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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.

Seal open on SOP-FIL-007, Aseptic filling, a controlled procedure: version 13, in force on Line 2 since Tue 10 Nov 21:34, with the text of its filling steps and every version with the lots that ran on it. Linked are step 4.3 of Line 2's batch record, which calls it, lot 26-0918, the first on it, version 12 and lot 26-0917, which ran on version 12, the training of all eleven Line 2 operators, changeset #15, which made it, and change notice CN-112 to Rookery Bio, the client. Each opens, and versions 10 to 12 open to what the text said then.
Documents › Procedures › SOP-FIL-007
v13 effective

DEV-041 Line 2 stop not in the record

Lot 26-0917. Opened by S. Amato, Tue 10 Nov 08:30

  1. Detected
  2. Drafted
  3. QA triage
  4. Investigation
  5. CAPA
  6. Closed
Lot 26-0917's record, step 4.3

T. Nowak, Fri 6 Nov 10:00, signed
Filler F-02, read each second by Seal Edge

Line 2's shift channel, 02:11

Lot 26-0917 Step 4.3 Stopper feed

mAb-24 for Rookery Bio. Filled Fri 6 Nov on Line 2

  1. Dispense
  2. Formulate
  3. Filter
  4. Fill
  5. Cap
  6. Inspect
  7. Label
  8. Pack
  9. QA review
The record, step 4.3F-02A. OkaforRunningA. OkaforRunning T. Nowak

CAPA-019 Stopper bowl jams

Opened by DEV-041's review, Tue 10 Nov 09:07. Owner T. Nakamura

  1. Opened
  2. Actions
  3. Effectiveness
  4. Closed
Effectiveness: ten lots on the new feed track without a jam

1 of 10

  1. 0921
  2. 0922
  3. 0923
  4. 0924
  5. 0925
  6. 0926
  7. 0927
  8. 0928
  9. 0929
  10. 0930
26-0918 to 0920Wed 11 to Fri 13 NovWorn track, hourly checkNot counted
Mon 16 NovNew track, 1.8 A, no jamCounted
Tue 17 NovNew track, 1.8 AFor QA to check
26-0930The tenthThen it can close

Changeset #15 Aseptic filling, v12 to v13

Proposed by Neil, Tue 10 Nov 09:31, from DEV-041's review

  1. Proposed
  2. Tested
  3. Approved
  4. Trained
  5. Effective
SOP-FIL-007 step 4.3 Stopper feed, v12 to v13

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.

Proposed to approved

  1. Proposed09:31Neil
  2. Tested09:5412 of 12
  3. Production10:40K. Brandt
  4. QA approved11:20S. Amato

SOP-FIL-007 Aseptic filling

Procedure for Line 2. Owner K. Brandt, Production

  1. Proposed
  2. Tested
  3. Approved
  4. Trained
  5. Effective
v13
4FillingStep 4.3 changed in v13
  1. 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.
  2. 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.
  3. 4.4RestartBefore restarting, reject the open vials between the needles and the stoppering station, and record how many.
  1. v13Tue 10 Nov 21:34 to now
  2. Fri 2 Oct to Tue 10 Nov
  3. Mon 11 May to Fri 2 Oct
  4. Tue 3 Mar to Mon 11 May

Training SOP-FIL-007 v13, Line 2

Assigned at QA's approval, Tue 10 Nov 11:20. Owner K. Brandt

  1. Assigned
  2. Night shift
  3. All of Line 2
Trained on v13, of everyone who signs step 4.3

11 of 11

Night shift, before the fill
  • A. Okafor
  • J. Lindqvist
  • M. Rossi
  • R. Mensah
Day shift, before their next shift
  • T. Nowak
  • L. Ferreira
  • B. Adeyemi
  • C. Moreau
  • E. Sato
  • F. Kowalski
  • H. Quinn

CN-112 SOP-FIL-007 v13, to Rookery Bio

Sent by S. Amato, Tue 10 Nov 11:32

  1. Drafted
  2. Sent
  3. Acknowledged
Change notice to Rookery Bio, Tue 10 Nov

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.

  1. SentS. Amato, QA, on Rookery's lot in Seal Portal
  2. AcknowledgedD. Hale, QA, Rookery Bio
  3. Effective on Line 2Version 13, after the acknowledgement

Earlier lots Four jams, none recorded

Assessed by S. Amato, Fri 13 Nov

  1. Heard of
  2. Assessed
  3. Corrected
Before lot 26-0917's, heard of but never recorded

4 jams

LotFilledHeard in
Thu 27 AugShift handover
Wed 16 SepLine 2 stand-up
Thu 8 OctMaintenance log
Tue 20 OctShift 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

