How to display electronic data when audit by officer

Jude1991

Registered
Hello everyone, I'd like to find some idea about how to provide the English data in SAP when NMPA audit. Our SAP system was validated with English. So when we show data in SAP, that would be English...... I'm wondering is that acceptable? Meanwhile I'm going to have a work instruction to describe how to display the electronic data in audit, such as printout then write the Chinese when require. Is anyone have experience about this?
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Welcome Jude1991!

I would certainly think your showing your SAP data in your native language would be acceptable. As an auditor, when I go to a place where different languages are used I must either use that language myself or the client provides an interpreter. The latter adds time to the audit.

Can you contact the people who would be doing the NMPA audit and ask how they would handle it?
 

ChrisM

Quite Involved in Discussions
I've had to manage an audit by an overseas Authority. One of the conditions of the audit was that we provided an interpreter competent in the technical terminology of the industry we were in. Of course the authority fully understood that as an English company operating in England, all our records, MRP/ERP information etc would be in English - hence the need for an interpreter. You shouldn't need a work instruction for this, particularly if it is only required during external audits
 

Jude1991

Registered
Welcome Jude1991!

I would certainly think your showing your SAP data in your native language would be acceptable. As an auditor, when I go to a place where different languages are used I must either use that language myself or the client provides an interpreter. The latter adds time to the audit.

Can you contact the people who would be doing the NMPA audit and ask how they would handle it?
We're an American company located in China, and gonna have a ChinaFDA(NMPA) audit, so we are worry about the language due to our system are all in English. We got information from consultant that NMPA auditor would like to read Chinese.
 
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