Informational CFR 21 Definition for Data or Raw Data

ChemistAnalytical

Starting to get Involved
#1
Hello,

I'm having trouble finding a definition for data per CFR 21. Specifically in regards to nonclinical studies or cGMP manufacture.

For context, I'm working on a risk assessment of a dissolution instrument.

Best regards,

Chemist
 
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ChemistAnalytical

Starting to get Involved
#2
Found an adequate answer:

Guidance for Industry
Good Laboratory Practices
Questions and Answers
US Dept of Health and Human Services
FDA, ORA 1981
Page 4

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."
 

v9991

Trusted Information Resource
#5
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 provides 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.

http://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.
 

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Marc

Hunkered Down for the Duration
Staff member
Admin
#6
@supadrai - As a lawyer you may not have touched on this before, but probably should have, and probably have but didn't think of it in this way. Law documents are much the same.
I really like this definition, one could build an entire course around it.
Not to detract from @v9991 's post above, but the above definitions go back many years. I learned them in college in chemistry and biology (we called them Good Laboratory Practices, even though Wikipedia says GLP was introduced in the US in 1978: Good laboratory practice) in the early 1970's, and in aerospace the same applied when I worked in that field in the 1980's, and in automotive when I was involved in anti-lock brake and air restraint system design & development.

Historically, this goes back to the seventeenth century, at least: Scientific method

While some things have changed, such as computers, not much has changed over the years with the exception, to some degree, of what is defined as metadata.

@v9991 - Thanks for the above as it brings a great amount of detail applicable to data in today's world.

EDIT ADD: If you ever watch a complete documentary of the ValuJet Flight 592 investigation, you will see the discovery of falsified data by airline employees. You will see this from time to time. Legally this is fraud. I myself spent 2 days with two DIA (Defense Intelligence Agency) agents around 1986 because someone complained of suspected test data manipulation. Most the tests were outsourced to Wyle test labs. Having followed what we're calling GLPs here, I could show every interconnection, every document (including original data, all outputs such as reports and data analysis). In a way, it was kind of fun. I knew everything was done correctly and it was a bit entertaining as they did the "Good Cop - Bad Cop" routine. I had worked at Sealtron as QPL laboratory manager: Sealtron Completes AS9100 Standard Audit - The complainer did get an FBI and DIA 'raid' on Sealtron, and a lot of whistle blower 'reward' money, but in the end Sealtron was only charged with "...announcing for sale QPL products on a few products which were awaiting official QPL approval papers from the DLA " (US's Defense Logistics Agency). The DIA HAD to do something to save face, so they ended up with a really stupid, expensive charge. In short, sales screwed up. Big whoop...

As an additional 'quickie', read: Piltdown Man - Fraud is fraud.
 
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