Disaster Recovery and Solutions for Validated Systems

4 Fundamental Steps of Disaster Recovery

  1. Identifying the incident.
  2. Quarantining the affected systems.
  3. Performing a risk review of potential losses vs. the last “known good” status.
  4. Restoring the system to normal operations.
  • The definition of safety actions needed to protect company data, assets, equipment, and personnel.
  • A concerted focus on deploying technology, implementing equipment, and doing periodic testing in preparation for the recovery of systems after a disaster.
  • The specification of backup and recovery methods and processes that will be implemented, which may include:
  • Offsite recovery (in cases where a lost location must be rebuilt).
  • Lost server room or data center recovery.
  • Lost business-critical operation recovery.

The Impact of Disasters on Validated Systems

Cloud Technology: The Cure for Disaster Recovery Concerns

  • What is your process for recovering files in the event of data loss?
  • In the event of a catastrophe, how much time will it take to get the system operational and data restored to the most recent full backup (i.e., what is the Recovery Point Objective (RPO) and Recovery Time Objective (RTO))? (Note that the fastest RPO that can feasibly be achieved is four hours and the fastest RTO is four hours.)
  • Does the disaster recovery process include electronic file loss, electronic database record loss, data corruption, accidental overwriting of the file system, and facility utility disruption (or other need specific to your business)?
  • Can you provide audit results, certification reports, statements of compliance, or other evidence of your ability to satisfy industry standard regulatory requirements for disaster recovery, data integrity, and validation (e.g., does it meet standards for cloud-specific data integrity and information security controls such as ISO 27017)?
  1. Average cost per hour of enterprise server downtime worldwide in 2019,” Thomas Alsop, Statista, Dec. 7, 2020.



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