Archiving

Archiving is the process of protecting records from the ability to be further altered or deleted and storing these records under the control of dedicated data management personnel throughout the required records retention period. Archiving is a formal process of taking a record off-line it to a different location disabling it from any further changes.

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.

Data integrity

Ensuring data integrity at the pharmaceutical business is an important task. Data integrity is the sum total of arrangements which ensuring that data, irrespective of the process, format or technology in which it is generated, recorded, processed, retained, retrieved and used will ensure a complete, consistent and accurate record throughout the data lifecycle.