F
Frank Haberbosch
We (medical device manufacturer) use (many years) a software to administrate inspection equipment.
This software has no audittrail. furthermore there is no possibility to login.
The question is:
Is it possible to use and validate this software?
Do we have to replace the software by a part 11 compliant software?
What possibilities do we have?
This software has no audittrail. furthermore there is no possibility to login.
The question is:
Is it possible to use and validate this software?
Do we have to replace the software by a part 11 compliant software?
What possibilities do we have?
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