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Signing Data

Signing of data is a feature of RF500 required for compliance to the electronic signature section of 21 CFR Part 11.

From the persepctive of 21 CFR Part 11 the definition of an electronic signature is as follows:

12.2.2. Electronic Signature

A computer data compilation of any symbol or series of symbols, executed, adopted or authorized by an individual to be legally binding equivalent of the individual's handwritten signature.

Signed data as far as the FDA is concerned means that the signer accepts that the data is true and good, and thet he is taking legal responsibility for it. It is no different to printing off the page and signing it with a pen. It can be deemed as legally binding as shown above.

As far as RF500 is concerned each historic Period of data can be individually signed. A Period cannot be signed if it is still live and capable of storing extra data.


Figure 1 - Find Data to Sign

Use the Drop Down menus for Task and Period on the Transmitter Detail View to find the Historic Period to be signed.

In order to sign a live Period the Period must be closed using either Start / Stop Logging or Tasking the transmitter. Only once it have become historic it is possible to sign the data.

To sign the data, click to bring up the following dialogue:


Figure 2 - Electronic Signature for Data

To sign the data, enter the reason for signing the data and your authority to sign, and click  to Sign and Close or to close without signing.


Each action of Data Signing is recorded in the Audit Trail


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