Hi
Does anyone use Clarity v7.4 in a GLP regulated environment? I have quite a number of questions around how you process and report the data generated and would be interested to know your processes.
Thanks
Jennifer
Clarity in GLP lab
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JaroslavKana
- Posts: 10
- Joined: Mon Mar 13, 2017 8:37 am
Re: Clarity in GLP lab
Dear Jennifer,
here is a list of countries where we have a confirmed usage of Clarity in companies which are audited by various (local and international auditing authorities)
Bulgaria – 1 company
Hungary – 6 companies (some of the local branches of international pharmaceutical companies with regular FDA audits - Clarity passed these audits)
Germany – 1 company
Italy – 6 companies (at least one of them is audited regularly by FDA)
Unfortunately we don’t have authorization to provide their contact details.
Best Regards
Jaroslav
here is a list of countries where we have a confirmed usage of Clarity in companies which are audited by various (local and international auditing authorities)
Bulgaria – 1 company
Hungary – 6 companies (some of the local branches of international pharmaceutical companies with regular FDA audits - Clarity passed these audits)
Germany – 1 company
Italy – 6 companies (at least one of them is audited regularly by FDA)
Unfortunately we don’t have authorization to provide their contact details.
Best Regards
Jaroslav
Jaroslav Kana
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marcojfelix
- Posts: 18
- Joined: Thu Mar 29, 2012 8:32 pm
Re: Clarity in GLP lab
Hi Jennifer,
We are a contract Lab in Brazil under ISO17025, most of our systems runs with Clarity 7.2 and they are all validated following FDA CFR21Part11 and GAMP5. We have received several audits during the last years and Clarity passed all security and tracebility requirements for computer systems.
Audit trail, user access control and privileges, protected data files and folders under Windows and backup/restore processes are possible when you configure both GLPs parameters under Clarity sw and Windows OS.
We are a contract Lab in Brazil under ISO17025, most of our systems runs with Clarity 7.2 and they are all validated following FDA CFR21Part11 and GAMP5. We have received several audits during the last years and Clarity passed all security and tracebility requirements for computer systems.
Audit trail, user access control and privileges, protected data files and folders under Windows and backup/restore processes are possible when you configure both GLPs parameters under Clarity sw and Windows OS.
Marco Felix
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marcojfelix
- Posts: 18
- Joined: Thu Mar 29, 2012 8:32 pm
Re: Clarity in GLP lab
Hi Jennifer,
We are a contract Lab in Brazil under ISO17025, most of our systems runs with Clarity 7.2 and they are all validated following FDA CFR21Part11 and GAMP5. We have received several audits during the last years and Clarity passed all security and tracebility requirements for computer systems.
Audit trail, user access control and privileges, protected data files and folders under Windows and backup/restore processes are possible when you configure both GLPs parameters under Clarity sw and Windows OS.
We are a contract Lab in Brazil under ISO17025, most of our systems runs with Clarity 7.2 and they are all validated following FDA CFR21Part11 and GAMP5. We have received several audits during the last years and Clarity passed all security and tracebility requirements for computer systems.
Audit trail, user access control and privileges, protected data files and folders under Windows and backup/restore processes are possible when you configure both GLPs parameters under Clarity sw and Windows OS.
Marco Felix
