The first key parameter of data integrity is that the data must be “attributable.”

Actual Individual

We need to know who performed the data-generating act, and when it happened.

The data must be attributable to an actual individual.

Clearly Documented

The identity of the person performing the activity as well as their actions and the date/time must be clearly documented.

This could be recorded manually by signing or initialling and dating a paper record, or by a validated computer system in an audit trail.

Signature Log

To ensure paper records are attributable (specifically for signatures) it is important to ensure a signature log is maintained in order to be able to identify initials, signatures, or aliases of individuals performing and documenting actions.

Fully Validated

To ensure computer records/date are attributable it’s important to ensure the system is fully validated and that any actions that take place are linked to the individual making them through their e-signature once logged in with their User ID and Password.

Whether you sign electronically or on paper, you should clearly understand the implication of your signature.

You are responsible for the documents you sign.

Specific

A signature should be specific to each individual, and the practice of signing someone else’s name or initials prohibited.

This is fraud and is taken very seriously!

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