-- 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. (www.inea.com) 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 HStimpson@StimpsonCommunications.com David A. Vogel Intertech 781-255-5420 dav@inea.com