Pharmaceutical Company

Introduction

In the process-laden operations of pharmaceutical manufacturing, a large multinational biopharmaceutical company leveraged Tulip’s Frontline Operations Platform to digitize standard operating procedures (SOPs) for a complex equipment line changeover procedure. By converting the process to validatable Tulip Apps, the company dramatically reduced the time required to perform the procedure, minimized errors and increased visibility into the process.

The Challenge

The need to document and operate within standards is critical for pharmaceutical manufacturers, and for this team, the documentation lengthened the line clearance procedures time to 14 days. Ensuring complex equipment used to manufacture pharmaceuticals is thoroughly cleaned between batches is critical and the extensive process is challenging to adhere to for new and experienced technicians alike. The process required operators to follow 80-page paper standard operating procedures which lists every detail of the actions to be performed on the machine. Following such extensive procedures was difficult for operators and if each step was not done correctly, the fix could be extremely costly and time-consuming.

Without sufficient reporting, the team lacked visibility into the process and how long the process took to execute as a whole. Furthermore, the company did not have data regarding how long each sub-process took and what users were having the most difficulties with.

The Solution

The pharma company leverages Tulip’s Frontline Operations Platform to streamline line clearance processes within their facility. By implementing a suite of apps to manage their line changeover process the team cut the time required to perform the clearance, while also reducing errors. Tulip apps work seamlessly together and provide a full solution that surfaces previously unavailable data to the facility’s management.

One main app that acts as a dashboard lists all the tasks that the team needs to complete. As the team progresses through the process, individual workflow apps provide necessary information for how to perform the tasks. Furthermore, the apps ask users to record information on the changeover that was previously unavailable. Technicians record values critical to quality through checklists, numerical entries and open fields as they undergo the procedure. With Tulip’s comprehensive GxP feature set, the team built a validatable suite of apps that improved the previously cumbersome process.

The main router app stays up-to-date as the operation progresses. Production line supervisors can stay current with regards to which tasks have been performed, and which are still in progress.

Benefits of Implementing Tulip

The largest benefit is a reduction in the time required to perform the changeover. Before using Tulip, the changeover process took 14 days. With the use of the Tulip solution the customer created, the same process takes 3 days.

Following 80-page standard operating procedures is complex, even for the most experienced technicians. By making the apps interactive and requiring inputs, the number of costly mistakes was drastically reduced.

The challenges of training new technicians are alleviated as the information on the process is presented in a user-friendly interface.

Capturing detailed breakdowns of the time required to perform each task provides actionable information on which the team can prioritize improvements to the process. By targeting error-prone and time-consuming processes within the overall procedure, the team is more quickly able to generate improvements to the process.

Tulip Frontline Operations Platform enables customers to seamlessly connect to systems that contain critical information to the app. Pulling in data from project management software, the customer has been able to provide technicians with relevant information when necessary.

Conclusion

Tulip’s GxP comprehensive feature set enables validatable high-value use cases to drastically improve labor-intensive operations such as this one into an intuitive procedure that is easy to follow even for new technicians. The benefits of deploying this solution were immediately apparent and will continue to provide value for years to come.

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