SOP for Disaster management for Chromatographic Software Data System in pharma

SOP for Disaster management for Chromatographic Software Data System

Purpose:

This procedure establishes a disaster management plan for handling any natural disaster or a human-made disaster that destroys hardware, software, or data related to chromatography software.

Scope: 

This SOP applies to all backup devices, including hardware, software, and site backup.

Responsibility:

IT Admin/ Designee: Responsible for ensuring disaster management at respective sites is in place.

Accountability:

IT Admin/ Designee: Is responsible for ensuring that this process is implemented.

Abbreviations:

  1. QC: Quality Control
  2. SOP: Standard Operating Procedure
  3. IT: Information Technology
  4. CSDS: Chromatography Software Data System
  5. RAID: Redundant Array of Independent Disk
  6. WAN: Wide Area Network
  7. HOD: Head of The Department
  8. Dept. : Department

Definition: 

Disaster Management:  Disaster management is the discipline of dealing with and avoiding both natural and man-made disasters. To neutralize or lessen the impact of a disaster, involves preparation, response, and recovery.

Procedure:

Disaster recovery plan for CSDS server in case of hardware failure:

  1. Data should be buffered locally on workstations in case CSDS database server failure occurs, and transferred to the CSDS database server as soon as possible when it comes live.
  2. Hardware disks of the CSDS database server must be protected via RAID levels to ensure the high availability of the server and to avoid data corruption.
  3. There should be a redundant power supply for the server.
  4. There should be daily backups at the site and replication of those backups at an off-site location.
  5. In case of recovery, full backups should be performed daily to avoid dependence on previous backups.
  6. To avoid technical errors and human error on tape backups, tapeless backup solutions should be used.
  7. In case of failure of any network switch, a spare network switch must be available. Also, a network failure protection protocol should be in place through which data should be buffered on local workstations in case of a network failure.
  8. A redundant UPS system should be in place, which could prevent an unexpected shutdown of the database server in case of a power failure.
  9. There should be a performance monitoring SOP and preventive maintenance SOP in place for servers and associated components.
  10. Onsite backup devices are located in different locations from the CSDS database servers within the site.
  11. A contract with the server vendor must be in place with 24×7 support.

Disaster Recovery plan in case of server operating system failure, application failure, and database failure:

  1. At the site, software media for reinstallation should be readily available.
  2. There should be a daily full backup on-site and a replica of the same off-site.
  3. Contracts must be in place with software vendors.
  4. An SOP must be in place for data backup.

A disaster recovery plan in case one of the primary domain controllers fails:

  1. There should be one additional domain controller on each site to fulfill the role of the primary controller.
  2. A contract with the server hardware vendor must be in place.
  3. There should be a performance monitoring SOP and preventive maintenance SOP in place.
  4. There should be a daily full backup on-site and a replica of the same off-site.

Disaster recovery plan for site-level backup failure:

  1. There should be an off-site backup solution in place.
  2. Data must be available on a server that is protected by hardware RAID.
  3. There should be a performance monitoring SOP and preventive maintenance SOP in place.
  4. An additional WAN link should be available in case the primary WAN link fails.

Disaster recovery plan in case of disaster:

It is recommended to have an off-site backup in case of disaster.

Annexures:

None.

References:

None.

 

disaster-management-cycle

 

Also Read:

Difference Between 21 CFR Part 11 and EU Annex 11

What is ICH Q10 in Pharma

Interview Question and Answer

Karl Fischer Titration Q&A

Interview Q&A for Quality Control Analyst

Refer YT channel: Pharmabeej

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