GDocP

Good Documentation Practice

GDocP is the everyday mechanics of making records trustworthy. Entries are made at the time the activity happens, in indelible ink, by the person who performed the work, signed or initialled and dated. Corrections use a single line through the original so it stays readable, with the correction, the initials, the date, and — where the change is not self-explanatory — the reason. Nothing is obliterated, overwritten, or pencilled in for later.

The rules exist because of what they prevent. Blank fields invite later completion; "ditto" marks and unexplained gaps make a record ambiguous; pre-dating or back-dating destroys the contemporaneous quality that makes the record evidence at all. Transcribing results from a scrap of paper onto the official form breaks Original — the scrap was the raw data, and it has now been discarded.

The same principles carry into electronic systems, where they become configuration rather than handwriting: unique user accounts so entries are attributable, controlled system clocks so timestamps mean something, mandatory-field enforcement so records cannot be left incomplete, and audit trails so changes remain visible. In hybrid environments the hardest question is which record is the original — and the answer must be defined, not assumed.

• —Contemporaneous, attributable, indelible — recorded as it happens, by the person who did it.
• —Corrections: single line through, original still legible, plus initials, date, and reason where needed.
• —No blanks, no obliteration, no back-dating, no pencil, no transcription from scrap paper.
• —If it is not recorded, it did not happen — the record is the evidence, not the memory.
• —Electronic equivalents: unique accounts, controlled clocks, mandatory fields, audit trails.
• —In hybrid paper/electronic systems, define which record is the original — do not leave it ambiguous.

EU GMP Part I Chapter 4 (Documentation); 21 CFR 211.68, 211.100, 211.188 and 211.194; MHRA GXP Data Integrity Definitions and Guidance for Industry (2018); PIC/S PI 041-1; WHO TRS 1033 Annex 4; ALCOA+ as the underlying attribute set.