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 governance. The totality of arrangements to ensure that data, irrespective of the format in which they are generated, are recorded, processed, retained and used to ensure a complete, consistent and accurate record throughout the data lifecycle.
Data integrity. Data integrity is the degree to which data are complete, consistent, accurate, trustworthy and reliable and that these characteristics of the data are maintained throughout the data lifecycle. The data should be collected and maintained in a secure manner, such that they are attributable, legible, contemporaneously recorded, original or a true copy and accurate. Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices.
Data life cycle. All phases of the process by which data are created, recorded, processed, reviewed, analyzed and reported, transferred, stored and retrieved and monitored until retirement and disposal. There should be a planned approach to assessing, monitoring and managing the data and the risks to those data in a manner commensurate with potential impact on patient safety, product quality and/or the reliability of the decisions made throughout all phases of the data life cycle.
Metadata. Metadata are data about data that provide the contextual information required to understand those data. These include structural and descriptive metadata. Such data describe the structure, data elements, interrelationships and other characteristics of data. They also permit data to be attributable to an individual. Metadata necessary to evaluate the meaning of data should be securely linked to the data and subject to adequate review. For example, in weighing, the number 8 is meaningless without metadata, i.e. the unit, mg. Other examples of metadata include the time/date stamp of an activity, the operator identification (ID) of the person who performed an activity, the instrument ID used, processing parameters, sequence files, audit trails and other data required to understand data and reconstruct activities.
Static record format. A static record format, such as a paper or PDF record, is one that is “fixed” and allows no or very limited interaction between the user and the record content. For example, once printed or converted to static PDFs, chromatography records lose the capability of being reprocessed or enabling more detailed viewing of baselines or any hidden fields.
Dynamic record format. Records in dynamic format, such as electronic records, that allow for an interactive relationship between the user and the record content. For example, electronic records in database formats allow the user to track, trend and query data; chromatography records maintained as electronic records allow the user (with proper access permissions) to reprocess the data and expand the baseline to view the integration more clearly.