Quality attention

Decision-record exposure, in one operating view.

See which consequential decisions need attention, where material gaps are recurring, and which records are stalled before inspection pressure makes reconstruction necessary.

DEMO DATA · Updated Aug 22, 2026

Management insight

Evidence Connection has appeared in 4 of the last 6 months across 3 decision types.

The recurring pattern suggests the organization is repeatedly failing to preserve the link between evidence and decision, even where individual records are being closed.

May–Aug 2026 · batch disposition, deviation disposition, supplier exception ·

What Needs Attention

4 priority items

Recent Activity

Governed record events

Today · 09:42	IRR-024-118 moved to Authorization	Maya Chen
Today · 08:18	DRA-024-131 completed — material gaps identified	Daniel Ruiz
Aug 21 · 16:05	Controlled amendment 01 authorized	Priya Shah
Aug 21 · 11:27	IRR-024-109 completed and locked	Alex Morgan

Recurring Decision-Record Gaps

Five Gap analysis · Last 90 days

Recurring pattern

Evidence Connection appears in 7 of the 9 material-gap assessments and was the leading finding for three consecutive months. Evidence is being gathered; which evidence the decision turned on is not being recorded.

Relevant Case File

Licensed

02

Batch Release AuthorizationWorked consequential-decision scenarioCF02 · Licensed to demo tenant

What this demonstrates: the IRR governs one consequential decision. The Workspace gives Quality leadership persistent visibility across recurring decision-record activity. Every metric above opens the underlying synthetic records — what the decisions were, who owns them, why each matters, and what is due next.

Decision Inbox

How a consequential decision gets into the Workspace.

Four intake routes, and only four. Each one ends in the same place — an assessed decision record with its source reference preserved and a Decision Reconstruction Assessment as the next step. No integration is required for any of them, and the source record stays in the system it already lives in.

DEMO DATA · Nothing is stored

Recently captured

Six recent decisions · all four origin routes

Record ID	Origin	Source reference	Decision summary	Status
DRA-024-134	Manual entry	PKG-26-051	Secondary packaging deviation accepted with 100% inspection	Assessed · Defensible
DRA-024-131	Uploaded document	II-8841	Stopper dimensional variance, Lot ST-8841	Assessed · Material gaps
DRA-024-130	Manual entry	BR-24S-130	Batch 24S-130 released — dissolution at lower specification bound	Assessed · Minor gaps
DRA-024-118	Manual entry	INV-26-204	Sterility excursion disposition, Batch 24F-118	Assessed · Material gaps
DRA-024-128	DDA/DRA assessment	CAPA-26-011	CAPA-26-011 extended rather than closed	Assessed · Minor gaps
DRA-024-123	Spreadsheet import	EMT-Q3-26	Grade A action-limit excursion trended as isolated	Assessed · Defensible

Origin labels in use

Manual entry 12 · Uploaded document 6 · Spreadsheet import 3 · DDA/DRA assessment 3 · Future QMS trigger not available — a QMS-triggered origin is an optional future connection, not a live one. There is no email intake route: nothing is ever sent to ComplianceWorxs by email.

Why origin is recorded

Where a decision came from changes how much of it was already written down. Manually captured decisions arrive with reasoning intact; decisions reconstructed from an uploaded document or a spreadsheet row arrive with the conclusion and very little of the judgment behind it.

Integration readiness

Optional future connections

Veeva QualityDocs / Vault QMSDocument and QMS record referencesNot connected

TrackWiseDeviation, CAPA and change triggersNot connected

MasterControlInvestigation and effectiveness-check triggersNot connected

ValdataMaterials, lot and batch record referencesNot connected

LIMSOOS / OOT result referencesNot connected

MESBatch and intervention event referencesNot connected

ERPLot, supplier and disposition referencesNot connected

What an integration would do

No integration is required to use the Workspace — all four intake routes work without one. An optional future enterprise connection would create a consequential-decision trigger and carry the source reference across. The underlying GMP records would stay in the customer's source system — ComplianceWorxs would point at them, not hold them. None of these integrations exists today, and none is connected in this demo.

Demonstration only: no file is uploaded, stored or parsed, no record is persisted, and no external system is contacted anywhere in this demo. Each intake surface shows the experience using pre-written synthetic content. There are four intake routes and no others — there is no email intake path of any kind in the product or in this demo, and the source record stays in the existing system in every case.

DRA-024-131 · DECISION ASSESSMENT

Supplier exception — stopper dimensional variance

Decision owner: Daniel RuizAssessment owner: Maya ChenDecision date: Aug 21, 2026Origin: Uploaded document · II-8841

Material gaps identified

Decision context

A dimensional variance was identified in incoming stopper inspection for Lot ST-8841. Supply continuity required a documented disposition before the scheduled fill campaign. Existing records captured test results and supplier correspondence but did not fully preserve the basis for accepting the variance.

Five Gap findings

Decision Reasoning · MaterialThe record states the disposition but does not connect the observed dimensional variance to the specific acceptance logic used.

Risk Judgment · MaterialProduct-impact judgment is referenced, but the uncertainty considered and the threshold for acceptable residual risk are not preserved.

Alternatives · PartialSupplier replacement and campaign delay were discussed but not documented as competing considerations.

Assessment outcome

Material reconstruction exposure identified.

The underlying GMP records show what occurred. They do not yet preserve enough of the evidence connection, decision reasoning, and risk judgment to explain why the exception was reasonable when made.

Recommended next action

Create an Inspection Response Record to preserve the decision basis, conditions, accountability, and authorization while the evidence remains current.

