What is “data integrity”?
For
the purposes of this guidance, data integrity 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).
What is “metadata”?
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. For
example, the number “23” is meaningless without metadata, such as an indication
of the unit “mg.” Among other things, metadata for a particular piece of data
could include a date/time stamp 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.
Data
should be maintained throughout the record’s retention period with all associated
metadata required to reconstruct the CGMP activity (e.g., §§ 211.188 and
211.194). The relationships between data and their metadata should be preserved
in a secure and traceable manner.
What is an “audit trail”?
For
purposes of this guidance, audit trail means a secure, computer-generated, time-stamped
electronic record that allows for reconstruction of the course of events
relating to the creation, modification, or deletion of an electronic record.
An audit trail is a chronology of
the “who, what, when, and why” of a record.
For
example, the audit trail for a high performance liquid chromatography (HPLC) run
could include the user name, date/time of the run, the integration parameters used,
and details of a reprocessing, if any, including change justification for the reprocessing.
Electronic audit trails include those that track creation, modification, or
deletion of data (such as processing parameters and results) and those that
track actions at the record or system level (such as attempts to access the
system or rename or delete a file). CGMP-compliant record-keeping practices
prevent data from being lost or obscured (see §§ 211.160(a), 211.194, and
212.110(b)). Electronic record-keeping systems, which include audit trails, can
fulfill these CGMP requirements.
How does FDA use the terms “static”
and “dynamic” as they relate to record formats?
For
the purposes of this guidance, static is used to indicate a fixed-data document
such as a paper record or an electronic image, and dynamic means that the
record format allows interaction between the user and the record content. For
example, a dynamic chromatographic record may allow the user to change the
baseline and reprocess chromatographic data so that the resulting peaks may appear
smaller or larger. It also may allow the user to modify formulas or entries in
a spreadsheet used to compute test results or other information such as
calculated yield.
How does FDA use the term “backup”
in § 211.68(b)?
FDA
uses the term backup in § 211.68(b) to refer to a true copy of the original data
that is maintained securely throughout the records retention period (for example,
§ 211.180). The backup file should contain the data (which includes associated
metadata) and should be in the original format or in a format compatible with
the original format.
This
should not be confused with backup copies that may be created during normal
computer use and temporarily maintained for disaster recovery (e.g., in case of
a computer crash or other interruption). Such temporary backup copies would not
satisfy the requirement in § 211.68(b) to maintain a backup file of data.
What are the “systems” in “computer
or related systems” in § 211.68?
The
American National Standards Institute (ANSI) defines systems as 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).
Source: FDA Guidance for Industry
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