Dear Sirs,
I was assigned for preparing protocol and template of computer system validation for HPLC and TOC but I do not know where can I start. Any one can share me a protocol and template examples for these. Thanks you very much
Hi phucto,
I can guide you from where you can start.
For preparing protocol for HPLC and TOC, I would like to know, if these are the COTS systems or just they upgrade the system?
If these are COTS System , than DO you have any Vendor Testing Documents?
Do you have user manual of the system?
If these are not COTS System , than Do you have any previous version’s Documents? Like Previous version’s VP, RS, IOQ, VSR, RTM?
Let me know the above question’s answer, I will definitely guide you In what way you can generate the protocols for HPLC and TOC.
HPLC typically utilizes different types of stationary phases contained in columns, a pump that moves the mobile phase and sample components through the column, and a detector capable of providing characteristic retention times for the sample components and area counts reflecting the amount of each analyte passing through the detector. The detector may also provide additional information related to the analyte.