Environmental Monitoring in a Digital World: Opening the Doors to Scalability
In the pharmaceutical industry, environmental monitoring (EM) plays a critical role in ensuring the safety and sterility of products. But as production increases, companies find that traditional, paper-based EM processes simply can’t keep up. High manual workloads, fragmented data, and limited visibility often make it harder to maintain compliance and demonstrate control. As a key illustration, a study showed that 40% of manual EM steps are irrelevant and unproductive, which questions on the efficiency and opportunities of performance sustainability.
Jakub Dragun, Quality Control Consultant for a Cell & Gene Therapy company, discusses turning to 3P® ENTERPRISE, a digital and automated EM solution to modernize their quality systems and prepare for growth.
Why traditional EM is holding you back
Jakub explains it simply: “The traditional [EM] method is completely not scalable.”
Traditional EM processes rely on physical records, isolated teams, and time-consuming data transfers. As facilities grow, so does the complexity – more samples, more operators, more risk for errors or inconsistencies. Scaling this system means scaling the inefficiencies.
Inefficient procedures contribute to rising costs by extending analysis times, generating operational errors, and requiring additional resources. The fact that 62% of companies do not measure the cost of non-quality represents a critical gap in operational performance management. In contrast, digital EM processes allow organizations to centralize data, automate routine steps, and gain real-time visibility – resulting in a leaner process that’s ready to expand without sacrificing control or compliance.
Digitalization: More than just going paperless
Digital EM isn’t just about replacing paper with screens! It’s about unlocking insights, ensuring traceability and overall improving process efficiencies.
“Taking our EM to the digital world gives so much more tools to demonstrate control over manufacturing processes.”
A digital approach like 3P® ENTERPRISE integrates all stages of EM, from sample planning and collection to incubation tracking and data reporting. It ensures data integrity, reduces errors and associated costs, and enables instant access to historical trends and compliance reports. The result? Continuous operations with maximum uptime.
“We were looking for a leaner, faster EM system that would give us the same level of compliance and assurance, if not better.”
Traditionally, meeting high quality standards has slowed down EM processes. But with digital EM, Jakub noted that they were able to move faster without losing reliability.
By automating sample workflows and data entry, EM teams can shift their focus from paperwork to decision-making. This reduces reporting delays, minimizes transcription errors, and shortens turnaround times—crucial in fast-paced manufacturing environments.
Digitalizing Environmental Monitoring: Customer voices
Hear about Jakub’s take on 3P® ENTERPRISE and how the automated solution helped his company scale up their Cell & Gene Therapy manufacturing.
Like Jakub at Autolus Therapeutics, you can unlock the future of pharmaceutical quality with automated environmental monitoring. With 3P® ENTERPRISE, you can experience streamlined processes, enhanced reliability, and superior results.
