I have been working in medical device environment for a few years now
after working for a number of years in pharma. I see a lot of
differences in opinion with regard to expectations on software
validation. I’d love to open up a discussion with those that work in
either or both of these industries.
The basic premise of the discussion is…
- What kinds of differences in approach for software validation
are being taken between medical device and pharma. (please note I would
like to limit the discussion to “non-product” software)
For starters, here are a few of my observations…
Pharma has been at software validation for a long time and have a lot of
lessons learned. In some cases, best practices have been incorporated
into procedures and these have been shared throughout the industry.
Once practices get to be common, people start to assume that they are
required by the regulators, when in fact they are not explicitly
required. This does not take away from the fact that these are good
processes and help to deliver not only compliance, but QUALITY.
Medical Device on the other hand is a newer industry, relative to
pharma. So people are still on a learning curve… between learning
how to be compliant and learning what makes the most sense with regard
to QUALITY. Medical Devices make software as a product and are subject
to design controls. Because of this, medical device industry is
developing a different philosophy on software quality than pharma. It
is influenced by the idea of verification and validation, with
validation being only one phase of product development. This is very
different than the idea of a validation covering the entire system
lifecycle, as is supported by GAMP for example.
Last observation is with regard to the industry to keep software validation for
non-product software SIMPLE. Some folks take this as license to deliver
the minimum. I take it to mean we are trying to convince people
that software validation is not that bad, and it is only slightly
incremental to what you should be doing as part of good software
So now that I have been long winded and overly philosophical, I am very
interested to hear others thoughts!