SafetyDrugs pharmacovigilance system includes an audit trail compliant to CFR Part 11 requirements.

As the US Food and Drug Administration (FDA) 21 CFR Part 11 rules specify what an audit trail needs to do:

• build an audit trail of any data changes that occurs in any ‘significant process’, i.e. those that have a clinical effect
• capture the ‘before’ and the ‘after’ data associated with every change
• ensure that you have a secure, tamper-proof ‘closed system’.

For every significant process (including Login, Print) SafetyDrugs stores the before and the after image in a protected structure, keeping trace of the person, time and workstation from which the data has been processed.

Only System administrator and certified users can access to the information generated by Audit Trail. Moreover, SafetyDrugs includes a Versioning Process, that manages the Clinical Case History. Some critical steps cause the automatic saving of all data concerning the Adverse Event, defining a new Version number and Versioning Time.

Audit Trail can be customized according to customer needs.