SampleManager LIMS, which includes built-in functionality for LIMS, LES and SDMS as well as integration technologies. What’s more, when labs plan for such seamless integration it enables lab managers to codify a 'do it right every time' process approach, which is in alignment with QbD processes, providing the transparency necessary to identify and remove non value-add steps, while lowering the cost of training new staff.
With LES functionality available as part of a LIMS implementation, SOPs and methods are automatically established electronically so that for any lab personnel, new or seasoned, the LIMS acts as their workflow, manual and constant guide.
It’s easy to see the LIMS, LES, SDMS ‘stack’ as a lab-centric view of pharmaceutical business, but that would be a mistake. The ability to run efficient labs and protect the brand by safeguarding product quality are both enterprise-level concerns. As such, the LIMS needs to be fully integrated with ERP systems: in fact, many work requests coming into QA/QC laboratories are actually initiated in a manufacturers’ ERP system, which for many companies is the bridge between its manufacturing execution system (MES) and other systems such as the LIMS.
Conclusion
In many organisations, a LIMS is a standalone investment, managing workflow and sample testing and generating appropriate reports. If the lab needs additional software, such as an ELN or SDMS, those systems are then implemented and sometimes, but not always, integrated with the LIMS so that lab operations are more streamlined and data is easier to manage.
In a QA/QC lab, however, a LIMS that is pre-built with LES and SDMS functionality, delivers end-to-end workflow and data capture that is literally designed for quality. The benefits of having all these capabilities resident in a single system are myriad, starting with lower total cost of ownership, ease of training and administration, streamlined compliance and better overall quality control. And all of this is possible across vast geographies or contractual partnerships, all of which can be managed holistically.
Organisations, that haven't done so already, need to make this year a major inflection point for laboratory technology, especially within the QA/QC function. After all, the evidence is stacking up that the costs of inaction clearly outweigh the investment that is required for change.
Trish Meek, Director of Product Strategy, Thermo Fisher Scientific.
