Module 12 2019

Roles and Responsibilities

Archivist – accountability to ensure records are protected, controlled and managed to maintain integrity and validity and accessible to regulatory authorities when required

IT Staff

• Supporting computer software, hardware and IT infrastructure

Automated regular backups

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Ensuring “chain of custody”

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Systems validation

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• Facilitation of storage and retrieval of records • Access control to archive and archive records • Documented training in how to operate an electronic archive

The Organisation for Professionals in Regulatory Affairs