All record data must be legible (readable) and permanent.

Human-Readable Format

Electronic metadata must also be stored in a human-readable format to support original electronic data.

Readable records are a component of data being complete throughout the data lifecycle, which is another ALCOA + requirement.

No Ambiguity

There should be no ambiguity regarding the clarity of the data.

A record that cannot be read or understood has no value and might as well not exist.

For example:

• Good Documentation Practices (GDP) will always promote the use of indelible ink when completing records
• When making corrections to a paper record, ensure a single line is used to strike out the old record. This ensures the record is still legible
• Controlling your paper records/forms and formatting them such that there is ample room for the information to be recorded
• Corrections to electronic records must show the previous results, who changed the results along with a date and time stamp

To summarize data must be:

• Traceable
• Permanent
• Readable
• Understandable by anyone reviewing the record

This is expanded to include any metadata pertaining to the record.

According to the 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. 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 documenting 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, material status data, the material identification number, and audit trails.”

Contemporaneous
Next, let’s talk about what is meant by “contemporaneous.”

Click on the course below to learn more about contemporaneous.