I'm looking for suggestions of guidance on how best to plan, execute, and document software validation - for both OTS software we use at our facility, as well as software we develop.
Major consideration is that we are a small company with limited resources, and the requirements/intended-use of all software we use/develop have low risk profiles. For the most part it's pretty simple stuff - excel calculations (maybe some macros), OTS micro-controller flash programming, document storage/retreival...
I'm familiar with the FDA's "Principles of Software Validation" guidance (as it's free), and I've looked at some other threads, where the following suggestions come up:
- GAMP 5 Manual
- ISO/TR 80002-2:2017 (yes, we are a medical device company)
Question: Given our pretty basic needs (uncomplicated/low-risk & OTS software, limited resources), are documents such as GAMP 5 & ISO 80002-2 useful (over-and-above free guidances such as the FDA's)? If so, what do they offer? Have people found these particularly useful for their own practices? Are there any other guidances you'd recommend?
Any feedback/advice much appreciated!
MM
Major consideration is that we are a small company with limited resources, and the requirements/intended-use of all software we use/develop have low risk profiles. For the most part it's pretty simple stuff - excel calculations (maybe some macros), OTS micro-controller flash programming, document storage/retreival...
I'm familiar with the FDA's "Principles of Software Validation" guidance (as it's free), and I've looked at some other threads, where the following suggestions come up:
- GAMP 5 Manual
- ISO/TR 80002-2:2017 (yes, we are a medical device company)
Question: Given our pretty basic needs (uncomplicated/low-risk & OTS software, limited resources), are documents such as GAMP 5 & ISO 80002-2 useful (over-and-above free guidances such as the FDA's)? If so, what do they offer? Have people found these particularly useful for their own practices? Are there any other guidances you'd recommend?
Any feedback/advice much appreciated!
MM