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Access Database

Does an Access database have to comply with Part 11? It is used to generate a paper report (which has been validated) and is under change control. Regular users do not have access to the database.


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Conduct your risk assessment of the Access application that you are developing and/or using. Determine if the data captured and used falls under Part 11 compliance requirements, i.e. does that data support (directly or indirectly) any regulated process or decision making?

Can you prove or validate that accuracy of the output data through 100% visual verification? Or do you rely on the database to manage your data? The only way to decrease your automation controls (validation, verification or qualifications) is to increase your manual controls (visual verifications, composite or 100% verifications).


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