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?
This Title 21 CFR Part 11 Guide is unlike books you're used to. If you're looking for a textbook, this might not be for you. This book and its included digital components is for you who understands the importance of asking great questions. This gives you the questions to uncover the Title 21 CFR Part 11 challenges you're facing and generate better solutions to solve those problems.
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Unless you're talking a one-time, single-use project, there should be a process. That process needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?'
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In using the questions you will be better able to:
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Your purchase includes access to the Title 21 CFR Part 11 self-assessment digital components which gives you your dynamically prioritized projects-ready tool that enables you to define, show and lead your organization exactly with what's important.