Regulatory Open Forum

I have an issue concerning how companies capture the "reason for change" in their electronic audit trail. Would you recommend listing the reason for every data field change by having it systematically default to set values (i.e., the system is aware and can auto-populate values such as "Initial Entry," "Updated Data," or "Wrong Data")? In addition, would you require specific comments in addition to the aforementioned "reason for change" values in your system?

Hello Nancy,

Creating the "reason for change" in an audit trail can be trick because having a default auto-populated entry can be viewed as not providing sufficient information.  Though it really depends on the field and what is being changed, because indeed there can be some default selections people choose based on changes being made.  As the examples you provided, entries like Updated Data or Correction Data could be used but again depends on the field.  When I have worked with systems providing audit trails, it would be beneficial to include a reason, but sometimes the application also keeps track of Before, After, Who, Date, and Time, which is often a good approach as well.

I have an issue concerning how companies capture the "reason for change" in their electronic audit trail. Would you recommend listing the reason for every data field change by having it systematically default to set values (i.e., the system is aware and can auto-populate values such as "Initial Entry," "Updated Data," or "Wrong Data")? In addition, would you require specific comments in addition to the aforementioned "reason for change" values in your system?

I have an issue concerning how companies capture the "reason for change" in their electronic audit trail. Would you recommend listing the reason for every data field change by having it systematically default to set values (i.e., the system is aware and can auto-populate values such as "Initial Entry," "Updated Data," or "Wrong Data")? In addition, would you require specific comments in addition to the aforementioned "reason for change" values in your system?

Hi Nancy.

My preference for these sorts of things is to not use pre-populated fields for this information especially in regard to audits of any record that could be considered official or within the purview of the FDA to look at during an inspection.  In fact, whenever I have specified systems to be used for electronic data capture in any company I have ever worked for I have been explicit that I think pre-populated fields or drop-down lists are the worst option for this.

Reason is simple - as Richard notes several of the software systems out there in common use today capture the basic information for the audit - before, after, when and who.  So that is already being captured (or should be captured as a minimum if the system offers audit trail capability).  Therefore the only thing missing is the why.  In this case, use of simple "pithy" or "standardized" comments may actually create more questions or confusion than having the person be required to enter an explanation for why they are changing the previously captured data.  For example, think of an HPLC chromatogram.  If for instance I entered the wrong lot number for the standard (or worse for the product!) into the system and only noticed it after the system ran the full analysis and the file was saved, if the analyst goes back and changes the data then the question arises as to why.  If you simply have "wrong lot" or "wrong information entered" the next question becomes why was it incorrectly entered and is the information on the chromatogram actually attributable to the sample now listed as the lot.  I would far prefer that the user enter something more substantial such as "incorrectly entered the sample lot number instead of the standard lot number" since this is far more likely to be fully understood and it provides the data necessary for any potential retraining exercise that might be deemed necessary for the analyst.

I have an issue concerning how companies capture the "reason for change" in their electronic audit trail. Would you recommend listing the reason for every data field change by having it systematically default to set values (i.e., the system is aware and can auto-populate values such as "Initial Entry," "Updated Data," or "Wrong Data")? In addition, would you require specific comments in addition to the aforementioned "reason for change" values in your system?