Anwenderbericht

New Regulations Increase Pressure for Change

This multinational life sciences corporation manufactures a wide range of healthcare products, including pharmaceuticals and medical equipment. In early 2023, their field inventory department faced new regulatory requirements for distributing orthopedic surgical kits used in joint reconstruction, trauma, spine, and cranio-maxillofacial procedures to a regional network of hospitals.

With the new regulatory requirements in place, this corporation was concerned the additional compliance activities will significantly delay the time to effectively distribute their life-saving surgical kits. They specifically emphasized that in GxP environments, they must maintain legible, time-stamped logbook records for their inbounding process of the kits to ensure compliance. As the primary record for documenting the raw data of events and inventory, a missed entry, improperly written log or compromised notebook can severely hinder traceability and accountability.

Finding a logbook solution that improves productivity while ensuring quality and compliance was no easy task for the Staff Quality Engineer supporting 15 field inventory sites across the US. It not only had to track which operators fulfilled the surgical loaner kit orders, it also needed to document the inbound processing of returned kits and replenishment of any consumables used in the previous operation prior to making the loaner kits available for its next surgery.

Paper is Time-Consuming and Error-Prone

This corporation’s pilot project ended with a tough lesson - manual documentation would disrupt operators who intake and ship hundreds of kits per site per day.

They realized that each kit could take over 10 minutes to process with paper documentation. This cycle time was unacceptable, especially when their workflow was still prone to error and risked non-compliance. Instead of focusing on continuous improvement efforts, this team was buried under paper and required labor just to store these documents off-site or scan for electronic storage.

The team quickly decided to pivot to using a digital tool to document the process. Their search led them to Tulip, and they never looked back at paper again.

This company chose Tulip because of its ability to deploy a custom solution quickly without the hassle of mastering a complex, generic, off-the-shelf logbook software solution. Their immediate need was to manage inventory, manage changes in kit types, and visualize their operations on a dashboard. With clear use cases in mind, it was easy to compose 3 apps for each function in order to document the entire loaner kit inbounding process.

Within 3 months, the life sciences corporation deployed a digital logbook solution with Tulip apps at 15 field inventory sites across in the United States, with 125 user accounts created.

Eliminating Manual Documentation Leads to an Estimated $500,000 Yearly Savings

In the 2 months after deploying the solution with Tulip, the company documented 48,331 kits with 1.5 million components across the 15 field inventory sites. Over 98% of all kits were inbounded with a simple barcode scan with no manual typing or mouse clicks.

Digitizing the process with Tulip apps turned what could have been a 10 minute manual process to a few seconds. With 125 operators using the new solution, this equates to about 11,000 hours per year, resulting in about half a million in time cost savings per year.

The digital logbooks solution with Tulip not only improves efficiency of the inbounding process, but makes retroactively accessing the documentation seamless. If the quality engineer wanted to know who worked on which kit on which date, finding that information would take under a minute with Tulip’s digital record keeping. This improves productivity, accountability, and transparency within the department.

Many eLogbook solutions alleviate some of the burden of compliance with improved documentation functionality, however, Tulip goes beyond that by delivering contextual, real-time information on a user-friendly interface.

Flexible Multi-Site Deployment with Reliable Governance

The life sciences company found global deployment of the digital logbooks solution to be seamless.

Tulip, as a cloud-native platform, facilitated multi-site deployment much faster than a traditional manufacturing software solution could. Cloud deployment means that app configuration and approval can happen from any location and does not require on-premise resources.

The enterprise company runs Tulip on a private cloud hosted on Microsoft Azure to manage their data with the highest level of security and control, while retaining the flexibility and scalability of a cloud-based architecture.

Tulip’s data architecture also simplifies multi-site management by breaking down data-silos, allowing real-time data to be accessible from anywhere with aggregated views across all 15 sites to gain accurate insights for process improvement.

The Staff Quality Engineer highlighted that user management features in Tulip makes it simple to grant the right users with the right level of permissions to ensure everyone on their team has the tools they need, without risking unauthorized changes.

One Validated Platform, Numerous Possibilities

In less than 6 months after discovering Tulip, this life sciences company leveraged the Tulip platform to transform an analog process into a digital one, achieve full compliance with new regulations, and gain a holistic view of a process where data was previously inaccessible –- all with minimal disruption to their operations.

Now that they have validated Tulip as a platform, the time-to-value to digitize other processes with Tulip will be even faster than this initial implementation.

Looking forward, the team already has 20+ ideas of how to leverage the Tulip platform to further improve the current process and explore new use cases that will improve other facets of their field inventory operations. Some of these ideas include adding expiration date documentation, running time studies, and error-proofing kit assembly. Right now, their biggest challenge is figuring out which idea will make the biggest impact to start implementing first!