Module 12 2019

Implications of transition from paper to electronic Compliance of archiving of electronic records no different to paper requirements but different procedures

• Secured – designated archive area within a system or migrated into a dedicated archive repository • Metadata/electronic signatures need to be maintained along with records • Access limited to designated individuals Electronic Records should be archived in such a way to ensure their reliability, integrity and usability at all times

The Organisation for Professionals in Regulatory Affairs