In force on Line 2 from Fri 2 Oct to Tue 10 Nov, 21:34

  1. Proposed
  2. Tested
  3. Approved
  4. Trained
  5. Effective
v12SupersededIn force Fri 2 Oct to Tue 10 Nov
4FillingStep 4.2 changed in v12
  1. 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.
  2. 4.3Stopper feedCheck the stopper bowl through the glass every 2 hours during filling.
  3. 4.4RestartBefore restarting, reject the open vials between the needles and the stoppering station, and record how many.
  1. Tue 10 Nov 21:34 to now
  2. v12Fri 2 Oct to Tue 10 Nov
  3. Mon 11 May to Fri 2 Oct
  4. Tue 3 Mar to Mon 11 May

SOP-FIL-007 v11 Aseptic filling

In force on Line 2 from Mon 11 May to Fri 2 Oct

  1. Proposed
  2. Tested
  3. Approved
  4. Trained
  5. Effective
v11SupersededIn force Mon 11 May to Fri 2 Oct
4FillingStep 4.3 changed in v11
  1. 4.2Fill weightEvery 30 min, weigh 10 vials on B-04 and record their mean. Limits 10.00 to 10.40 g.
  2. 4.3Stopper feedCheck the stopper bowl through the glass every 2 hours during filling.
  3. 4.4RestartBefore restarting, reject the open vials between the needles and the stoppering station, and record how many.
  1. Tue 10 Nov 21:34 to now
  2. Fri 2 Oct to Tue 10 Nov
  3. v11Mon 11 May to Fri 2 Oct
  4. Tue 3 Mar to Mon 11 May

SOP-FIL-007 v10 Aseptic filling

In force on Line 2 from Tue 3 Mar to Mon 11 May

  1. Proposed
  2. Tested
  3. Approved
  4. Trained
  5. Effective
v10SupersededIn force Tue 3 Mar to Mon 11 May
4Fillingv10
  1. 4.2Fill weightEvery 30 min, weigh 10 vials on B-04 and record their mean. Limits 10.00 to 10.40 g.
  2. 4.3Stopper feedCheck the stopper bowl through the glass at each top-up.
  3. 4.4RestartBefore restarting, reject the open vials between the needles and the stoppering station, and record how many.
  1. Tue 10 Nov 21:34 to now
  2. Fri 2 Oct to Tue 10 Nov
  3. Mon 11 May to Fri 2 Oct
  4. v10Tue 3 Mar to Mon 11 May

Step 4.3 Stopper feed

In Line 2's batch record for mAb-24. Runs through the whole fill

  1. Dispense
  2. Formulate
  3. Filter
  4. Fill
  5. Cap
  6. Inspect
  7. Label
  8. Pack
  9. QA review
Lot 26-0922, filled this morning on F-02

SOP-FIL-007 v13, step 4.3
Each lot's record keeps the version its step ran on
v13Lots 26-0918 to 26-0922
v12Lots 26-0912 to 26-0917

Lot 26-0918 Step 4.3 Stopper feed

mAb-24 for Rookery Bio. Filled Wed 11 Nov on Line 2, on v13

  1. Dispense
  2. Formulate
  3. Filter
  4. Fill
  5. Cap
  6. Inspect
  7. Label
  8. Pack
  9. QA review
Step 4.3 on SOP-FIL-007 v13

9 bowl checks, no jam

  1. A. Okafor
  2. A. Okafor
  3. A. Okafor
  4. By voice
  5. M. Rossi
  6. R. Mensah
  7. J. Lindqvist
  8. To 09:10
Served to the line: v13 only. Earlier versions open for reviewers, marked superseded

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.

Seal's document register on Tue 17 Nov at 16:00: seven of the documents in force on Line 2, each with its version, where it is used, its owner and its next periodic review. The work instruction for loading the stopper bowl, WI-FIL-011, is due for review on Fri 20 Nov. Neil gathers what has happened since its last review: version 13 of the filling procedure it serves, deviation DEV-041's five jams, supplier action SA-007 and the new feed track under CAPA-019. Its owner, K. Brandt, decides whether to retain, revise or retire it.
Documents › Register
For K. Brandt
In force on Line 2Tue 17 Nov, 16:00
Periodic reviewDue Fri 20 Nov

Loading the stopper bowl

WI-FIL-011 v3. Owner K. Brandt. Since its last review, Wed 20 Nov 2024

Decision, K. BrandtRetainReviseRetire
Each document with the version in force, where it is used and its next reviewNeil gathers what has happened since its last review, from the records that name itK. Brandt decides: retain, revise or retire. Neil decides nothingIn force since Tue 10 Nov 21:34. 11 of 11 trained. Owner K. Brandt, ProductionReviewed every two years; last on Wed 20 Nov 2024. Owner K. Brandt, ProductionWhat each lot of mAb-24 is made to, its bulk hold limit 36 h among it50 checks. Version 7 drafted by Neil from AUD-026, Fri 13 Nov; its test cases are with R. HaldaneSettle, contact and glove plates, and PC-02's particle counts, for each fillThe method lot 26-0917's endotoxin run and its retest followedHalden's certificates are checked against it at goods-inThe procedure this instruction serves: the bowl checked every hour, a jam cleared as INT-07 and recordedLot 26-0917's stop and the four before it, heard in handovers and the shift channelSiliconisation data for the stoppers in the jammed fills, asked of Halden by L. Haddad. Reply due Fri 20 NovThe stopper feed track on F-02 replaced Sat 14 Nov, T. Nakamura

What the procedure said that night.

