Title 21 CFR Part 11 A Complete Guide - 2021 Edition

Are copies of the electronic records comprising the transaction available to all parties?

Does your means for providing electronic signatures be considered objectively reliable?

Have retention periods for the electronic records retained in the system been specified?

How are series access points in multiple formats affected by the provider-neutral model?

How can one prove your organization of an electronic record as of a particular instant?

How does your organization ensure the confidentiality of the information that you provide?

How will records be filed, indexed, and associated to permit easy management and recovery?

Is an electronic records audit trail retrievable throughout the records retention period?

Is simultaneous write access to the same electronic record by multiple users prohibited?

Will you be storing an increasing volume of electronic records and fewer paper records?

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