What is data integrity? What is metadata? FDA Data Integrity and Compliance With CGMP definations

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).

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Source: FDA Guidance for Industry

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