Break Down Silos on Your Shop Floor

Life sciences companies are digitizing and integrating their processes more than ever, with 73% of manufacturers planning to increase their investment in smart factory technology over the next year, according to PricewaterhouseCoopers. However, many of the core systems that have already been implemented—like enterprise resource planning, manufacturing execution systems, and laboratory information management systems—remain siloed by department and continue to rely on manual processes to function, especially when it comes to maintenance and asset management.

These disconnects perpetuate the inefficient processes they were meant to solve, hindering production and affecting data integrity—and ultimately product quality. Without a single integrated system, it is more difficult to coordinate maintenance activities across teams and gain timely insights. Plus, documentation is spread across a variety of systems, meaning there is no single, authoritative audit trail.

Let’s think about a simple, real-world example:

1. During a production run, a granulator (or another piece of equipment) has a failure.
2. Line worker reports the issue to their supervisor or plant manager.
3. Plant manager enters the issue into work order system or sends email to the maintenance team.
4. Maintenance team receives the work order and prints it out to assign to a technician. They then alert QA to create a quality event.
5. Technician assesses the work order and tracks down the equipment necessary to fix the granulator, which may be out of stock or unavailable.
6. Once the required equipment is procured, the technician fixes the granulator, which now needs to be recalibrated.
7. Technician lets the maintenance team know the repaired status in-person or via email.
8. Maintenance team manually files a request for a third-party to calibrate the granulator.
9. Metrologist comes in to calibrate it and records information in a third-party system to generate the calibration certificate — and then sends it manually via email to the maintenance team.
10. After receiving the certificate, the maintenance team can then close the ticket and put equipment back online.
11. Maintenance team provides an update and documentation to QA to support the quality event/CAPA process.
12. All documentation—the original issue, quality event/CAPA, work order(s), calibration certificate—is stored/copied in disparate systems, and the quality team must consolidate it manually.

This process is manual and requires a number of touchpoints, but it can be simplified with Nuvolo Connected Workplace for Life Sciences. Working from one source of truth, your teams can manage all shop floor activities, ranging from corrective maintenance and calibration to warehouse and inventory. This platform brings all teams together so they can work from a single source of truth to:

• Digitize processes to reduce manual activities, including scheduling and tracking of manufacturing, quality, maintenance, and warehouse processes
• Break down silos and streamline information sharing by removing the need to extract and transfer data across disparate systems
• Improve real-time reporting and quickly gain full visibility into your asset lifecycle to support strategic business decisions
• Establish quality, safety, and regulatory compliance with out-of-the-box traceability and 21 CFR Part 11 and Annex 11 adherence

As you can see, the process becomes much more streamlined with Connected Workplace:

1. During a production run, a granulator (or another piece of equipment) has a failure.
2. Line worker opens Nuvolo on any device and reports the issue.
3. Manufacturing team is alerted in the application and assigns the issue to a technician based on availability and skill. The work order includes all equipment required and the technical manual(s) to fix the issue, prompting the warehouse to send the necessary items to the technician. An automated alert can be sent to QA with the details for the quality event.
4. The technician fixes the granulator and marks it complete in Nuvolo, which automatically triggers a call to a third-party calibration vendor.
5. Metrologist calibrates the granulator and records the information in Nuvolo, closing the ticket and allowing the equipment to be used again. QA has visibility to the work orders, so they are immediately aware of the resolution and have all details for completing the quality event/CAPA process.
6. The quality team has a single stop to get full history on the granulator for potential audits.

With all teams using Connected Workplace, the process is more efficient, and all information is stored in the same place. This improves cross-team collaboration and data accuracy. Additionally, because information is consistent across teams, management can easily pull reports to assess performance and make better business decisions.

Interested in learning more? Contact us today.