Procedures. Versions. Training. Periodic review. DMS. One version in force, everywhere it is used.
Each procedure is linked to the batch record steps that call it, the people trained on it and the lots that ran on each version. Neil drafts; your QA approves.
DEV-041 Line 2 stop not in the record
- Detected
- Drafted
- QA triage
- Investigation
- CAPA
- Closed
Lot 26-0917 Step 4.3 Stopper feed
- Dispense
- Formulate
- Filter
- Fill
- Cap
- Inspect
- Label
- Pack
- QA review
CAPA-019 Stopper bowl jams
- Opened
- Actions
- Effectiveness
- Closed
1 of 10
- 0921
- 0922
- 0923
- 0924
- 0925
- 0926
- 0927
- 0928
- 0929
- 0930
| 26-0918 to 0920 | Wed 11 to Fri 13 Nov | Worn track, hourly check | Not counted |
| Mon 16 Nov | New track, 1.8 A, no jam | Counted | |
| Tue 17 Nov | New track, 1.8 A | For QA to check | |
| 26-0930 | The tenth | Then it can close |
Changeset #15 Aseptic filling, v12 to v13
- Proposed
- Tested
- Approved
- Trained
- Effective
Check the stopper bowl through the glass every 2 hours hour during filling. If it jams, stop the line. Clear it as intervention INT-07. Record it before restarting.
- Proposed09:31Neil
- Tested09:5412 of 12
- Production10:40K. Brandt
- QA approved11:20S. Amato
SOP-FIL-007 Aseptic filling
- Proposed
- Tested
- Approved
- Trained
- Effective
- 4.2Fill weightEvery 30 min, weigh 5 vials from each pump on B-04 and record each pump's mean. Limits 10.00 to 10.40 g.
- 4.3Stopper feedCheck the stopper bowl through the glass every hour during filling. If it jams, stop the line. Clear it as intervention INT-07. Record it before restarting.
- 4.4RestartBefore restarting, reject the open vials between the needles and the stoppering station, and record how many.
- v13Tue 10 Nov 21:34 to now
- Fri 2 Oct to Tue 10 Nov
- Mon 11 May to Fri 2 Oct
- Tue 3 Mar to Mon 11 May
Training SOP-FIL-007 v13, Line 2
- Assigned
- Night shift
- All of Line 2
11 of 11
- A. Okafor
- J. Lindqvist
- M. Rossi
- R. Mensah
- T. Nowak
- L. Ferreira
- B. Adeyemi
- C. Moreau
- E. Sato
- F. Kowalski
- H. Quinn
CN-112 SOP-FIL-007 v13, to Rookery Bio
- Drafted
- Sent
- Acknowledged
SOP-FIL-007 version 13: the stopper bowl is checked every hour, and a jam is cleared as INT-07 and recorded before the restart.
- SentS. Amato, QA, on Rookery's lot in Seal Portal
- AcknowledgedD. Hale, QA, Rookery Bio
- Effective on Line 2Version 13, after the acknowledgement
Earlier lots Four jams, none recorded
- Heard of
- Assessed
- Corrected
4 jams
| Lot | Filled | Heard in |
|---|---|---|
| Thu 27 Aug | Shift handover | |
| Wed 16 Sep | Line 2 stand-up | |
| Thu 8 Oct | Maintenance log | |
| Tue 20 Oct | Shift channel |
Each fill's plates in limits, sterility passed, the open vials rejected each time. No product impact, no recall.
SOP-FIL-007 v12 Aseptic filling
- Proposed
- Tested
- Approved
- Trained
- Effective
- 4.2Fill weightEvery 30 min, weigh 5 vials from each pump on B-04 and record each pump's mean. Limits 10.00 to 10.40 g.
- 4.3Stopper feedCheck the stopper bowl through the glass every 2 hours during filling.
- 4.4RestartBefore restarting, reject the open vials between the needles and the stoppering station, and record how many.
- Tue 10 Nov 21:34 to now
- v12Fri 2 Oct to Tue 10 Nov
- Mon 11 May to Fri 2 Oct
- Tue 3 Mar to Mon 11 May
SOP-FIL-007 v11 Aseptic filling
- Proposed
- Tested
- Approved
- Trained
- Effective
- 4.2Fill weightEvery 30 min, weigh 10 vials on B-04 and record their mean. Limits 10.00 to 10.40 g.
- 4.3Stopper feedCheck the stopper bowl through the glass every 2 hours during filling.
- 4.4RestartBefore restarting, reject the open vials between the needles and the stoppering station, and record how many.
- Tue 10 Nov 21:34 to now
- Fri 2 Oct to Tue 10 Nov
- v11Mon 11 May to Fri 2 Oct
- Tue 3 Mar to Mon 11 May
SOP-FIL-007 v10 Aseptic filling
- Proposed
- Tested
- Approved
- Trained
- Effective
- 4.2Fill weightEvery 30 min, weigh 10 vials on B-04 and record their mean. Limits 10.00 to 10.40 g.
- 4.3Stopper feedCheck the stopper bowl through the glass at each top-up.
- 4.4RestartBefore restarting, reject the open vials between the needles and the stoppering station, and record how many.
- Tue 10 Nov 21:34 to now
- Fri 2 Oct to Tue 10 Nov
- Mon 11 May to Fri 2 Oct
- v10Tue 3 Mar to Mon 11 May
Step 4.3 Stopper feed
- Dispense
- Formulate
- Filter
- Fill
- Cap
- Inspect
- Label
- Pack
- QA review
| v13 | Lots 26-0918 to 26-0922 | |
| v12 | Lots 26-0912 to 26-0917 |
Lot 26-0918 Step 4.3 Stopper feed
- Dispense
- Formulate
- Filter
- Fill
- Cap
- Inspect
- Label
- Pack
- QA review
9 bowl checks, no jam
- A. Okafor
- A. Okafor
- A. Okafor
- By voice
- M. Rossi
- R. Mensah
- J. Lindqvist
- To 09:10
Every document, where it is in force.
Each shows its version in force, where it is used and who owns it. A review comes due with what has happened since the last.

