Regulatory Open Forum

Is it acceptable to leave non-required (non-mandatory) fields blank on electronic docs/records? If yes, do you have an example rationale for this?

Would something like this be acceptable - for example:

All required fields (fields marked as mandatory by the validated system/application) on electronic docs/records must be populated.
Fields deemed optional (fields not marked as mandatory within the system/application) may be left blank as these are for additional information only.

------------------------------
Ajit Basrur
Worcester MA
United States
------------------------------

Hello,

especially for the US (FDA) field can not be left empty.
There reasoning for that is if you leave fields empty that it is not clear if those are not applicable or were forgotten to be filled in.

Moreover they even request if fields are not applicable that an argumentation is given for the NA




------------------------------
Franky Dubois
QA/RA Manager
Gent
Belgium
------------------------------

Original Message:
Sent: 05-Jan-2023 18:22
From: Ajit Basrur
Subject: Electronic Records - leave non-mandatory fields blank?

Is it acceptable to leave non-required (non-mandatory) fields blank on electronic docs/records? If yes, do you have an example rationale for this?

Would something like this be acceptable - for example:

All required fields (fields marked as mandatory by the validated system/application) on electronic docs/records must be populated.
Fields deemed optional (fields not marked as mandatory within the system/application) may be left blank as these are for additional information only.

------------------------------
Ajit Basrur
Worcester MA
United States
------------------------------

Good day Ajit,

The expectation is the fields have information contained in them because just like on hard copy forms, if left "blank" then was there supposed to be something there or not?  I have seen this as a significant challenge with electronic records because it is much easier to leave information out/blank than complete - whereas on a hard copy form/record it is easier to see.  When I see this at companies I recommend a couple advice, the first being really question if the electronic system needs all of the fields which are there.  If there are fields which are never used then either remove them from the system or write in the procedure/work instruction that the field is not used.  This can be challenging if using an Off The Shelf (OTS) application because the company may not have the choice to remove or edit fields.  Again, if something is not used that make this clear in the procedure/work instruction so as to show a reviewer or auditor.  The second comment is either pre-populate the field with something such as "N/A" or force the user to put something in the field before they can save/close the record.  This might again be a challenge with OTS electronic systems, but at least if there is a requirement to complete a field before saving or closing the record, this can help prevent electronic records from having the "blanks" which can lead to issues during an audit.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 06-Jan-2023 02:51
From: Franky Dubois
Subject: Electronic Records - leave non-mandatory fields blank?

Hello,

especially for the US (FDA) field can not be left empty.
There reasoning for that is if you leave fields empty that it is not clear if those are not applicable or were forgotten to be filled in.

Moreover they even request if fields are not applicable that an argumentation is given for the NA




------------------------------
Franky Dubois
QA/RA Manager
Gent
Belgium

Original Message:
Sent: 05-Jan-2023 18:22
From: Ajit Basrur
Subject: Electronic Records - leave non-mandatory fields blank?

Is it acceptable to leave non-required (non-mandatory) fields blank on electronic docs/records? If yes, do you have an example rationale for this?

Would something like this be acceptable - for example:

All required fields (fields marked as mandatory by the validated system/application) on electronic docs/records must be populated.
Fields deemed optional (fields not marked as mandatory within the system/application) may be left blank as these are for additional information only.

------------------------------
Ajit Basrur
Worcester MA
United States
------------------------------

Thanks Richard. Yes, we are facing this in an Off The Shelf (OTS) software and I am on the same page to proceduralize the fields that would not be used.  


------------------------------
Ajit Basrur
Worcester MA
United States
------------------------------

Original Message:
Sent: 06-Jan-2023 07:02
From: Richard Vincins
Subject: Electronic Records - leave non-mandatory fields blank?

Good day Ajit,

The expectation is the fields have information contained in them because just like on hard copy forms, if left "blank" then was there supposed to be something there or not?  I have seen this as a significant challenge with electronic records because it is much easier to leave information out/blank than complete - whereas on a hard copy form/record it is easier to see.  When I see this at companies I recommend a couple advice, the first being really question if the electronic system needs all of the fields which are there.  If there are fields which are never used then either remove them from the system or write in the procedure/work instruction that the field is not used.  This can be challenging if using an Off The Shelf (OTS) application because the company may not have the choice to remove or edit fields.  Again, if something is not used that make this clear in the procedure/work instruction so as to show a reviewer or auditor.  The second comment is either pre-populate the field with something such as "N/A" or force the user to put something in the field before they can save/close the record.  This might again be a challenge with OTS electronic systems, but at least if there is a requirement to complete a field before saving or closing the record, this can help prevent electronic records from having the "blanks" which can lead to issues during an audit.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 06-Jan-2023 02:51
From: Franky Dubois
Subject: Electronic Records - leave non-mandatory fields blank?

Hello,

especially for the US (FDA) field can not be left empty.
There reasoning for that is if you leave fields empty that it is not clear if those are not applicable or were forgotten to be filled in.

