To lay down the procedure for backup, archive and retrieve the electronic data generated in the quality control department.
1.0 PURPOSE:
1.1 To lay down the procedure for backup, archive and retrieve the electronic data generated in the quality control department.
2.0 SCOPE:
2.1 This SOP is applicable for quality control department.
3.0 RESPONSIBILITY:
3.1 Executive – QC
4.0 ACCOUNTABILITY:
4.1 Manager – QC
5.0 PROCEDURE:
5.1 The chromatographic data generated in the lab shall be archived.
5.2 Only designated or authorized personnel shall do the archiving activity.
5.3 The archival process shall be done as per the operating soft ware.
5.3.1 Millennium32 server connected system:
5.3.1.1 Hot backup (online backup) shall be done on daily basis.
5.3.1.2 To perform Hot back up, click on icon located on server desktop or select (D:MillenniumScript hotbackup.bat).
5.3.1.3 Backup process initializes and continues until the backup is complete. Do not close the window while backup is in progress.
5.3.1.4 Archiving shall be done from a data folder to backup folder every Monday and Thursday.
5.3.2 Workstations / Stand alone systems:
5.3.2.1 Archiving shall be done from a data folder to a backup folder
of different drive every Monday and Thursday.
5.4 Archiving from the backup to an external recording device shall be done once in month.
5.5 Archiving shall be done in duplicate, the second copy should be used as standby in case the first is lost or damaged.
5.6 External recording devices may be compact discs, microfiche etc.,
5.7 Once the archival is complete, check shall be made by the quality control manger to evaluate the retrieval of data for each system.
5.8 After satisfactory retrieval, the archived data shall be deleted from the hard disks, if required.
5.9 Archives of all quality control data for a month shall be stored in duplicate CD’s.
5.10 The archives number shall be numbered as below.
AN-MM – YYYY-CC/NN/TT
Where, AN = Archive number
MM = Month of archiving
YYYY = Year of archiving
CC = Copy no.
NN = serial number of the CD archived
Typical example: AN-05-2004-01/01
5.11 All the archives shall be preserved in closed cabinets away from the QC premises at two different restricted areas.
5.12 A log shall be maintained for the issue and return of archives whenever retrieved as per. Annexure-I and Annexure-II.
5.13 Whenever an archieve document is issued,before retrieving any data, an anti virus program shall be run on the machine and the archive document.
Electronic data, microfiche, restricted, cabinets, machine, duplicate cd
