MANY DEVICE MANUFACTURERS RELY ON SPREADSHEETS OR PAPER RECORDS TO TRACK THEIR DEVICES POST-PRODUCTION. TODAY'S CLOUD-BASED TECHNOLOGY CAN TAKE TRACKING TO A WHOLE NEW LEVEL OF CAPABILITY.
Read on to see our recommended process for moving your device tracking into the cloud.
Step 1: Select the information you want to track
It starts with the top level devices themselves (do you want to split out various models or track all of a product family together). Once you have picked a certain device, then you need to decide how deep into the device you want to go. Some people use just the device level of tracking. Others dive deep into subassemblies, that allow for the service department to pull and replace sections of the device.
If you are in the implantable space, you likely just need to track the top level device information.
Step 2: Identify necessary data sources
Now that you know what you want in the cloud - where are you going to get it? It is unlikely (unless you deliver jsut a few devices per month) that you want to manually enter the data. Ideally, you would connect directly to your manufacturing ERP system. If you don't like manual entry and can't stomach the ERP connection - then the best middle ground is a .csv file in a form that the cloud based system expects and can work with.
Step 3: Define user access levels
There are lots of people in your ecosystem. They all need access to the system - but they need to be able to see and do different things. So, step 3 is to lay out your strategy for different types of users. You need to be able to set up the users.
Regardless of who is in the system, they are all going to need 21 CFR Part 11 compliant e-signatures. You can't know the passowords of the people in the system (even if you are the administrator). And, you need to make sure that the user actions can never be removed from the device history records that the system is maintaining (even if that user leaves).
Step 4: Trial Deployment
Now that you have a system up and ready, it is time to find the early adopters in your ecosystem and run through a prototyping phase of the new system. As you engage a select few in the organization, be sure and ask for their feedback. What do they like? What do they absolutely hate? What delights? What annoys?
Any move to the cloud is as much about people and change management as it is about technology management. It is critical to lead your people in a way that the early adopters have pride in the new system and feel great about championing it to their peers.
Step 5: Roll Out
Now that you have selected the data to track, identified the data sources, defined user access, and worked out initial kinks with early adopters - you are ready for a full-scale rollout. The first few weeks of the rollout will require a lot of hand holding as all of the members of your extended team become familiar with the new system. But, the benefits of cloud based data are huge - you can touch the data once, instantly generate regulatory compliance reports, and involve the whole ecosystem.
One of the biggest keys to moving to the cloud is ensuring a clean and simple user interface that assures the system can "self train" as much as possible. For more information on how MedDeviceTrack can help you with your migration to the cloud, click here to schedule a personal demonstration.