Backup and business continuity plan
A backup means a copy of one or more electronic files created as an alternative in case the original data or system are lost or become unusable (for example, in the event of a system crash or corruption of a disk). It is important to note that backup differs from archival in that backup copies of electronic records are typically only temporarily stored for the purposes of disaster recovery and may be periodically overwritten. Such temporary backup copies should not be relied upon as an archival mechanism.Backup and recovery processes must be validated.
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Audit trail
Audit trail. The audit trail is a form of metadata that contains information associated with actions that relate to the creation, modification or deletion of GXP records. An audit trail provides for secure recording of life-cycle details such as creation, additions, deletions or alterations of information in a record, either paper or electronic, without obscuring or overwriting the original record. An audit trail facilitates the reconstruction of the history of such events relating to the record regardless of its medium, including the “who, what, when and why” of the action.Read More
Change control
Change control. The process of assuring that a computerized system remains validated following a change. It includes assessing the impact of the change to determine when and if repetition of a validation or verification process or specific portion of it is necessary and performing appropriate activities to ensure the system remains in a validated state.Read More
Configuration management
Configuration management. A discipline applying technical and administrative direction and surveillance to identify and document the functional and physical characteristics of a configuration item, control changes to those characteristics, record and report change processing and implementation status and verifying compliance with specified requirements.Read More
Data
Data. Data means all original records and true copies of original records, including source data and metadata and all subsequent transformations and reports of these data, which are generated or recorded at the time of the GXP activity and allow full and complete reconstruction and evaluation of the GXP activity. Data should be accurately recorded by permanent means at the time of the activity. Data may be contained in paper records (such as worksheets and logbooks), electronic records and audit trails, photographs, microfilm or microfiche, audio- or video-files or any other media whereby information related to GXP activities is recorded.Read More
Validation of 1C
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Cleaning verification
Cleaning verification is a process gathering of evidence through chemical analysis after each batch/campaign to show that the residues of the previous product or cleaning agents have been reduced below the scientifically set maximum allowable carryover level.Read More