This short test is designed to help you check your current workflows, examine potential solutions, and see how Florence complies with Part-11.
Do you currently store and/or manage clinical trial documents electronically? (Email, shared drives, purpose-built tools, etc.)
Have your electronic clinical trial document systems been validated against Part-11 security requirements?
Have your electronic clinical trial document systems been validated for functionality?
Do users require a unique username and password to access your clinical trial documents?
How are you able to control user access to files?
Does your system produce an automated audit trail of all document actions, when those actions took place, and who performed the action?
If a document is changed are you still able to access previous versions?
Does your system include electronic signatures?
If you're using eSignatures does it include the name of the signer, time-stamp, and reason for signing?
If you use eSignatures, does the system require two unique identifiers? (ie: username and password)
If you use eSignatures, does the system require the user to input their password each time they sign a document?
Do you have custom SOPs on file for how you manage electronic clinical trial documents and workflows?
*Note that this analysis is meant as a simple checkup and does not guarantee or suggest FDA Part-11 compliance. The questions and results are taken from FDA Part-11 guidance and regulations.