A lot opens to the version its operators followed, and to who was trained on it then.

Lot 26-0917's step 4.3 in Seal, opened on Tue 17 Nov. SOP-FIL-007 version 13 says to check the stopper bowl every hour and to record a cleared jam. Going back to the night of the fill, Fri 6 Nov at 02:08, version 12 was in force, from Fri 2 Oct to Tue 10 Nov, and its step 4.3 said only to check the bowl through the glass every 2 hours. The entries made at the step that night, by A. Okafor, M. Rossi and T. Nowak, and the four operators of the night shift, each trained on version 12 between Thu 24 Sep and Wed 30 Sep, before it took effect.
Manufacturing › Batch records › Lot 26-0917
Then: v12

Step 4.3 Stopper feed

Filled Fri 6 Nov on Line 2
SOP-FIL-007 in force
  1. v103 Mar to 11 May
  2. v1111 May to 2 Oct
  3. v122 Oct to 10 Nov
  4. v1310 Nov to now
Step 4.3, as it readv12

Check 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.

In force since Tue 10 Nov, 21:34

Changed by v13, from v12

A check every hour, not every 2. A jam stops the line, is cleared as INT-07 and recorded.

Check the stopper bowl through the glass every 2 hours during filling.

In force Fri 2 Oct to Tue 10 Nov, 21:34. Approved by S. Amato, Thu 3 Sep.

Not in it: added by v13, Tue 10 Nov

If it jams, stop the line. Clear it as intervention INT-07. Record it before restarting.

Entered at step 4.3Fri 6 Nov
Night shift, trained on v124 of 4
  1. A. OkaforThu 24 Sep
  2. J. LindqvistFri 25 Sep
  3. R. MensahTue 29 Sep
  4. M. RossiWed 30 Sep
Step 4.3 as SOP-FIL-007 reads todayBack to the fill, Fri 6 Nov 02:08: version 12 was in forceThe night shift was trained on v12 before it took effect. The record keeps v12, as it ranThe night shift's first entry at the step, as the fill beganEntry 536 of 1,912; the lot scanned from the bag's labelRecorded at the restart, as step 4.4 asks. The 21 min stop before it was notDue 2 hours after the bowl was loaded, as v12 asked, then every 2 hours. v12 asked for a look through the glass, and nothing about a jamDay shift, trained on v12 Mon 28 Sep. Complete by v12's own words, which never named a cleared jam

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.

Changeset #16 in Seal on Tue 17 Nov: a draft of version 7 of RC-014, Blubber's record review checklist, drafted by Neil from audit finding AUD-026. It adds check C-51: every stop of filler F-02 during the fill has its intervention recorded at step 4.3. Before anyone approves it, it lists what it reaches and who decides each: Neil's record review, evaluated again on lots 26-0909 to 26-0916; three test cases for R. Haldane in Validation; two QA reviewers to train; lot 26-0922's review; the audit finding it answers; and Rookery Bio, the client, to whom Neil proposes no notice, for S. Amato to confirm.
Quality › Change control › Changeset #16
With R. Haldane

RC-014 v6 to v7

Owner S. Amato
  1. Proposed
  2. Tested
  3. Approved
  4. Trained
  5. Effective
Record review checklist50 checks to 51

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”

What it reachesWho decides
Drafted by Neil from AUD-026, Fri 13 Nov. Nothing in it is decided yetNeil's own review runs on RC-014, so v7 is evaluated again before it is usedA review already under way keeps the version it began on. Lot 26-0922's is QA's callNeil proposes no notice to Rookery Bio, and says why. S. Amato decidesNext: R. Haldane approves the test cases, then they run on v7On the same 8 lots, 26-0909 to 26-0916, for R. Haldane and S. Amato to approve. C-51 should find the stops in 26-0912 and 26-0914, entered only by late entryA stop with no step 4.3 entry fails C-51. A stop recorded as INT-07 meets it. Lot 26-0917's record fails itEveryone who confirms RC-014's checks. The operators are not affectedWork started on v6 stays on v6 unless QA decides otherwise. Lot 26-0922 was filled this morningInternal audit, Thu 12 Nov: “Shift channel not read against the record”Neil proposes no notice: RC-014 is QA's own review, not a change to the process the quality agreement covers

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

  • Bioventix80% less document admin time
  • Acclinate50% shorter quality cycle times and 40% less time preparing for audits

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.