Few QA/QC lab techs still record their data by hand, but this is only the first step – labs must adopt a smart infrastructure that drives quality throughout the organization. In many cases, an integrated informatics solution is the engine that drives this culture of continuous process improvement.
FDA & Quality by Design
In 2004, the FDA introduced Quality by Design (QbD) in “Pharmaceutical cGMPs for the 21st Century - A Risk- Based Approach.” 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. The FDA’s goal was to improve pharmaceutical companies’ productivity, ensure patient safety and prevent drug shortages. Informatics plays a critical role in ensuring that organizations realize the improved product quality and operational efficiency that adherence to QbD principles provides.
The Informatics Solution
To meet QbD requirements, QA/QC laboratories need a tightly controlled process that drives predictive analytics and prevents substandard products. An end-to-end informatics solution warns the organization before nonconformances occur by monitoring critical product attributes in near real-time. 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 built on QbD principles are followed in day to day operations. The system can guide users through any laboratory procedure, providing technicians with the direction they need to execute processes consistently. It also assures laboratory management that good laboratory practices and standard SOPs are being followed.
An SDMS lets managers integrate instruments across the lab and centralize data capture, allowing for long-term data archiving and data visualization. An SDMS saves both original raw data files from the instrument and normalized representations in XML, allowing it to interpret data from multiple instruments using different software or file formats. The final product specification is defined by comparing the analytical results to determine which formulation and process parameters yield the best product. An SDMS integrated with the LIMS reduces paperwork and manual review time, which in turn improves efficiency, productivity, consistency and quality. SDMS also provides access to archived files for as long as necessary, enabling more efficient and defensible regulatory reporting.
A LIMS remains a critical part of any pharmaceutical organization’s infrastructure. Today’s LIMS go far beyond the management of samples, tests, and results; they also provide resource management, allowing organizations to forecast sample volume and resource needs. Many also offer dashboard views that allow organizations to identify any data that is approaching warning or failure limits. These lab management activities are essential.
Having a smart infrastructure built on a state-of-the-art informatics solution enables another critical benefit in the lab: automation. Even smart instruments must undergo regular performance verification, and because instrument failure or miscalibration can negatively impact quality down the road, any risk is unacceptable. A LIMS can save considerable time by helping labs automate critical maintenance procedures. When all systems are aligned, the convergence of people, processes and technology is transformative.
Going Beyond Paperless
Today’s paperless lab can also be called an “integrated” lab. The ability to manage all lab processes in a tightly integrated solution dramatically streamlines laboratory operations while minimizing cost of ownership. An example of this is SampleManager LIMS, which includes built-in functionality for LIMS, LES and SDMS. With LES functionality available as part of a LIMS implementation, SOPs and methods are automatically established electronically so that all lab personnel can use the LIMS as their guide.
It’s easy to see this focus on informatics as a lab-centric view of the pharmaceutical business, but that would be a mistake: the ability to run efficient labs and protect brands by ensuring quality are both enterprise-level concerns. As such, the LIMS needs to be fully integrated with ERP systems. In fact, many requests coming into QA/QC laboratories are actually initiated in a manufacturers’ ERP system, which often serves as the bridge between a manufacturing execution system (MES) and other systems.
In many organizations, a LIMS is a standalone investment: if the lab needs additional software, such as an ELN or SDMS, those systems are then purchased, implemented and supported separately. By instead having all these capabilities resident in a single system, labs can reduce cost of ownership, increase ease of training, streamline compliance and achieve better overall quality control. All of this is possible across vast geographies and contractual partnerships. Organizations that haven’t done so already need to make this year a major inflection point for laboratory technology, especially for QA/QC. The case is clear that the costs of inaction outweigh the investment required for change.