Cerner Quality System AOK with FDA

COMPANY: Cerner Corp.
PURPOSE: To document software, processes and procedures during the Software Development Life Cycle (SDLC).

APPLICATION: Cerner Quality System -- Cerner Corp., Kansas City, Mo., a developer of software for hospitals and large health care organizations, must adhere to Food and Drug Administration (FDA) regulations, which require extensive design and documentation controls.

"We've spent a lot of time and money in the past creating post-development documentation at the request of FDA inspectors," said Douglas Darbyshire, quality systems engineer at Cerner. "Because of our regulatory responsibilities we have to be able to provide documentation of our software processes and procedures on demand," he explained. To bring down documentation costs, Cerner implemented the Cerner Quality System, providing design control documentation throughout the Software Development Life Cycle (SDLC).

The Cerner Quality System is built around a central repository that contains all the processes for producing output used and created during the SDLC. Paradigm Plus from Platinum Technology, Oakbrook Terrace, Ill., provides the repository for analysis and design and development objects so documentation is available.

"Not all of the Cerner products must adhere to FDA regulations, so with this particular project we are focusing on those that do require regulation," said Darbyshire. "We need to file for FDA clearance on all of our regulated products before we can market or begin selling them.

"We were able to determine mid-project that we were on the right road. Documentation that used to take two years can now be done in six to nine months. We should be able to file for FDA clearance sooner."

Paradigm Plus provides Cerner designers and developers with the ability to create pictures and describe application objects.

All knowledge objects created during the SDLC are stored in the Paradigm Plus object oriented database. An internal scripting language is then used to generate formal requirements and design specifications in HTML from the knowledge objects.

"Paradigm Plus allows us to build our model, generate HTML pages from it, and then communicate that information via the Web," said Darbyshire. "We can take the diagrams into images and descriptions of the objects, and we can see it all together."

This allows Cerner to perform online design reviews and see what has been specified for the project. The company has also achieved a higher rate of reusability because designs can be reused with slight modifications. "We can almost re-step an engineer through the entire process," said Darbyshire.

A formal SDLC methodology was employed as well. Cerner began with Rumbaugh OMT and is currently transitioning to the Unified Modeling Language (UML). To assure total compliance, the company must be able to map the appropriate methods and techniques back to the FDA's Quality System Regulations.

According to Darbyshire, it is important to have this repeatable, documentable process in place. "We need this to meet our FDA requirements, so that we can show our software has been safely created and that we can safely manage changes."

Cerner is pleased with the results of the project. "We've seen the cost savings, and the work is not as labor-intensive," Darbyshire said. Platinum's Paradigm Plus has met all of the company's expectations. According to Darbyshire, the product is the best they have seen on the market. "It met the requirements of where we needed to be right now. While it's hard to say if this product, or any product, will keep up with our needs, there's nothing out there right now as good as Paradigm Plus.

"If I had the project to do over again, I would do it pretty much the same," Darbyshire added.

- Deborah Melewski


DOUGLAS E. DARBYSHIRE, quality systems engineer

TOM HANF, team leader, components

TONY NEVINS, programmer analyst

MARCOS GARCIA, programmer analyst

TOM GIFFORD, programmer analyst

LISA GRAYSON, product team leader

TERESA DAVIS, product team leader

Saves time and cost in producing documentation required by the FDA as part of Cerner's regulatory responsibilities.

Paradigm Plus, from Platinum Technology; and Active Server Pages using both Visual Basic from Microsoft and JavaScript.