00:00 - 00:28
As a small private company. I was trying to do my best to manage our quality budget. We wanted to really evaluate the creation of records and the management of data, and configure robust processes to our needs. Now, with the implementation of Unifize, we were able to build out risk-based quality management system.

00:28 - 01:02
My name is Jarod Markley, quality and regulatory affairs director at Recovery Force Health. Recovery Force Health is a private medical device manufacturer based in Fishers, Indiana. Our first primary product was the MAC (Movement and Compressions) system, and we have recently added in pressure injury prevention products that allows that patient to progress with deep vein thrombosis prophylaxis. So when I joined Recovery Force Health in 2022, we were utilizing Greenlight Guru.

01:03 - 01:40
Large solutions that are out there today, either take what they have as a solution and conform your process to it. Greenlight Guru required every individual to have a full access license for us to even generate records, such as non-conformance or customer feedbacks. From what I recall with MasterControl, configurations took more effort for the functionality to be brought to fruition. Whereas with Unifize, we're able to build and configure robust processes to our needs.

01:41 - 02:16
Being scalable, customizable, implement very quickly a process that fits our needs, Unifize facilitates full traceability through our QMS. You know, product development to postmarket surveillance that we have so specifically like with 14971 and risk management. Whole cradle-to-grave development and post-market surveillance processes. Previously we were managed in spreadsheets. We've be notified by, "hey, I've got this product that I'll be bringing back a return material authorization".

02:16 - 02:45
And and based on that initial investigation, create that compliant record and have to copy all that information over manually. But now with our integrated processes within Unifize, we're able to take the information from the RMA, initiate that complaint. So then that way there's no loss in translation from one record to another and Unifize, able to pull in its intended use statement, based on the classification.

02:45 - 03:10
So I'm able to say, okay, just with one click on the MAC device, I'm able to see its intended use statement, my full design history files, all of my inputs, outputs, verifications, validations, all integrated into one really nice viewable managed process within Unifize core chat function is another feature that I think truly differentiates it from any other solution out there.

03:11 - 03:43
You know a full history not only of the checklist, but also of any internal conversation from the chat feature. We are doing the DHR review with Unifize, where we do an assembly of all of the records from our ERP into our DHR record. If a device were say to fail collaboration and investigate customer feedbacks, we're able to look back at our records and say, was there anything that happened during the manufacturing of this lot?

03:43 - 04:08
And that's something that was really novel with Unifize, is being able to build a calibration and maintenance management system. A lot of other solution providers don't have that as a offering. Quality is your life. And like you're managing a quality management system, you're in it every single day. You need to be able to really appreciate the system. It is accessible to multiple parties across the organization, both internal and external.

04:08 - 04:40
I have the ability to integrate all of the appropriate party members for the creation of a particular record, be it incoming inspection or a customer feedback, and so that so it completely eliminated all of our, needs of of hallway conversations, ad-hoc meetings, team chats, emails, Unifize really has been a easy system, like even to the point where our sales staff previously had never been in our prior QMS.

04:40 - 05:14
And it was, "hey, we're implementing this QMS. Here's your access log in and here's some trainings", they were able to generate customer feedbacks very intuitively. It is a very intuitive system. All of those administrative tasks are eliminated with our implementation of Unifize that we're able to do all of our preventative maintenance tasks and scheduling in Unifize, manage the status of those assets, perform the calibrations, upload the results of those calibrations.

05:14 - 05:28
Being able to have visibility to in the manufacturing process to say, when we're building this, here are the pieces of equipment used. And with a single click, being able to look at the history for that asset has been a huge boon for our company.