Glossary Terms (Simple List)
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Audit Trail (WHO)
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.(TR80)
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Audit Trail Review Assessment (ATRA)
A tool that can be used to help determine what elements within the audit trail should be reviewed, and the frequency at which the review should take place for each part of the audit trail where a review is required.
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Autoclave
A chamber for steam sterilization. (TR45)
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Automated Inspection
Consists of mechanical handling and presentation of product containers combined with automated inspection of the filled containers using image analysis and/or light obscuration. (TR79)
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Back Pressure
Residual pressure opposing the free flow of liquid or gas at the outlet side of the filter. (TR45)
Pressure applied downstream of a filter or other piece of equipment. (TR26)
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Backstop (Finger Plate or Thumb Plate)
Feature that enhances the area to hold the syringe and is usually designed to avoid accidental removal of the plunger from the back. By design, it may also serve as a flange extender to facilitate holding of the syringe during injection. (TR 73)
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Backup (FDA)
A true copy of the original data that is maintained securely throughout the records retention period. The backup file should contain the data (which includes associated metadata) and should be in the original format or in a format compatible with the original format.(TR80)
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Backup (MHRA)
A copy of current (editable) data, metadata and system configuration settings maintained for recovery including disaster recovery.(TR80)
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Backup (WHO)
A copy of one or more electronic files created as an alternative in case the original data or system are lost or become unusable. Backup differs from archival in that back-up copies of electronic records are typically only temporarily stored for the purposes of disaster recovery and may be periodically overwritten. Such temporary back-up copies should not be relied upon as an archival mechanism.(TR80)
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Bacteria
Single-celled, microscopic organisms typically with a cell wall and characteristic shape (e.g., round, rod-like, spiral or filamentous); lacking a defined nucleus (“prokaryotic”). (TR26)