Shimadzu LCsolution S/W FDA Part 11 Compliant?
Posted: Sat Jan 31, 2015 2:43 am
Dear all,
I am building a FDA compliant lab, and I am working on the procurement of HPLCs. The potential vendors are: Waters, Agilent and Shimadzu. I have to balance the factors, including performance, compliance and cost. Shimadzu is very attractive in terms of cost.
But I do not have hands-on experience on Shimadu LCsolution software, I would like to know your opinion regarding the part 11 compliance problem, i.e., audit trail, privilege, access control, data integrity check...
Thanks,
Terry
I am building a FDA compliant lab, and I am working on the procurement of HPLCs. The potential vendors are: Waters, Agilent and Shimadzu. I have to balance the factors, including performance, compliance and cost. Shimadzu is very attractive in terms of cost.
But I do not have hands-on experience on Shimadu LCsolution software, I would like to know your opinion regarding the part 11 compliance problem, i.e., audit trail, privilege, access control, data integrity check...
Thanks,
Terry