The term “accurate” means that data is correct, truthful, valid and reliable.

The criterion of accurate and complete copies of records is that the copy of the record conveys all the information and revisions in the original electronic records, including audit trails and metadata.

Metadata

Metadata summarizes basic information about data, which can make finding and working with particular instances of data easier.

For example:

• Author
• Date created
• Date modified
• File size

These are all examples of very basic document metadata.

Audit Trails

Audit trails are required for all systems that record GxP data.

Audit trails should be generated independently of the operator and include the local date and time of the actions that alter the record.

They cannot overwrite the old data, and they must be stored as long as the record itself is stored.