Loading the stopper bowl
WI-FIL-011 v3. Owner K. Brandt. Since its last review, Wed 20 Nov 2024
What the procedure said that night.
A lot opens to the version its operators followed, and to who was trained on it then.

Step 4.3 Stopper feed
Filled Fri 6 Nov on Line 2- v103 Mar to 11 May
- v1111 May to 2 Oct
- v122 Oct to 10 Nov
- v1310 Nov to now
- A. OkaforThu 24 Sep
- J. LindqvistFri 25 Sep
- R. MensahTue 29 Sep
- M. RossiWed 30 Sep
See what a draft reaches before anyone signs.
Neil drafts the revision and lays out every check, person, record and notice it touches, each for the one who decides.

RC-014 v6 to v7
Owner S. Amato- Proposed
- Tested
- Approved
- Trained
- Effective
C-50Every deviation raised during the lot is linked to it.
C-51Every stop of F-02 during the fill has an entry at step 4.3: an intervention, with its start, end and rejected vials.
What C-51 would find in lot 26-0917's recordF-02 stopped 02:08 to 02:29. Nothing entered at step 4.3.
From AUD-026, Thu 12 Nov“Shift channel not read against the record”
Questions about DMS.
How is this different from a document library?
The distinction is the connection to execution. Seal links the procedure to its training requirements, forms, quality changes and the laboratory or manufacturing records it governs. You can assess and implement the operational impact of a revision in the same platform, rather than reconcile separate lists of files, people and tasks.
Can we use document control without replacing every system?
Yes. Start with a document family and the relationships needed for its intended use. Agree which system owns each record and how existing systems exchange information. Add training, quality or execution workflows in Seal as the scope grows.
Does every revision require retraining?
No blanket rule should replace the impact assessment. The change type, affected roles and intended activity determine whether acknowledgement, instruction, assessment or practical qualification is appropriate. Keep the rationale and required evidence with the revision.
Can an approved document wait before becoming effective?
Approval and effectiveness are distinct. Define the implementation conditions and cutover date for the configured workflow, including applicable training, verification and copy reconciliation. The outgoing instruction remains effective until the replacement is ready for controlled use.
What happens to existing records when a procedure changes?
Previously created records retain the version and history used for that work. Decide how open work is handled during cutover as part of the impact assessment; do not silently reinterpret it under the new instruction. New work uses the version made effective for its scope.
Can reviewers still see obsolete versions?
Historical versions remain part of the evidence available to authorised users. Point-of-use access should make the effective instruction clear, while reviewers and investigators can trace the earlier content, approvals and executions.
How does Neil help with document control?
Neil can help draft structured instructions, compare changes, find the records that use an instruction and prepare an impact assessment from permitted sources. People verify the content and completeness of the assessment. Neil does not supply a required person’s signature or bypass release controls.
Are our procedures used to train AI models?
No. Customer data is not used to train AI models. Records in Seal provide working context for Neil; that is different from training the underlying model. Neil follows the requester’s access permissions.
How do paper copies fit into the process?
Define how copies are issued, identified, located and reconciled. Link each copy record to its document version and plan replacement during cutover. A system cannot physically recall a printout, so the responsible person’s confirmation remains important.
Can we control external standards and supplier documents?
Yes. Keep the external source’s issuer, identifier, edition, owner and applicability. Assess replacements against the local documents and processes that depend on them. Internal acceptance of an external edition is separate from authorship or approval by its issuer.
How do we validate changes to executable procedures?
Assess the affected intended use, requirements and configuration. Keep the specifications, automated verification, repeatable UAT evidence and required approvals with the proposed version. The checks should match risk and scope; changing prose and changing an execution gate are different cases.
How should we migrate from an existing system?
Start with an agreed inventory and mapping for document types, owners, versions, references and approval evidence. Trial the import, resolve exceptions and reconcile the population before approving the baseline. The schedule depends on source quality and scope; missing history must remain an explicit exception.
Measured by customers
In depth
The DMS guide9 sections, with figures and references
All 8 capabilities
- Procedure management
- Keep the procedure’s owner, scope, instructions, references and lifecycle together. Distinguish the effective version from the revision being prepared.
- Approval workflows
- Bring the change proposal and its impact into review. Required people and signatures govern approval; implementation readiness governs effective use.
- Training integration
- Assess training impact by role and activity. Retain assignments and qualification evidence against the relevant procedure version.
- Controlled distribution
- Connect effective instructions to point-of-use access and copy records. Include replacement and reconciliation of physical copies in the change plan.
- AI document drafting
- Ask Neil to help draft from source instructions, compare revisions and prepare impact questions. Review the proposal before it becomes the next controlled version.
- Periodic review
- Set the review interval and owner. Consider source changes, deviations and feedback, then record whether to retain, revise or retire the instruction.
- Full audit trail
- Follow a change to its version, recorded actions and approval evidence. Earlier executions retain the instruction and configuration used at the time.
- Migration support
- Map document types, owners, versions and references. Reconcile the imported population and review the baseline before operational use.


See your process in Seal.
Working 48 hours after we agree its scope: tested, with evidence your QA approves.