SOPREFERENCE OUTLINE

Good Documentation Practice SOP

Procedure for handwritten GxP records built around the five requirements almost every finding in this area reduces to: contemporaneous, on the issued form, legible and permanent, attributable, nothing blank. Includes a signature register to resolve initials and a review section that distinguishes checking entries from signing them. Maps to WHO TRS 996 Annex 5 and the MHRA GxP data integrity guidance.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

CHECKING ACCESS

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REGULATIONS MAPPED
WHO TRS 996, Annex 5MHRA GxP DI (2018)
DOCUMENT TYPE
SOP
LAST UPDATED
August 2026
PURPOSE

Handwritten records remain the largest surface area for data integrity findings, because every entry is an individual act with no system enforcing it. Almost every finding here reduces to one of five things — contemporaneous, on the issued form, legible and permanent, attributable, nothing left blank — none of them difficult, all of them easy to skip when the room is busy.

What's Inside

✓Scope, roles, approved writing materials, and the point at which a controlled form is issued
✓The five requirements, each stated together with how it actually fails on a busy shift
✓Step-by-step entry procedure covering what is written, at what moment, and by whom
✓Correction convention — single line, initial, date, reason — with the original entry left readable
✓Not-applicable convention, so an omission and a genuine non-applicability stay distinguishable to a later reviewer
✓Signature register resolving initials to people, with active dates including the date someone left
✓Review expectations that distinguish checking the entries from signing to say they were checked

How to Use It

1Record at the time of the action; transcribing at end of shift creates an uncontrolled original that becomes the real record
2Write on the issued controlled form only, because an entry made on a loose sheet has no issuance trail behind it
3Correct with a single line, initial, date and reason, leaving the original entry readable rather than obscured
4Mark every not-applicable field explicitly, so omission and non-applicability remain distinguishable months later at review
5Keep the signature register current including leaving dates — an initial that could belong to two people belongs to neither
6Review by reading; a signature applied without checking makes an unchecked record look verified, which is worse than none
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Purpose and Scope
2The Five Requirements
3Making an Entry
4Signature Register
5Review
REGULATORY CONTEXT

WHO TRS 996 Annex 5 sets out good data and record management practices, including contemporaneous recording, corrections and the control of records, and MHRA GxP DI (2018) sets the expectations for records that are attributable, legible, contemporaneous, original and accurate. Neither prescribes your correction convention, which records require second-person review, or how a signature register is maintained — those determinations are yours. The five-requirement framing is SPEQ practitioner synthesis.

MAPPED STANDARDS
WHO TRS 996, Annex 5MHRA GxP DI (2018)
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