When it comes to digitally integrating essential systems, processes, and tools, manufacturers and laboratories in the life sciences have traditionally lagged behind their counterparts in other industries. Those who continue to cling to the antiquated strategy of using disparate systems for specialized production activities now find themselves falling behind and missing many opportunities for growth.
Alas, life sciences manufacturers have new opportunities to combine the capabilities of advanced technologies through stable application programming interfaces (APIs) that turn disconnected tools into a unified system of force multipliers. This newfound power of innovative tools working in concert signals the arrival of a new era of unprecedented data connectivity, collection, and contextualization.
The value of integrated technologies
The integration of enterprise business systems and production floor equipment allows manufacturers to push and pull data without manual transcription. But for today’s life sciences manufacturers, the integration of essential systems and devices isn’t simply the automation of manual tasks. It’s a means for them to streamline operations and get products to market faster. The digital integration of core systems, batch records, and equipment is a modern necessity for companies needing a competitive edge in today’s fast-moving regulatory environments.
Life sciences companies that embrace a modernized approach to digital transformation and connectivity enjoy a host of benefits that largely fall into two main categories: greater efficiency and better quality. Let’s take a closer look at the specific quality and efficiency gains that can be achieved through integration.
Enhanced efficiency
When efficiency is maximized, it ultimately translates to lower overall production costs. Some of the specific efficiency benefits that connectivity enhancements provide include:
Real-time data capture/transfer
Connecting enterprise systems with advanced tools like state-of-the-art sensors enables the automatic capture and transmission of equipment data in real time. Elemental Machines accomplishes this with its Element-C and Element-D devices, both of which are designed to protect valuable lab equipment assets from risk.
Elemental Machine’s IoT sensors capture ambient environmental conditions across the manufacturing and lab space along with device-specific operating and usage conditions. After retrieving data, the device securely transmits it directly to the Elemental Machines LabOps platform, which provides interactive monitoring and transforms the data into insights via state-of-the-art data science. Some of the data streams that can be captured in real time include:
- Temperature
- Humidity
- Usage of specific equipment data
Simplified user activities
Connecting production systems and devices via an easy-to-use software solution like MasterControl Manufacturing Excellence simplifies manufacturing execution.
MasterControl software is specifically engineered to be easy for line operators and production workers to learn and use. This ease of use not only leads to broad and sustainable end-user adoption, but it also delivers tangible improvements to key manufacturing operations and product quality key performance indicators (KPIs) in a short timeframe and at a relatively low cost.
More focus on higher-value work
Enhanced connectivity frees up resources and workers’ time so they can be directed toward the core activities for which they were designed and hired to do. By eliminating the manual transfer of information and automating labor-intensive production processes, quality managers, plant line supervisors, operators, and managers can focus on improving the quality and throughput of their product, resulting in right-first-time production every time.
Better overall quality
At the center of manufacturing in the life sciences is quality. Products can not be released unless quality can be verified and validated. Therefore, optimization of quality control processes will help speed the entire production process.
Heightened visibility
Digital connectivity provides end-to-end visibility into operational processes and as-executed data that most organizations currently have locked in paper documents, including data relating to lines, batches, or lots. Purpose-built technologies empower operators to implement quality at the source so that every output and task in the production process presents a new opportunity to establish quality and compliance.
Real-time alerts
A connected system that provides meaningful alerts can inform workers in real time if a process or a piece of equipment is out of normal tolerance. This not only helps keep compliance on track, but it also ensures reproducibility.
Greater accuracy and data integrity assurance
Managing production records manually, with every step of the process undertaken by hand and on paper, often leads to inaccurate or missing information on the production record due to transcription errors. When production records are automated and digitally linked, it virtually eliminates the occurrence of these types of data entry errors.
The technology partnership between Elemental Machines and MasterControl is the ideal example of coordinated advanced tools working in concert to enhance data accuracy. Elemental Machines devices can securely send specific raw or processed data to MasterControl electronic batch records (EBR) throughout the entire quality control process. Advanced integrated tools like these not only automate data monitoring and capture, but they help ensure data fidelity and reliability as well.
The digitally connected future
Given the direction, data science is headed and the speed with which it is advancing, prediction is the next phase of modernized production. The integration of systems, devices, and data lays the foundation for next-level activities like predictive maintenance, a capability for which companies like Elemental Machines and MasterControl are actively developing machine learning (ML) technologies.
In the very near future, companies in the life sciences won’t just gain efficiency benefits from predictive insights — they’ll need predictive capabilities just to compete. In fact, of the industry executives and quality managers recently surveyed by BCG, more than 60% believe that predictive analytics will significantly affect quality performance and the bottom line within the next five years. According to the BCG researchers, “The expected increase in importance suggests that investments in predictive analytics for quality management will be a major source of competitive advantage.”
Regardless of how markets and regulations evolve down the road, one thing is certain in the life sciences: the future of manufacturing and laboratories will be digitally connected with quality.
James Jardine is the editor of the GxP Lifeline blog and the marketing content team manager at MasterControl, Inc., a leading provider of cloud-based quality, manufacturing, and compliance software solutions. He has covered life sciences, technology, and regulatory matters for MasterControl and various industry publications since 2007. He has a bachelor’s degree in communications with an emphasis in journalism from the University of Utah. Prior to joining MasterControl, James held several senior communications, operations, and development positions. Working for more than a decade in the non-profit sector, he served as the Utah/Idaho director of communications for the American Cancer Society and as the Utah Food Bank’s grants and contracts manager.