SOP: Good Documentation Practices (GDocP)

This is a ready-to-use SOP for good documentation practices on paper and hybrid GxP records. Replace every <<FILL: ...>> placeholder with your own specifics, set your document numbers and dates, and route it through your normal document control, review, and approval. A worked filled specimen follows the template so you can see how a completed version reads. This content is educational and general; adapt and verify it for your operation, and confirm each cited regulation against the current source before you rely on it.

Document control header

1. Purpose

This procedure defines how <<FILL: COMPANY NAME>> makes, corrects, attributes, and controls entries in GxP records so that each record is attributable, legible, contemporaneous, original, and accurate, and remains complete, consistent, enduring, and available. It translates the ALCOA+ properties into the day-to-day mechanics every person follows when they write on a controlled record or in a logbook.

2. Scope

This procedure applies to all hand-recorded and hybrid GxP records at the sites in the header: batch records, laboratory worksheets, logbooks, controlled forms, labels, and any paper record that supports a GxP decision. For records created and signed in computerized systems, the equivalent controls (audit trail, unique accounts, electronic signatures) are governed by <<FILL: SOP-ID for electronic records / Part 11>> and the system validation; this SOP still governs any printout, true copy, or hand entry associated with those systems.

3. Responsibilities

4. Definitions

• Contemporaneous: recorded at the time the action, result, or observation occurs, not reconstructed later from memory or notes.
• Attributable: traceable to the one person who made the entry, through the signature register (paper) or a unique account (electronic).
• Late entry: an entry made after the moment of the event, recorded transparently with both the event time and the actual time of writing, plus a reason.
• Controlled form: a form that exists in a single approved version, is issued under control, and is reconciled after use.
• True copy: a copy verified to preserve the full content and meaning of an original, including relevant metadata.
• N/A: “not applicable”, entered in a field that genuinely does not apply, so the field is not left blank.

5. Procedure

5.1 Record contemporaneously

1. Record each result, action, or observation at the time it happens, in the field provided.
2. Use the controlled system clock or a synchronized timepiece for times; do not free-type a guessed time.
3. Do not pre-record steps not yet done, and do not batch-record at end of shift work performed over hours.

5.2 Make a controlled late entry when real-time recording was not possible

1. Write the entry in the correct field or the next available space, with a clear pointer to the step it relates to.
2. Record both the time the event actually occurred and the actual time you are writing the entry.
3. Add a short reason it is late.
4. Initial and date. Never write a later entry as if it had been made at the moment; that is back-dating and is treated as falsification.

5.3 Attribute every entry

1. Make entries in your own name only; sign or initial your own work.
2. Use the initials and signature recorded for you in the signature register (<<FILL: signature register ID>>); resolve any initial collision using the disambiguator defined there.
3. On electronic systems, use only your own unique account; never share a login or password.
4. A verifier or witness signs only for a check they personally performed at the time.

5.4 Correct an error with the single-line method

1. Draw one line through the erroneous entry so the original stays legible.
2. Write the correct value nearby with a clear pointer.
3. Add your initials and the date, and a short reason for any significant correction.
4. Never erase, white-out, scribble out, or write over the original. Never use pencil or erasable ink.

5.5 Leave no blanks

1. Complete every field on a controlled form.
2. Where a field genuinely does not apply, enter “N/A” (and initial/date where the form requires).
3. Strike a single diagonal line through unused space on a partially used page so nothing can be added later.

5.6 Preserve raw data and round only where specified

1. Record raw data at the full resolution the instrument provides.
2. Apply rounding and significant figures only at the step the method specifies, never before.
3. Retain the original instrument reading or printout as the original record.

5.7 Use controlled forms and bound logbooks

1. Use only the current approved version of a form; an entry on a superseded version is a deviation.
2. Issue, log, and reconcile blank batch records and critical forms so issued copies equal used plus voided (<<FILL: form issuance log ID>>).
3. Void a spoiled form (mark VOID, single-line, initial, date, reason) and retain it; do not discard it.
4. Use bound, pre-numbered logbooks; make entries in sequence with no skipped lines (single-line and initial any skipped line); never remove a page.

