Raw data is defined as "any laboratory worksheets, records, memorandum, notes that are the result of original observations and activities and are necessary for the reconstruction and evaluation of-the report of that study."
also look out for other definitions of raw data in data integrity guidances.,
DATA:-
MHRA - Information derived or obtained from raw data (e.g.a reported analytical result) Data must be:
A - attributable to the person generating the data
L – legible and permanent
C – contemporaneous
O – original record (or ‘true copy’)
A – accurate
WHO:
data - Data means all original records and certified true copies of original records, including source data and meta data and all subsequent transformations and reports of this data, which are 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 where by information related to GxP activities is recorded.
Metadata :-
FDA :-
Metadata is 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.
Among other things, metadata for a particular piece of data could include a date/timestamp for when the data were acquired, a user ID of the person who conducted the test or analysis that generated the data, the instrument ID used to acquire the data, audit trails, etc.
MHRA :-
Metadata is data that describe the attributes of other data, and provide
s 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.
Example: data
3.5 and metadata, giving context and meaning, are:
sodium chloride batch1234, 3.5mg. J Smith 01/07/14
Metadata forms an integral part of the original record. Without metadata, the data has no meaning.
WHO :-
Metadata are data about data that provide the
contextual information required to understand those data. Typically, these are data that describe the structure, data elements, interrelationships and other characteristics of data. They also permit data to be attributable to an individual.
For example, in weighing the number 8 is meaningless without metadata, i.e. the unit, mg. Other examples of metadata may include the time/date stamp of the activity, the operator ID of the person who performed the activity, the instrument ID used, processing parameters, sequence files, audit trails and other data required to understand data and reconstruct activities.
PRIMARY RECORD :-
The record which takes primacy in cases
where data that are collected and retained concurrently by more than one method fail to concur.
In situations
where the same information is recorded concurrently by more than one system, the data owner should define which system generates and retains the primary record, in case of discrepancy.
The ‘primary record’ attribute should be defined in the quality system, and should not be changed on a case by case basis.
Risk management principles should be used to ensure that the
assigned ‘primary record’ provides the greatest accuracy, completeness, content and meaning.
For instance,
it is not appropriate for low-resolution or static (printed/manual) data to be designated as a primary record in preference to high resolution or dynamic (electronic) data. All data should be considered when performing a risk based investigation into data anomalies (e.g.out of specification results)
ORIGINAL RECORD :-
MHRA :-
Original record: Data as the file or format in which it was originally generated, preserving the integrity (accuracy, completeness, content and meaning) of the record, e.g. original paper record of manual observation, or electronic raw data file from a computerized system.
True Copy: An exact
verified copy of an original record. Data may be static (e.g. a ‘fixed’ record such as paper or pdf) or dynamic (e.g. an electronic record which the user/reviewer can interact with).
Example1: a group of still images (photographs – the static ‘paper copy’ example) may not provide the full content and meaning of the same event as are recorded moving image (video – the dynamic ‘electronic record’ example).
Example2: Once printed or converted to static .pdfs, chromatography records lose the capability of being reprocessed and do not enable more detailed viewing of baselines or any hidden fields.
By comparison, the same dynamic electronic records in database format provides the ability to track, trend, and query data, allowing the reviewer (with proper access permissions) to reprocess,view hidden fields,and expand the baseline to view the integration more clearly.
Original records and true copies must preserve the integrity (accuracy, completeness, content and meaning) of the record. Exact (true) copies of original records maybe retained in place of the original record (e.g.scan of a paper record), provided that a documented system is in place to verify and record the integrity of the copy.
It is conceivable for raw data generated by electronic means to be retained in an acceptable paper or pdf format, where it can be justified that a static record maintains the integrity of the original data. However, the data retention process must be shown to include verified copies of all raw data, metadata, relevant audit trail and result files, software/system configuration settings specific to each analytical run*, and all data processing runs (including methods and audit trails) necessary for reconstruction of a given raw data set. It would also require a documented means to verify that the printed records were an accurate representation. This approach is likely to be onerous in its administration to enable a GMP compliant record.
Many electronic records are important to retain in their dynamic (electronic) format, to enable interaction with the data. Data must be retained in a dynamic form where this is critical to its integrity or later verification. This should be justified based on risk.
*computerized system configuration settings should be defined, tested, ‘locked’ and protected from unauthorized access as part of computer system validation. Only those variable settings which relate to an analytical run would be considered as electronic raw data.
its interesting through about the relevance of raw data definition with the original post on risk-assessment of dissolution instrument.
https://ncs-conference.org/download...400_1530_bayesian_approaches/2_Coppenolle.pdf
Dissolution Method Development for Fixed-Dose Combination Drug Products – Challenges and Strategies
https://www.fda.gov/downloads/Drugs/Guidances/UCM456594.pdf
The idea is to cover the activities related to development - validation vs the qualification and operation of the equipment.
