Controlled Blank Forms
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Blank templates — logbook pages, worksheets, work-order forms — that are formally issued under document control: numbered or otherwise uniquely tracked, reconciled after use, and never freely photocopied, so that every blank in circulation is accounted for and undocumented or duplicate recording of an activity cannot go undetected.
Uncontrolled blank forms are a classic data integrity finding: if any operator can photocopy a blank logbook page or worksheet and fill it in later, there is nothing to stop a result being recorded away from the point of activity, discarded if unfavourable, and replaced with a cleaner-looking version.
Controlled blank forms close that gap by treating the blank itself as a controlled document — each copy is issued from a master, individually numbered or otherwise traceable, logged out to a named user, and reconciled back in (used, voided, or destroyed under record) so the total issued always matches the total accounted for.
The same control extends to templates generated by a computerized system: a form should not be reprintable an unlimited number of times without record, and any reissue or void of a controlled form should itself be documented with a reason.
- —Blank forms are issued, numbered or tracked, and reconciled after use
- —Prevents unrecorded or duplicate recording of an activity away from the point of use
- —Photocopying or freely reprinting blank forms is a recognised data integrity risk
- —Applies to computer-generated forms and templates, not only paper originals
MHRA GXP Data Integrity Guidance (2018); PIC/S PI 041-1
Frequently asked questions
What is Controlled Blank Forms?
Blank templates — logbook pages, worksheets, work-order forms — that are formally issued under document control: numbered or otherwise uniquely tracked, reconciled after use, and never freely photocopied, so that every blank in circulation is accounted for and undocumented or duplicate recording of an activity cannot go undetected.
Which regulations cover Controlled Blank Forms?
MHRA GXP Data Integrity Guidance (2018); PIC/S PI 041-1