How To Create FDA-Compliant Process Visibility In A Pharmaceutical Production Facility

At first glance, pharmaceutical manufacturing centers appear to be exceptionally difficult candidates for digital transformation.

The FDA’s 21 CFR Part 11 outlines strict criteria under which electronic records and signatures are considered acceptable, so paper-based documentation is still common.

Segregated clean rooms create barriers to any personal communication. They look something like this:

And frequent cleaning and validating processes introduce plenty of opportunities to waste time while communicating with different groups of personnel.

Every pharmaceutical manufacturer has a plan to achieve compliance with these FDA regulations. But, many manufacturers struggle to measure and improve their operational efficiency under these conditions.

That’s why I spoke to a Futura Automation consultant about the series of no-code apps that he created in order to run a client’s operation more effectively while remaining compliant within the rules of the FDA.

This consultant will be using a no-code database to track the status of various rooms around their production space. In this system, when a team member uses a simple app on an iPad outside of each room, the database is automatically updated, and the appropriate team (cleaning, validation etc.) etc. receives a notification.

Here’s an example of the home screen where a manufacturing engineer can see the status of all rooms in one place:

Here’s how this digital manufacturing expert is setting up the system in one facility.

Like many drug production spaces, this facility contains a series of closed clean rooms, as shown above. They use “projects”, like batches of individual tablets, to organize production processes.

Each project gets assigned to a series of rooms, and that room can only handle one operation from one project at a time. There are a common series of steps for every operation, for example:

1. Start operation
2. Finish operation, contact cleaning team
3. Finish cleaning, contact validation team
4. Finish validation, indicate that the room is ready for production again

So, every project is rigorously regimented. The series of processes must occur in a specific order. Bottlenecks will stop an entire project.

In a paper-based system, there is no good way to share the status of individual rooms with the entire team. The consultant had previously used different color magnets to indicate the status of a room to team members that were walking by the room. However, this does not help a manufacturing engineer that is trying to improve efficiency.

“Magnets and manual methods do not inform us about bottlenecks in our production process. After we assign a project to a room, like a batch of tablets that need to be produced, we have a hard time tracking status from start to finish.”

Instead, the consultant is creating a no-code database that allows him to track all of the rooms in one place. Each room has an iPad that a team member presses upon entering and leaving the room. It looks like this:

When a team member uses the iPad to indicate that the room has been cleaned or used in production, the status is shared with a central table in a no-code database, which then updates the overall “Rooms View” that was shown at the start of this post.

With the magnet notification system, individual operators needed to find a cleaning team within the facility in order to indicate that their previous room needed cleaning. Or, they could add a note on a central board that the cleaning team would periodically check.

Both of these systems create wasted time between operations. So, the manufacturing engineer wants to create a real-time notification system so that each team is notified as soon as they are needed.

To accomplish this, he triggers an email that is automatically sent to the correct team as soon as the room changes status. This will reduce the wasted time between projects.

Paper logs also do not provide any actionable data for improving operations, according to the consultant.

“We scan all our paper logs into a computer for regulatory purposes, but is difficult to use for continuous improvement since the data cannot be easily analyzed and times are not tracked.”

Instead, his system of operations apps automatically track the time that an app remains in a specific status. Since every team member checks in and out with the app, he automatically receives granular data on the time that each room spends in each status.

Also, he can track bottlenecks in the process and learn which operations are slowing down production. Unlike other batch processes, his facility does not have the flexibility to easily add more machines or people to an individual problem. He is limited by the number of rooms in the entire space.

Although this engineer must create the logic to organize all this data, all of these insights can be gathered via two taps: check-in and check-out to each room. From his admin interface, he is able to assign projects to rooms, so the data is automatically tracked on the individual project level as well.

Here’s an example of the interface for assigning a project to an individual room:

The consultant plans to use this system alongside the existing paper log book system.

“Team members will continue to write in the logbooks in each room in order to comply with FDA standards. However, since the apps running on the iPads are simply used for operational efficiency, they do not need to comply with 21 CFR part 11 guidelines.”

If you are interested in using no-code apps in your pharma production space, sign up for a free trial of Tulip today. A Tulip team member will provide guidance on how to set up this system in your facility.