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Database file storage.

Posted: Tue Nov 20, 2018 3:58 pm
by FocusTechnical
Hi,
We have had a couple of customers now who have been told that their CDS will need to have database file storage in order to comply with data security.
This has been coming up during site audits in the UK and despite us telling the users that Clarity is GLP/21 CFR Part 11 compliant if the auditors say they need database file storage then the users will only look at this type of data system.
It would be good to have the option in Clarity to use database file storage like Empower/Chromeleon/OpenLab in order to comply with the demands of UK auditors.

Best regards,
Pete.

Re: Database file storage.

Posted: Thu Nov 22, 2018 5:08 pm
by Jaroslav Kana
Dear Pete,
we have pending suggestion for implementation of database file storage. We track such request under our internal tracking ID 'ISS-80395' and I added you as another user request for such feature which may help prioritize this feature to be implemented. This feature is not scheduled to any specific Clarity future version. I agree this might be good tool for specific customers because 'Database' is buzzword regarding pharma industry and chromatography software.
This has been coming up during site audits in the UK and despite us telling the users that Clarity is GLP/21 CFR Part 11 compliant if the auditors say they need database file storage then the users will only look at this type of data system.
It would be good to have the option in Clarity to use database file storage like Empower/Chromeleon/OpenLab in order to comply with the demands of UK auditors.
I agree it might be a topic in UK but only in UK because of this MHRA had quite obvious requirement in this document https://assets.publishing.service.gov.u ... hdrawn.pdf but in was already withdrawn (see item 'File Structure' on page 14).
Final version of this document https://assets.publishing.service.gov.u ... _Final.pdf has been here with us since March and I would understand it this requirement is no more there - see item '6.18 File Structure' on page 19.
Could you be more specific who where those auditors? Where these auditors of MHRA or from any other official UK body? Do you have access to any audit report dealing with requirement for database file storage? If you have such report I would be pleased if you could share this report with me.
I haven't found any document requiring database released by any other significant related body (FDA/EU...) but I might be wrong. In case you have such document I would be pleased if you could share such document with me.

In case you have any further comments do not hesitate to to get in touch with us.

Re: Database file storage.

Posted: Sat Apr 23, 2022 12:12 pm
by jayeshpatel
Clarity should support Fully in 21 CFR environment AEAP like Empower /Chromeleon etc