SOP for Computer System Backup and Restore on Server

This document details the procedure for the Computer System Backup and Restore on the Server. It is the policy of XYZ Limited that the written procedure shall be followed for the Computer System Backup and Restore on the Server or backup database SQL server

This procedure is to be applied at the time of Computer System Backup and Restore on Server.

RESPONSIBILITY 

Persons along with their responsibilities and accountability are given: Quality Manager, IT Manager, Vice President-Technical.

PROCEDURE

DEFINITIONS

cGxP: This is a general term that applies to the following agency-regulated areas; Cgmp for current Good Manufacturing Practices, cGLP for current Good Laboratory Practices, and cGCP for current Good Clinical Practices.

System Manager: An individual with responsibility for a specific project or application within Barr Pharmaceuticals, Incorporated. This individual may or may not have a Barr title of Manager.

Server Administrator: An individual who may be a Barr employee or consultant performing server administration or server backup functions on Barr's servers. Responsibilities may include but are not limited to server builds, server monitoring, application of patches, and server backup, restore, or archive functions.

Back-up Logs: Evidence that a backup job or procedure has been successfully completed. This information may be recorded manually, electronically (for example, in an electronic spreadsheet), or generated automatically by a utility or backup application software package. These logs demonstrate success or failure.

Permanent Storage Media: The fixed disk storage on a computer system or storage area network.

Removable Storage Media: Removable storage media may be in the form of a removable disk, cartridge tape, diskette, optical disk, or other storage media that can be removed from the computer system and stored at the same or another location.

Backup: The copying of data from the permanent storage media to the removable storage media or to permanent storage media for an established point in time.

Restore: Rebuilding some or all data on permanent storage media by applying appropriate data from removable and/or permanent storage media to permanent storage media.

Archive: A procedure by which data is moved from the live system to removable and/or permanent storage media. Archived data may be retrieved from storage media as requested.

Daily Backup: This is a backup that is executed on a daily frequency. Daily backups may be executed each workday but may exclude weekend days. The output of this backup presents a point in time copy of the data residing on the online system at the time the backup executed

Weekly Backup: This is an incremental backup during a weekday and a full backup on the weekend. The output of this backup represents a point-in-time copy of the data residing on the online system at the time the backup was executed.

Weekend Backup: This is a full backup that is executed once per week. Weekend backups may be performed on Friday, Saturday, or Sunday. The output of this backup represents a point-in-time copy of the data residing on the online system at the time the backup was executed.

Month-End Backup: "On or about 1^st of each Month": The source of the monthly backup will be a weekend backup tape that is pulled to become the month-end backup. The weekend backup is full. The output of this backup represents a point-in-time copy of the data residing on the online system at the time the backup is executed.

Master Server List: The list of servers maintained by the IT Server Admin Group that includes the server name, classification of priority for backup, information about backup schedule, severity classification for operating system patches, and other information about servers. This information is derived from the REF-802 Server Requirements Form.

Server Requirements Form: Request made to the SAG requesting the purchase or installation of one or more servers which may contain or reference the functional requirements for the application, the intended use of the server, the server's operational criticality, requirements for backup, archive, or replication, classification for backup and severity for patch management purposes.

Server Administrator Responsibilities

Backup Task: Automated or manual daily backups are scheduled for servers as per the Master Server List maintained by the IT Server Admin Group (SAG). Backup is accomplished by performing the following activities:

The Server Administrator or designate will maintain the procedure and the backup schedule for all applicable Application and File Server data where backups are required per the Master Server List.

The Server Administrator or designate will be responsible for creating the backup media sets. The Server Administrator or designate will be responsible for the execution of backups, verifying that backups are completed successfully, and verifying/maintaining the documentation for completed backups. Backup script changes should be made through an IT Change Control and tested appropriately.

If a failed backup is identified upon review of the manual or system-generated backup logs a help desk incident will be created to document the failure. The situation will be assessed to identify the cause of the failure and to determine if immediate action is needed to correct the failure.  If a permanent change to the backup software, process, or schedule is required to correct the failure an IT Change Control should be created.

The backup process must be audited periodically for critical servers as classified in the Master Server List. 

The audit process should consist of (1) verifying the backup procedure in place for the server selected is being followed through the review of backup logs and related electronic or hardcopy documentation; and (2) verifying the backup and restore process (es) for that server. 

Verification steps include that the backup is complete, accessible, and able to be restored within the time frames established in the Master Server List. The Server Administrator or designate is responsible for verifying the accuracy of this test and for logging the test in the "System Operations" binder. 

For any failed audits a help desk incident will be created to document the failure. If it is determined that immediate action is required to correct the failure an IT Change Control will be created to document the activities.

Restore Task: The restore of a file takes place per user's request or whenever the Server Manager or designate deems it necessary to restore the system to a predetermined point in time.

Restoration of files is accomplished by performing the following activities:

The Server Administrator or designate will maintain the restore procedure for all applicable Applications and File Server data for systems or applications where backups are required per the Master Server List.

The computer system users will obtain supervisory-level approval through a PC Form. The PC Form needs to specify the data to be restored.

The Server Administrator will be responsible for performing data restoration using the procedure defined in Step 1.

Archive Task: Archival of any data residing on an active server will require IT Change Control except systems or servers for which a validated archive process has been established, including but not limited to Chromatographic Data Systems. The archived data may be stored on permanent or removable storage media. This archived data may reside on Barr premises. A backup or second copy should also be stored at an off-site Barr or third-party storage facility and may also be located on Barr premises if a copy is also maintained off-site. Exchange Server (e-mail) data will not be archived.

ABBREVIATIONS:

XYZ:   XYZ Limited

 CQA:   Corporate Quality Assurance

SOP:   Standard Operating Procedure

cGLP:   current Good Laboratory Practices

cGCP:   current Good Clinical Practices

 cGMP:   current Good Manufacturing Practices

 IT:   Information Technology

SAG:   Server Admin Group