Backup/restore plan

The following points should he considered in a backup/restore plan ... 

Business Continuity Planning (Disaster Recovery) A disaster recovery plan should be in place to ensure the continued operation of the laboratory in case of an adverse event that renders the instrument out of commission and hence causes interruption to the business processes which the system supports. Adverse events like the failure of the critical hardware components of the instrument and the failure of the application software do happen in the day-to-day operation of a laboratory. The disaster recovery plan should provide the necessary steps to restore the systems back to a functional state. The steps typically include instructions to reinstall the application software to the personal computer controlling the instrument, to reconfigure the instrument, and to restore the backup data to the instrument. 

Prior to software installation, a back-out or roll-back plan and procedure must be documented. If the planned installation fails, the back-out plan is implemented and the restoration activities and results are documented. The back-out plan includes information on performing a backup of the system, and/or making use of an existing backup of the system, which has been verified prior to software installation... 

Prerequisites Validation (Summary) Report X X X X Backup and Restoration, Security, Training, Business Continuity Plans Response to Validation (Master) Plan including Statement... 

Define manual ways of working for application during system outage. Remember that on restoration some reprocessing of data input to the original or backup system (catch up) will be required and this must be planned for. Manual records made during the outage, even once input into the restored system, must be retained. 

Backup and restoration Archive and retrieval Business continuity planning... 

Problem reporting and resolution Software errors and maintenance Backup and recovery of data Archive and restoration of data Maintenance of hardware Disaster recovery (business continuity planning)... 

Disaster recovery is usually forgotten, or not considered, as it will never happen to me. The recovery plan should have several shades of disaster documented. After loss of a disk drive for any reason from simple equipment failure through to the complete loss of the computer room or building due to fire or natural disaster, how will data be restored from tape or backup store and then updated with data not on backup ... 

System operation Change control Backup and restoration System upgrade Contingency plans Service Level Agreements (SLAs)... 

To prevent the loss of critical GxP data, backups of systems should be taken at regular intervals, as documented in local SOPs. This prevents the physical loss of important system data or its accidental deletion by users. A backup also provides a basis from which the application can be restored in the event of an unforeseen event arising that results in the need to invoke the documented Disaster Recovery Plan. Data that should be subject to backup activities includes system software, such as the operating system and any preconfigured software modules, application software, and... 

Configuration management Disaster recovery plans/procedures Vims protection Backup and Restoration Security Management... 

Interface card addressing Wiring checks Draft maintenance procedures (e.g., backup and restoration, security handling. Contingency Plan)... 

System management (e.g., formal contract or SLA, system management documentation, documented responsibilities, overviews of system components, existence of and adherence to change control procedures, backup and restore procedures, physical and logical security, Disaster Recovery Plans)... 

Clear and proper procedures must be in place for using the system (procedures and/or user manual), backup and restoration, periodic evaluation, maintenance and problem management, safety and security, training. Disaster Recovery and Contingency Plans, business continuity, change control, and system retirement. 

The establishment of a quality unit in the IT Department (or in small operations, a person, part of whose responsibility is quality), responsible for not only the GxP aspects of the IT operation but also other quality management procedures in IT, such as data security, access and control procedures, backup, archiving and restore, disaster planning and so on. 

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