00:00 - 00:25
Because we're in a regulated environment. As I’ve mentioned, we have doc control and we have to have reviewers, approvers, digital signatures in 21 CFR Part 11 compliance, which is the regulations that applies to digital documentation and signatures. What we started with was, literally a pen and paper quality system. So like, word documents that you'd print out and somebody would be signing pen on paper when, let's say a part comes in, it needs to be inspected.

00:25 - 00:49
It was very tedious. There was no way of tracing the documentation when it was generated. There was no way to link anything. The digital signature and approval workflows streamline my lot release on finished goods as I mentioned, because before that was email back and forth. Now, my quality supervisor uploads the test, uploads the CoA clicks a button says, ‘Alright, I'm done.’ And it goes right to the customer, because, by selecting the customer at the beginning, it automatically knows who that's going to go to.

00:49 - 01:01
That's one end where they go too far. And then there are those who make changes. And then you don't know when or where or how or who or what. There's a lot of changes that happen in those files, and it's always good to see the history of that file.

01:01 - 01:29
Who accessed it? When it was updated? What was updated? What is the latest file? And, then I have a time, a date, a when, a where, a who, an approval and that chain of command and custody and responsibility and accountability, is effortless. The ability to link different quality system activities together helps tell the story of our product as it's being made. Unifize does a very good job of actually tracking all those elements.

01:29 - 01:42
If I have questions, I ask it in the environment prior to signing. I don't have to go find people. I don’t have to call people. I don't have meetings. I don't have to have emails. With Unifize I can say, ‘Okay, I need this to be from a group of product development’. Create a group with all those users in it.

01:42 - 02:01
I need somebody from product development to sign. Here's who I worked with. But I can also have these other people who, can look at the conversations and look at everything in Unifize and understand what's going on. I'm actually asking, ‘Hey, wait! What about this aspect before I sign?’ And then once I'm comfortable, I get comfortable signing through the collaboration.

02:01 - 02:24
You know, we looked at several other systems and primarily we looked at, what modules were available. Were they able to handle change control? Were they able to handle, you know for example, 21 CFR Part 11. So electronic signatures, you know, that cut out a few options that we had originally looked at because we needed something that was compliant to electronic signatures.

02:24 - 02:45
That's where Unifize stood out. The system is compliant. And we checked it and we looked at all possibilities. It passes the sniff test. The predicate rule test. With 21 CFR Part 11. It's a validated system. And so, everyone is involved in it. It takes your email burden off. The return on investment is really compliance at the end of it.

02:46 - 03:08
Are you able to be compliant? Are you able to answer the questions regarding your data? Are you able to access the right records in the right format? Are you able to defend the information that you have? If you're able to answer those questions to the regulators, that shows that your company is in control. And the regulations require that you show control Unifize provides you with that ability.

03:08 - 03:15
So, if you're looking for something simple, no overhead, I think it’s a no brainer. It's something that you should probably consider.