Assess your compliance with FDA regulations for electronic records and electronic signatures. Identify gaps in your GxP systems before FDA inspection.
Scope: 21 CFR Part 11 applies to records required to be maintained under FDA regulations and to electronic signatures intended to be the equivalent of handwritten signatures.
Are all computerized systems validated to ensure accuracy, reliability, and consistent performance?
Can you generate accurate and complete copies of records in human-readable and electronic form?
Are electronic records protected to enable accurate and ready retrieval throughout the retention period?
Do you maintain secure, computer-generated, time-stamped audit trails for record creation, modification, or deletion?
Do you maintain complete documentation for system operation and maintenance procedures?
Are operational system checks in place to enforce permitted sequencing of steps and events?
Do you have authority checks to ensure only authorized individuals can use the system?
Are there checks in place to determine the validity of data input or operational instructions?
Is each electronic signature unique to one individual and not reused or reassigned?
Do you verify the identity of individuals before establishing, assigning, or certifying electronic signatures?
Are electronic signatures based on at least two distinct components (e.g., ID and password)?
Do you enforce password complexity, expiration, and minimum length requirements?
Are signed electronic records displayed with meaning of signature, date/time, and signed name?
Are electronic signatures linked to their respective records to prevent falsification?
Do you have procedures to prevent unauthorized access to electronic records?
Are controls in place to prevent loss of data due to system failures or environmental factors?
Do you maintain backup copies of electronic records and have a disaster recovery plan?
Are communications that contain electronic signatures encrypted or otherwise secured?
Have all personnel been trained on the requirements of 21 CFR Part 11?
Do you maintain documentation of all Part 11-related training?
Have individuals using electronic signatures certified that their signatures are genuine?
If using both paper and electronic records, are appropriate controls in place to prevent discrepancies?
Please answer all requirements to see your results