Original Record (MHRA)
The first or source capture of data or information, e.g., original paper record of manual observation or electronic raw data file from a computerised system, and all subsequent data required to fully reconstruct the conduct of the GXP activity. Original records can be static or dynamic.(TR80)
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Hybrid Approach (WHO)
The use of a computerized system in which there is a combination of original electronic records and paper records that comprise the total record set that should be reviewed and retained.(TR80)
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Corruption (Data) (FFIEC)
Errors in computer data that occur during writing, reading, storage, transmission, or processing, which introduce unintended changes to the original data.(TR80)
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True Copy (WHO)
A true copy is a copy of an original recording of data that has been verified and certified to confirm it is an exact and complete copy that preserves the entire content and meaning of the original record including, in the case of electronic data, all essential metadata and the original record format as appropriate.(TR80)(TR84)
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True Copy (FDA)
21 CFR 211.180(d) requires records to be retained "either as original records or true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records". Electronic copies can be used as true copies of paper or electronic records, provided the copies preserve the content and meaning of the original or raw data, which includes associated metadata and the static or dynamic nature of the original records.(TR80)(TR84)
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True Copy (MHRA)
A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure as the original.(TR80)(TR84)
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Systems (in computer or related systems) (WHO)
A computerized system collectively controls the performance of one or more automated processes and/or functions. It includes computer hardware, software, peripheral devices, networks and documentation, e.g., manuals and standard operating procedures, as well as the personnel interfacing with the hardware and software, e.g., users and information technology support personnel.(TR80)
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Systems (in computer or related systems) (FDA, attributed to ANSI)
People, machines, and methods organized to accomplish a set of specific functions. Computer or related systems can refer to computer hardware, software, peripheral devices, networks, cloud infrastructure, operators, and associated documents(e.g., user manuals and standard operating procedures).(TR80)
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Static Record Format (WHO)
A static record format, such as a paper or pdf record, is one that is fixed and allows little or no interaction between the user and the record content (TR80)
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Static Record Format (MHRA)
A "fixed" record such as paper or pdf. (TR80)
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Static Record Format (FDA)
A fixed-data document such as a paper record or an electronic image.(TR80)
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Raw Data (MHRA)
The original record (data) which can be described as the first-capture of information, whether recorded on paper or electronically. Information that is originally captured in a dynamic state should remain available in that state.(TR80)
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Raw Data (FDA)
Any laboratory worksheets, records, memoranda, notes, or exact copies thereof that are the result of original observations and activities of a nonclinical laboratory study and are necessary for the reconstruction and evaluation of the report of that study. Raw data may include photographs, microfilm or microfiche copies, computer printouts, magnetic media, including dictated observations, and recorded data from automated instruments.(TR80)
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Metadata (WHO)
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.(TR80)
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Metadata (MHRA)
Metadata is data that describe the attributes of other data and provide context and meaning. Typically, these are data that describe the structure, data elements, inter-relationships and other characteristics of data. It also permits data to be attributable to an individual (or if automatically generated, to the original data source).(TR80)
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Metadata (FDA)
The contextual information required to understand data. A data value is by itself meaningless without additional information about the data. Metadata is often described as data about data. Metadata is structured information that describes, explains, or otherwise makes it easier to retrieve, use, or manage data.(TR80)
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Peak Intergration
Process used to by a chromatographic system to determine the peak area (based on height and width) and obtain the quantitation of the peak of interest. The measurement is based on the integral technique of splitting the peak into a large number of rectangles, which are then summed to provide an estimate of the total area under the peak. (TR80)
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CGMP Record (FDA)
When generated to satisfy a CGMP requirement, all data become a CGMP record. You must document, or save, the data at the time of performance to create a record in compliance with CGMP requirements, including, but not limited to, §§ 211.100(b) and 211.160(a). FDA expects processes to be designed so that quality data is created and maintained and cannot be modified. (TR80)
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Complete Data (FDA)
FDA requires complete data in laboratory records, which includes raw data, graphs, charts, and spectra from laboratory instruments and associated metadata. (§§ 211.194(a) and 212.60(g)(3) (2). A complete record of all data secured in the course of each test, including date and time the test was conducted and all graphs, charts, and spectra from laboratory instrumentation, properly identified to show the specific component, drug product container, closure, in-process material, or drug product, and lot tested. (TR80)
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Dynamic Record Format (MHRA)
An electronic record which the user reviewer can interact with.(TR80)
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Data (WHO)
Data means all original records and true copies of original records, including source data and metadata and all subsequent transformations and reports of this 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.(TR80)
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Dynamic Record Format (FDA)
The record format allows interaction between the user and the record content.(TR80)
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Data Integrity (FDA)
Refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).(TR80) (TR84)
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Data Integrity (WHO)
The degree to which data are complete, consistent, accurate, trustworthy and reliable and that these characteristics of the data are maintained throughout the data life cycle. 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.(TR80) (TR84)
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Data Integrity (MHRA)
The degree to which data are complete, consistent, accurate, trustworthy, reliable and that these characteristics of the data are maintained throughout the data life cycle. The data should be collected and maintained in a secure manner, so 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.(TR80) (TR84)
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Data Lifecycle (MHRA)
All phases in the life of the data (including raw data) from initial generation and recording through processing (including transformation or migration), use, data retention, archive/retrieval and destruction.(TR80) (TR84)
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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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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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Archival (MHRA )
A designated secure area or facility (e.g., cabinet, room, building or computerised system) for the long-term retention of data and metadata for the purposes of verification of the process or activity.(TR80)
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Human Factors
A science discipline that examines human psychological, social, physical, and biological characteristics to evaluate the design, operation, or use of products or systems for optimizing human performance, health, safety, and/or habitability. [Synonym: Ergonomics] (TR62)(TR80)
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