IT Synergistics leverages Blueprint Simulation Capabilities to Ensure Compliance

IT Synergistics

“Blueprint has been wonderful for improving quality control. Now developers know what has to happen before writing code, rather than struggling their way through it. That makes a big difference.”

Melinda Bryant, Managing Director

Company Profile

Founded in 2005, IT Synergisitics is a highly specialized organization that unites blood bank industry experts to an efficient and reliable software that manages all aspects of blood donation. IT Synergistics works directly with blood banks to ensure all software needs are met.

 

 

Company

IT Synergistics

Industry

Information Technology
Medical Services

Number of Employees

Medium Enterprise

Location

United States

User Simulation

User Simulation Enabled
Employee Participation
Throughout Product
Development

visualization4

Visually Driven
Requirements Supported Teams
To Ensure Compliance

Traceability and Trackability

Traceability and Trackability
Met FDA Requirements
While Enhancing the
Revision Process

We knew we needed a tool that had simulation capabilities to not only give us insight into how the could user interacts, but also review software enhancements and provide feedback in real-time. This would drastically improve our communication throughout the organization. 

Melinda Bryant, Managing Director

Challenges Faced

Melinda Bryant, Managing Director explains that since the IT Synergistics team is geographically dispersed, the organization is challenged with getting everyone on board. Having a dispersed team there is always potential for breakdown between the development team and the end user implementing the software. 

A critical part of development is meeting stringent regulatory demands. Since LifeTec Elite is classified as a medical device, traceability, trackability and FDA requirements are a mandatory aspect of product development and quality assurance.

Over the years, questions and communications often lacked clarity, which held up approvals and added to development costs. Rewriting and communicating updates we time consuming for everyone - the cost of rework accounted for 15% of the work being done. Version control for requirements was another concern because they were using word documents for document control. 

The client knew they needed a software that had the ability to store all data in a central location, but also can simulate user experience. Since they were bringing on new contractors and are geographically dispersed, these capabilities will strengthen their ability to communicate and enhance software requirements. 

Choosing Blueprint

In seeking a solution, IT Synergistics outlined a number of requirements. First was a system that would meet FDA traceability and trackability requirements, which demand an account of what happened, who did it and when, throughout the revision process.

Because IT Synergistics operates virtually, it was also essential that the requirements solution they chose could provide everyone with simultaneous visibility based on real-time information.

Finally, user simulation was a must for users participating in product development. After fielding several offerings, IT Synergistics selected Blueprint, a visually driven requirements definition and management solution that guides and supports teams through project milestones and processes, including authoring, management, validation, monitoring, collaboration and integration.

IT Synergistics selected Blueprint, a visually driven requirements definition and management solution that addresses all the company’s needs, and ensures it gets requirements right from the start.

Moving Forward

“Today all company employees are using Blueprint software for managing requirements. Version control issues have been eliminated since everyone is always working with the latest and greatest version,” she adds.

Real-time feedback and improved communications has also reduced rework to 5%. “A lot of that is because we can now get things right from the beginning.” IT Synergistics is using Blueprint to manage the latest release of LifeTec Elite, which includes up to 40 different enhancements. “Blueprint has been wonderful for improving quality control. Now developers know what has to happen before writing code, rather than struggling their way through it. That makes a big difference.”

The biggest plus says Bryant is that Blueprint has helped close the loop on requirements. “Blueprint will be an integral part of our development processes going forward. It keeps everyone in synch, from requirements writers and developers to customers and end users. Every user is on point for what needs to be done.”

To learn more about Blueprint, please contact us.

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