How to Complete a GxP Record by Hand
Make a paper entry that will still be defensible years after the person who made it left.
What a how-to is not
A how-to is SPEQ’s practitioner method, not a procedure. It does not replace your own SOP, it is not a validated approach, and the judgement calls in it belong to your quality unit.
Handwritten records remain the largest surface area for data integrity findings, because every entry is an individual act with no system enforcing it. The expectations are unglamorous and unchanging: record at the time, in indelible ink, attributably, on the approved form, leaving nothing blank. Almost every finding in this area is one of those five, and none of them is difficult — they are simply easy to skip when the room is busy.
- 1
Record at the time the activity happens
Contemporaneous means as the observation is made, not at the end of the shift from memory or from a scrap of paper. Transcription from an informal note creates an unofficial original that either becomes raw data nobody controls or is destroyed, and both outcomes are findings.
- 2
Use the approved, issued form
Entries go on the current controlled version, issued through the controlled process. A personal copy printed months ago may be a superseded version, and work recorded on it may have followed instructions that no longer apply.
- 3
Write so it stays legible and permanent
Indelible ink, legible to someone else, in the language the procedure specifies. Pencil, erasable ink and correction fluid are all disqualifying, and legibility is judged by a reader who was not there rather than by the author.
- 4
Sign and date so the entry is attributable
The signature identifies the individual, and dates follow the specified format so that a date cannot be read two ways. Initials only work where a specimen signature list ties them to a person and is maintained.
- 5
Leave nothing blank
A field that does not apply is marked so, dated and initialled. A blank cannot be distinguished afterwards from an omission, and it also leaves room for something to be added later by someone else.
- 6
Have the record reviewed by someone who checks it
A second person reviews for completeness and correctness against what should have happened. A review signature applied without reading is worse than no review, because it converts an unchecked record into one that appears verified.
- !Entries transcribed at end of shift from an informal note, creating an uncontrolled original.
- !A locally printed form used after the controlled version was revised.
- !Blank fields left rather than marked not applicable, so omission and non-applicability are indistinguishable.
- !Review signatures applied without reading, which makes an unchecked record look verified.
How to Complete a GxP Record by Hand: frequently asked questions
Common questions on complete a gxp record by hand.
What is wrong with writing it up at the end of the shift?
It is not contemporaneous, and it creates an intermediate record. Either the scrap of paper is the original — in which case it is raw data being kept outside the system — or it is destroyed, which is destruction of an original record. There is no version of this that survives scrutiny.
Why does a blank field matter so much?
Because it is ambiguous in a way nothing else in the record is. Nobody can later distinguish "this did not apply" from "we forgot", and the space remains available for an entry made by someone else at another time. Marking it not applicable removes both problems in one stroke.
Can initials be used instead of a full signature?
Yes, where a maintained specimen signature list ties each set of initials to a named individual over a defined period. Without that list the initials identify nobody, and every entry bearing them is unattributable — which undermines the record rather than merely abbreviating it.