do all software packages start life as GAMP5 programs?
No GAMP 5 was only released 6 months ago
Validated to GAMP 4 to what extent, GAMP 4 & 5 are guidelines, does this company have it’s own Quality System when it comes to developing software that would be my first question. I have recently audited a software company that had a very poor quality system for the software development side of things. This has to be in place before you even think about the validation aspect.
I dont understand, do you mean that they can provide you with a start-up validation pack of this system.
Validation from your end will include training, SOP’s, Internal Controls.
No company can provide a fully validated system! Be careful.
my query is:
the software may be configurable off the shelf and used in numerous companies today so it is true to say it’s a GAMP4 product now.
but when i ask for the development life documentation of the software package should the documentation reflect a GAMP5 level program?
Not at all true to say that it is a GAMP 4 product, there is no such thing.
The SDLC may reflect a GAMP program but this needs to be documented in the vendors Quality Management System as to the level of compliance they are adhereing to.
Be very careful with your audit, have it prepared well before hand and ask the hard questions.
Hope this helps