NEW YORK, NY--(Marketwire - July 9, 2007) - Since the lifecycle of medical device software runs from inception to decommissioning a lifecycle approach to the validation of production and quality-system software works best, Bob Barrett, director of systems engineering at Intertech Engineering Associates, told a seminar at the recent Medical Design & Manufacturing East Exposition and Conference.

He pointed out:

--  The validation process must address documentation and the software for
    as long as the software is used in a production or quality-system process.
--  A phased view of the software permits focused objectives by phase.
--  A common lifecycle should be used to cover both custom-developed and
    off-the-shelf software.
--  A phased approach helps you understand which tasks are necessary.
Validation isn't the same as testing, he said.

"The level of validation depends on the risk, and if the risk is low, you may not need testing beyond installation," Barrett said.

Validation should focus on the intended nature of the process that the software is facilitating. Defining intended uses and requirements before purchasing an off-the-shelf software solution can help both decision and validation processes.

"Testing does not improve safety or performance, it only aides on one's ability to assess assurance," he noted.

Qualification of the proper installation of the software should be performed for all software before operational use. Installation includes verifying any procedural updates and also verifies that related software documentation is added to the software master file. Predefined tests should be run on the software, verifying the requirements and intended use.

You must maintain the software master file throughout the life of the software, including any changes to the software and their re-validation, he said. The record of decommissioning must be documented in the file.

Barrett concluded by covering the lessons learned on testing.

Intended use and functional requirements for the software need to be determined before the tests are developed. But functional requirements of software that are not part of the intended use do not require testing if they are not used. Risk analysis should be completed before testing is developed.

"The validation process is as much a process of understanding and documenting the intended use and evaluating the risk as it is of testing," he said.

If the automated process can impact quality, mitigations, control or avoidance measures, make sure safety-related failures are to be tested for effectiveness. Installation qualification should always be completed.

Intertech Engineering Associates, Inc. ( provides hardware and software development, requirements and quality engineering, product validation services, training and consulting for medical device manufacturers.

Contact Information: Contact: Henry Stimpson Stimpson Communications 508-647-0705 David A. Vogel Intertech 781-255-5420