This is a ready-to-use work instruction for two everyday acts on a paper or hybrid GxP record: correcting a mistake, and recording something after the moment it happened. It sits under the parent SOP <<FILL: GDocP SOP-ID, e.g. SOP-QA-002>> and gives the exact step-by-step actions, with the acceptance for each step. Replace every <<FILL: ...>> placeholder. A filled specimen follows. This is general guidance to adapt and verify, not legal or regulatory advice.
Header
| Field | Entry |
|---|---|
| Work instruction number | <<FILL: WI-ID, e.g. WI-QA-002-01>> |
| Parent SOP | <<FILL: GDocP SOP-ID>> |
| Version / effective date | <<FILL>> |
| Applies to | <<FILL: roles that write on GxP records>> |
When to use this work instruction
Use it whenever you need to change an entry you already wrote, or record an event you could not capture at the moment it happened. Do not use it to alter a record after it has been reviewed and approved; a post-approval change goes through the amendment route in the parent SOP.
Tools and materials
- The original controlled record or logbook.
- Approved indelible pen (blue or black; never pencil, never erasable ink).
- Your initials and signature as recorded in the signature register
<<FILL: ID>>.
Task A: correct an error (single-line cross-out)
| Step | Action | Acceptance for this step |
|---|---|---|
| A1 | Draw a single straight line through the wrong entry. | The original value is still fully legible through the line. |
| A2 | Write the correct value next to it (above, beside, or in the margin with a clear pointer). | The correct value is unambiguous and clearly linked to the field. |
| A3 | Add your initials and the date next to the correction. | The correction is attributable and dated. |
| A4 | For any significant correction, add a short reason. | A reviewer can tell why the change was made (for example “transcription error”, “wrong units”). |
| A5 | Do not erase, white-out, scribble over, or write over the original. | No obliteration; the first entry remains readable. |
Allowed versus not allowed
| Action | Allowed? | Why |
|---|---|---|
| Single line, correct value, initials, date | Yes | Original stays legible; change is attributable and dated |
| Multiple lines or scribble until unreadable | No | Destroys the original; reads as concealment |
| Correction fluid or opaque marker | No | Obliterates; flagged as falsification risk |
| Writing over the original digit | No | Cannot tell original from correction |
| Erasing (pencil) | No | No durable record ever existed |
Task B: make a controlled late entry
| Step | Action | Acceptance for this step |
|---|---|---|
| B1 | Write the entry in the correct field, or in the next available space with a pointer to the step it relates to. | The entry is clearly tied to the right step. |
| B2 | Record the time the event actually occurred. | The real event time is captured. |
| B3 | Record the actual date and time you are writing the entry. | Both times are present and different where the gap is real. |
| B4 | Add a short reason the entry is late. | The reason is specific (for example “recorded on exit from aseptic suite”). |
| B5 | Initial and date. | The late entry is attributable. |
The line between a defensible late entry and falsification is honesty about timing. Showing both times is what makes it defensible. Writing the entry as if it had been made at the moment is back-dating.
What to do if you are unsure
If a correction would change a result, a pass/fail, or a release-relevant value, or if you find an entry that looks back-dated or obliterated, stop and notify your supervisor and Quality Assurance the same working day, and raise a deviation per <<FILL: deviation SOP-ID>>. Do not “tidy up” a record on your own judgment.
Filled specimen
Task A, a correction done right:
pH reading:
7.427.24 /AB 30-Jun-2026, transcription error/
The reader still sees 7.42, sees the corrected 7.24, and knows who changed it, when, and why.
Task B, a late entry done right:
Step 7, mixing start time: 09:14 (event occurred 09:14, recorded as late entry 09:52 on exit from gowning; reason: form not available inside suite. /AB 09:52 30-Jun-2026/)
Common mistakes this work instruction prevents
- A correction with no initials, which makes the change unattributable and casts doubt on every correction in the record.
- White-out or a heavy scribble, which an inspector reads as concealment even when it was an honest typo.
- A late entry written with only the event time, which is indistinguishable from back-dating.
- “Tidying” an approved record without the controlled amendment route.
How to adapt
- Set your WI number and parent SOP, and confirm your site’s approved pen and signature-register references.
- If your area uses a controlled reason-code list for corrections, attach it and reference it in step A4.
- Confirm the deviation and amendment cross-references point to your real procedures.