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auditor ★ India, 2012-08-22 14:12 (4663 d 17:10 ago) Posting: # 9090 Views: 2,864 |
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Hi, there is an instrument which was used for analysing the samples of submission studies. As there was no study available to be performed in this particular instrument in near future, management is decided to remove the instrument from the CRO and is planing to install it in different department where it can used further. Can anybody suggest us the answer for following concerns
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Ohlbe ★★★ France, 2012-08-22 16:36 (4663 d 14:46 ago) @ auditor Posting: # 9092 Views: 2,275 |
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Dear Auditor, Only the raw data are to be kept for a certain period of time, which depends on the country the data will be submitted to. There is no obligation to keep the instruments for 15 years... ❝ what is the impact on submitted studies considering that we are having soft copy data on the system as well as in archive No impact, as long as you keep all raw data. If you shift the computer to another department in the company, make sure they keep the soft copy of the data - but you're supposed to have them backed-up and archived anyway. Also make sure you have a full back-up of all data: for instance if you're using Analyst, this should include the instrument audit trail, not just the results table and project audit trails. ❝ Whether regulatory body is going to accept it if they come for inspection Yes, as long as you document what you have done and can prove that you did have that instrument in the company at that time. ❝ is it mandatory to be kept the instrument till the inspection is over. No. ❝ with what precaution/ documentation we can shift the instrument. Precautions: ask the vendor  Documentation: document when it was shifted, from where, to where. Keep, or make sure you will be able to access, all documents on qualification, maintenance, use, etc. Regards Ohlbe — Regards Ohlbe |
Ing. Helmut Schütz