5.8 Handle printouts and fading originals

1. For thermal or fading printouts, make a verified true copy and have a second person confirm it is complete and faithful, then retain the true copy as the controlled record, or capture the data electronically at the source.
2. Define which version is the designated original and retain it for the full retention period in a readable form.

5.9 Review and approve

1. An independent reviewer (not the person who did the work) confirms completeness, correct corrections, plausible forward sequence, results within limits or linked to an open investigation, and the required signatures, plus the audit trail for hybrid records.
2. Reviewers sign only what they actually reviewed, contemporaneously; pre-signing blank reviews is prohibited.

6. Acceptance criteria

A record meets GDocP when all of the following hold:

• Every entry was made by the person who did the work, at or immediately after the moment, with any late entry flagged with both times and a reason.
• Every entry, correction, and signature resolves to one named individual; no shared logins exist.
• Corrections are single-lined, legible, initialed, dated, and reasoned where significant; no obliteration anywhere.
• No blank fields; N/A used correctly; unused space struck through.
• Raw data captured at full resolution; rounding applied only at the defined step.
• Forms in use are the current version; issued copies reconcile against used plus voided; logbooks are bound, sequential, and complete.
• The record is independently reviewed and signed by qualified people.

7. Records generated

• Completed GxP records, logbooks, and forms governed by this SOP.
• Signature register (<<FILL: ID>>).
• Controlled form issuance and reconciliation log (<<FILL: ID>>).
• Deviations raised for any GDocP failure (<<FILL: deviation SOP-ID>>).

8. References

21 CFR 211.68, 211.100(b), 211.160(a), 211.180-211.198 (cGMP records and the at-the-time-of-performance expectation). 21 CFR Part 11 (electronic records and signatures), for hybrid and electronic equivalents. EU GMP Guide Chapter 4 (Documentation) and Annex 11 (Computerised Systems). WHO TRS 996 Annex 5 (good data and record management practices). MHRA ‘GXP’ Data Integrity Guidance and Definitions; PIC/S PI 041.

Confirm the current version and clause numbers of each reference before issue.

9. Revision history

10. Approvals

Filled specimen

The following shows how three common situations are handled under this SOP on a paper batch record. The names, times, and numbers are illustrative; replace them with your own.

A contemporaneous entry, then a correction:

Step 4, dispensed mass: 12.06 g 12.60 g /AB 30-Jun-2026, transposition error/

A controlled late entry:

Step 7, mixing start: 09:14 (event occurred 09:14, recorded as late entry 09:52 on exit from gowning; reason: form not available inside the suite. /AB 09:52 30-Jun-2026/)

An N/A and a struck-through unused field:

Step 11, second filtration: N/A (single-pass process, second filtration not required) /AB 30-Jun-2026/. Remaining blank lines on the page struck with a single diagonal line, initialed AB.

A reviewer signing this record would confirm the cross-out is single-lined and legible, both times are present on the late entry, the N/A is justified, and no field is left open. That is the standard this SOP is built to produce, entry by entry.

Common inspection findings this SOP prevents

• Records that look written in one sitting, with uniform ink and round times across a long operation.
• Back-dated entries dressed as contemporaneous.
• Corrections by white-out, scribble, or overwrite, or corrections with no initials.
• Blank fields, or N/A used to skip a step that should have happened.
• Shared or generic logins on hybrid systems.
• Spare blank forms, superseded form versions in use, or logbooks with missing pages or open lines.
• Pre-signed reviews dated before the work could have been completed.

How to adapt this SOP

1. Set your document number, owner, and effective date in the header.
2. Point the cross-references in sections 2, 5.3, 5.7, and 7 to your real Part 11, signature register, form issuance, and deviation procedures.
3. Align the rounding and significant-figure rule in 5.6 with your analytical methods.
4. If you operate fully electronic in some areas, state where this SOP applies versus where the system controls take over.
5. Confirm every regulation in section 8 against the current published version before issue.