Moreover they even request if fields are not applicable that an argumentation is given for the NA




------------------------------
Franky Dubois
QA/RA Manager
Gent
Belgium

Original Message:
Sent: 05-Jan-2023 18:22
From: Ajit Basrur
Subject: Electronic Records - leave non-mandatory fields blank?

Is it acceptable to leave non-required (non-mandatory) fields blank on electronic docs/records? If yes, do you have an example rationale for this?

Would something like this be acceptable - for example:

All required fields (fields marked as mandatory by the validated system/application) on electronic docs/records must be populated.
Fields deemed optional (fields not marked as mandatory within the system/application) may be left blank as these are for additional information only.

------------------------------
Ajit Basrur
Worcester MA
United States
------------------------------

Hi Ajit.

As others have stated I recommend never leaving any field on any form, screen, database, etc. blank.  At a minimum it implies that the information was carelessly completed by the user.  At worst, it means that someone didn't even consider (or worse - chose not to enter) the necessary information that should be entered in the field.  This is one reason I always want to have some level of control over what is enterable in the system.

As Richard noted, sometimes with OTS programs it is hard to "mandate" that all fields must have something in them before saving/closing/updating the record.  I like the idea Richard provides for explicitly stating that a particular field is not used by the company and therefore should be left blank in the system.  However, if anyone ever does "find a use" or "find a need" for entering anything into that field (even mistakenly) then you have several issues because now you have a non-conformance with your SOP/work instruction for data entry and you have a field with potentially unknown numbers of records that are now left blank historically that come into question about whether the same information entered once should have been entered every time.

And remember - even "N/A" doesn't specify whether the information is not applicable or not available - these are two very different things to the agencies and auditors because something being not applicable means that there is no reason to enter information because the information would not be useful to the end reviewer; not available means that for whatever reason information is now missing that was not originally documented in the system or investigation or whatever you are filling in.  Make sure you define which of these is the case or even choose to use "N/Av" for not available and "N/Ap" for not applicable so that you can easily explain what you have in the document or system.

------------------------------
Victor Mencarelli MS
Global Director Regulatory Affairs
New YorkNY
United States
------------------------------

Original Message:
Sent: 05-Jan-2023 18:22
From: Ajit Basrur
Subject: Electronic Records - leave non-mandatory fields blank?

Is it acceptable to leave non-required (non-mandatory) fields blank on electronic docs/records? If yes, do you have an example rationale for this?

Would something like this be acceptable - for example:

All required fields (fields marked as mandatory by the validated system/application) on electronic docs/records must be populated.
Fields deemed optional (fields not marked as mandatory within the system/application) may be left blank as these are for additional information only.

------------------------------
Ajit Basrur
Worcester MA
United States
------------------------------

Thanks Victor. Great points on the N/Av and N/Ap!

------------------------------
Ajit Basrur
Worcester MA
United States
------------------------------

Original Message:
Sent: 06-Jan-2023 10:10
From: Victor Mencarelli
Subject: Electronic Records - leave non-mandatory fields blank?

Hi Ajit.

As others have stated I recommend never leaving any field on any form, screen, database, etc. blank.  At a minimum it implies that the information was carelessly completed by the user.  At worst, it means that someone didn't even consider (or worse - chose not to enter) the necessary information that should be entered in the field.  This is one reason I always want to have some level of control over what is enterable in the system.

As Richard noted, sometimes with OTS programs it is hard to "mandate" that all fields must have something in them before saving/closing/updating the record.  I like the idea Richard provides for explicitly stating that a particular field is not used by the company and therefore should be left blank in the system.  However, if anyone ever does "find a use" or "find a need" for entering anything into that field (even mistakenly) then you have several issues because now you have a non-conformance with your SOP/work instruction for data entry and you have a field with potentially unknown numbers of records that are now left blank historically that come into question about whether the same information entered once should have been entered every time.

And remember - even "N/A" doesn't specify whether the information is not applicable or not available - these are two very different things to the agencies and auditors because something being not applicable means that there is no reason to enter information because the information would not be useful to the end reviewer; not available means that for whatever reason information is now missing that was not originally documented in the system or investigation or whatever you are filling in.  Make sure you define which of these is the case or even choose to use "N/Av" for not available and "N/Ap" for not applicable so that you can easily explain what you have in the document or system.

------------------------------
Victor Mencarelli MS
Global Director Regulatory Affairs
New YorkNY
United States

Original Message:
Sent: 05-Jan-2023 18:22
From: Ajit Basrur
Subject: Electronic Records - leave non-mandatory fields blank?

Is it acceptable to leave non-required (non-mandatory) fields blank on electronic docs/records? If yes, do you have an example rationale for this?

Would something like this be acceptable - for example:

All required fields (fields marked as mandatory by the validated system/application) on electronic docs/records must be populated.
Fields deemed optional (fields not marked as mandatory within the system/application) may be left blank as these are for additional information only.

------------------------------
Ajit Basrur
Worcester MA
United States
------------------------------