Quality - SOP - Data Security and Disaster Recovery

$350.00 AUD

The process outlined in this document will ensure that your company complies with the relevant clauses of ISO 13485 (6.3), 21 CFR (820), and EU MDR/IVDR.

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Purpose of Document

Your company is reliant on information technology systems to perform day-to-day business activities, and for storage of crucial company information and assets.

A disaster is any sudden, unplanned catastrophic event that could likely cause serious disruption of IT systems and result in an organisation being unable to perform critical business processes. A disaster could be the result of significant damage to a portion of the operations, a total loss of a facility or the inability of your employees to access that facility.

Disasters may include but are not limited to:

  • Physical disasters e.g. flood or fire destroying one or more of the employees’ home offices.
  • Virtual disasters e.g. unintentional shutdown of vital electronic systems, hacking, viral attack, breach of website or system security.

A plan for disaster recovery, back-up and archiving will minimise the impact of potential disasters and will ensure that critical business processes will continue to function if there is a failure of one or more of your company’s information processing or telecommunications resources.

Scope of Document/s

This procedure describes the required activities for back-up and archival of your company’s electronic data and assets. It also outlines the steps to be undertaken for restoration of information technology systems in the event of a disaster.

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