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 1st 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.
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