00:00 - 00:20
if you're watching this and you're on the fence on what quality system you need to get highly, first of all, recommend it. And this is the reasons why it's very easy to implement. It's literally one of the easiest systems I've ever had to implement. And I've been there. I've been to Documentum and all the big other companies out there, the MasterControls, I've been they have implemented some of those systems.

00:20 - 00:29
I have never found a company that was so easy to implement. Then this company specifically, it was very intuitive, lots of support.

00:29 - 00:43
We had maybe two or three calls and we were off running. We had access to the system almost instantaneous based on our initial discussion, that is unprecedented. Most companies take way much longer than that, but we were pretty in good shape, very short time.

00:43 - 00:58
The second reason why I think this is a no brainer for me is the simplicity of it. Most other companies will. It's very hard. You go through courses, they have master courses on being certified in managing information. Why would you do that?

00:58 - 01:10
You don't need to be certified to manage a quality system that is counterproductive. Now you're spending resources on managing training so that you can manage a system that to me doesn't make sense.

01:10 - 01:24
And of course, the last thing it’s compliant. The system is compliant. And we checked it and we looked at all possibilities. It passes the sniff test, the predicate rule test, 21 CFR part 11. It's a validated system.

01:24 - 01:37
Your data is not getting lost. It's not going anywhere. There's a lot of back up, there is security involved in the system. If you have security, you have simplicity and it's easy to implement. I don't see why you couldn't use it.

01:37 - 01:55
I don't know what else you're looking for. My name is Denis, I'm a Quality Systems expert, if you can call it that way. Background is in chemistry, So I'm a scientist by application.

01:55 - 02:04
I went to schools, Iowa State, I was a vice president for quality assurance and regulatory affairs for Harmonic Bionics out in Austin. For that organization, what I did is all things quality related to making decisions based on what information needed to be kept as part of our regulations.

02:17 - 02:34
I think the main thing there, the companies or other tools that are out there they're missing, is separating the conversation from the data. A lot of other systems have a conversational piece which is email and everything else. Then you have the data which is totally isolated.

02:34 - 02:47
So for you to navigate that, you have to know the system and where the data is located. Then you have to go and navigate where the message is, which means you have to channel through thousands of emails to try and get the right information that is a lot of time wasted there.

02:47 - 03:06
What if and this is why it's just a beautiful tool to have why can’t this be done together? There's nothing say in the regs that you can't do this, right? So this tool allows for that to happen together, and that's the power of the tool. When you merge the data and the conversation, you have a full picture of the data.

03:06 - 03:24
Now you can do something about the data. Now, you can talk about the data now everybody's vision, everybody's concern, everybody's opinion of that data is all documented. And the beauty of it is you can search on that data, you can do data aggregations on different conversations, and you can find the latest information.

03:24 - 03:41
One of the best things that I noticed is how easy it is to get audits, preparations through that I'm able to see the conversations, which means I'm able to know what the latest information is, and that is invaluable. Instead of going through emails, all that information is there right, with the data.

03:45 - 04:03
When you're talking about speed to market, you know, return on investment and speed to market, you have to look at the effort. It's going to take you to put the quality system in place. Are you going to go and have a person who is going to know every nuance about your configuration?

04:03 - 04:20
Because that's what it takes for most other companies. You will need to know all of the workflows in detail to know exactly where they are, touch points, on what level of security you expect for each of them. You're also going to need an IT component of it because most of the systems will need a local client of some IT support.

04:20 - 04:41
You're also going to a need level of access. Cost is also a consideration that you need to have. Are you going to have cost that is going to support that? Most of the systems are high cost, high maintenance. When you look at those front end costs and configuration efforts that you need to put, it drives the cost of the final product.

04:41 - 04:59
Now you're going to still be compliant, but you spent a lot of energy doing that. On the other hand, you have Unifize, which of the box, without a lot of configuration, you can still get the level of compliance that you need. Now, you don't need IT to be involved. You leave the configuration of the system with QA.

04:59 - 05:12
Now you've changed the responsibility, it's no longer IT getting in the middle of it, but you have now QA driving it. Who would you rather have? You'd rather have QA driving it than have IT involved in it? Because that's another component you have no control over.

05:12 - 05:26
The best way and we had this experience with Unifize was to have QA drive and once QA drove it, it was easy for QA to make the adjustments without necessarily getting somebody else to do the configuration.

05:26 - 05:51
Somebody has to update somebody else to go the back and forth is really system that we, I have used in the past involved going back to the customer and having a project manager that managed all the changes. So, QA would go into an isolation, they would make recommendations. They would have a meeting, that meeting would drive a decision which would go into the configuration team.

05:51 - 06:11
Then the configuration team would have another discussion about the changes are asking before the changes can be made. So if I'm a Lean Six Sigma person or somebody who just wants to get there directly, I'm cutting to the chase. I'm giving the tool directly to the QA organization who are making and are responsible for the data.

06:11 - 06:18
I would rather have the right people configure the system than have others involved who may not have a stake in the system.

06:18 - 06:37
In terms of time to market, those two systems may get you there, but one is going to get you there faster because it goes directly For us it took four weeks for the other systems that I've worked with. It took us almost a year. Part of that is because the decision makers sometimes when not available, they took a vacation.

06:37 - 06:58
Sometimes the project managers scheduled calls decisions were not made during those calls. So those decisions were punted forward. Sometimes the configuration did not work. That meant they had to go back and reassess those meetings and circles and cycles that you go through are taking time while Unifize comes out of the box, has everything that you need.

06:58 - 07:10
QA was in control of it. They are showing you how to do it. Access is provided and everybody can use it. As soon as everyone is in the system. It's no brainer.