Hi all.
I'm being asked to supply and install an BMS system for a pharmaceutical facility. I'm told the facility will be validated . I'm aware that my system should comply with GMP & 21CFR Part 11. As I dig further on the subject I realize 21CFR Part 11 concentrates mostly on the security issues of logged data. My question is could someone tell me what is meant by validation and how will my system be validated (I mean this validation issue is totally new to me). My second question is should my hardware be of a special grade? for example Hospital grade? Or do Pharmaceutical grade equipment exist?. If yes How can i show my client that this product is of a grade that complies with GMP? More simply put, what are the requirements of my hardware and software or any other related things to be compliant with GMP and 21CFR Part 11 and get validated.
Would much appreciate if someone could enlighten me. One final word , I would like to add that this project is not in the USA nor in Europe, but it must match those standards
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