Hello! we bouth a UV VIS device. What should the documents look like? Design Qualification, operational Qualification. I am really new in the field. Does anyone have an example for which device, UV VIS or HPLC or…for more orientation.?
Thank you very much
Anna
- Draft or update risk assessment of your analytical process.
- Draft or update user requirements specifications (URS) to document what you want the equipment to be able to do.
- DQ: verify using the equipment specifications if the proposed equipment meets the requirements in the URS. URS+DQ are to be done prior to purchase.
- Installation qualification (IQ): to ensure the equipment is installed properly and if you have everything (all parts, cables, user guide, CE certification etc.)
- Operational qualification (OQ): to ensure the equipment functions as the manufacturer intended. (so according to specifications)
- IQ/OQ is often performed by or purchased from the supplier, be sure to review the protocol before execution and add any aspects of your URS that are relevant.
- Performance qualification (PQ): to ensure that the equipment is able to run your tests. What tests to performs is based on your risk assessment. Be sure that all aspects of your URS are addressed.
- Draft validation summary report: summarize all activities above, including deviations and CAPA if necessary. Conclude with release statement (can the equipment be used by QC and for what)
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Thank you very very much dear Claudia!