IRR-024-118 · INSPECTION RESPONSE RECORD

Batch 24F-118 — Sterility excursion disposition

Decision owner: Maya ChenQA reviewer: Alex MorganCreated: Aug 20, 2026Origin: DRA · DRA-024-118 · INV-26-204

Authorization

Draft

Evidence Review

Decision Owner Review

Authorization

Complete

The Record Behind the Decision

Decision context. An environmental monitoring excursion occurred during the fill campaign. The batch was held while investigation, organism identification, trend review, and product-impact evidence were evaluated.

Evidence reviewed. EM investigation INV-26-204; media-fill history; room trend data; intervention log; sterility results; batch record BR-24F-118.

Decision reasoning. The excursion was localized to a non-critical monitoring location after completion of the highest-risk intervention. Investigation evidence found no corresponding critical-zone excursion, no adverse personnel trend, and no product-test signal. The evidence supported treating the event as isolated rather than indicative of loss of aseptic control.

Risk judgment. Residual uncertainty remained because absence of a detected pathway cannot prove zero contamination risk. QA judged the residual risk acceptable only with the specified enhanced monitoring commitment.

Alternatives considered. Reject batch; extend hold pending additional incubation; release with enhanced monitoring condition. Rejection was not supported by the aggregate evidence; extended hold would not materially reduce the identified uncertainty.

Conditions & commitments. Trend the next three campaigns for the identified location and operator cohort. Escalate any repeat excursion to site Quality Council.

Authorization

Decision owner review: CompleteQA review: CompleteAuthorization: Awaiting authorized approver

Demo workflow state

This presentation shows the governed authorization state only. It does not represent a compliant regulatory electronic signature.

Completed record example

LOCKEDIRR-024-109 reached Complete on Aug 21. Substantive content cannot be silently overwritten; a change requires a controlled amendment and new audit event.

Connected ComplianceWorxs workflow

One consequential decision · Batch 24F-118

WorkspaceDecision captured

DRA-024-118 enters the portfolio from a manual entry against INV-26-204.

DRADecision assessed

The Decision Reconstruction Assessment tests the record against the Five Gaps.

DRAMaterial gap identified

Risk Judgment and Evidence Connection are material — the record cannot be reconstructed as written.

IRRIRR created

IRR-024-118 opens to preserve The Record Behind the Decision while the evidence is current.

Case FileReference standard applied

Case File 02 — Batch Release Authorization — is the licensed worked example the record is written against.

IRRCommitments & authorization

Enhanced-monitoring commitment recorded; authorization is the state the record sits in today.

WorkspaceExecutive View

The decision joins the recurring-exposure picture Quality leadership manages the portfolio from.

DRAAssesses the decision record and identifies which of the Five Gaps are material.

IRRGoverns The Record Behind the Decision for one consequential decision — evidence, reasoning, risk judgment, alternatives, conditions, authorization.

Case FileLicensed educational and reference IP. A worked consequential-decision scenario, not a customer record.

WorkspaceGoverns the portfolio — recurring exposure, commitments, ageing records and management attention across decisions.

Why this matters

These are not four separate tools that happen to share a customer. One decision — the Batch 24F-118 sterility excursion disposition — is assessed by the DRA, governed as a record by the IRR, written against a licensed Case File standard, and then managed as portfolio exposure by the Workspace.

Where the decision is now

Step 6. IRR-024-118 is complete, reviewed and evidenced; it is waiting on an authorized approver. Until that happens the batch stays on hold and the decision does not reach the Executive View as closed.

Executive view

Where decision-record exposure is recurring.

Management-level visibility into material gaps, aging records, commitments, and recurring patterns by consequential decision type.

DEMO DATA · 90-DAY VIEW

Management insight

Evidence Connection has appeared in 4 of the last 6 months across 3 decision types.

The recurring pattern suggests the organization is repeatedly failing to preserve the link between evidence and decision, even where individual records are being closed.

Present May, Jun, Jul and Aug 2026 · primary finding in three of those months · recurring in batch disposition, deviation disposition and supplier exception. Seven of the nine material-gap assessments carry it. This is a decision-recording behaviour, not a data-availability problem — and closing records faster does not fix it.

Reconstruction exposure trend

Mar – Aug 2026

Decisions assessedAssessments with material gaps

MarAprMayJunJulAug

Assessment volume is rising while the share with material gaps is falling — from 60% in March to 25% in August, in this synthetic example.

Recurring Decision-Record Gaps

Five Gap analysis · Last 90 days

Monthly exposure history

Is the same problem happening every month?

Month	Decisions assessed	Material gaps	Share	Primary Five Gap	Representative decision	Repeated from prior month?
Mar 2026	5	3	60%	Decision Reasoning	Deviation disposition — media-fill intervention	Baseline month
Apr 2026	6	4	67%	Decision Reasoning	Batch disposition — OOS retest release	Repeated from Mar
May 2026	6	3	50%	Evidence Connection	Supplier exception — resin lot substitution	New primary · Decision Reasoning still in 2 of 3
Jun 2026	8	4	50%	Evidence Connection	DRA-024-109 — visible particulate release	Repeated from May
Jul 2026	8	3	38%	Evidence Connection	DRA-024-127 — endotoxin OOS retest	Repeated · third consecutive month
Aug 2026	8	2	25%	Risk Judgment	DRA-024-131 — stopper dimensional variance	Evidence Connection still present in 1 of 2

Recurring pattern

Evidence Connection was the primary finding for three consecutive months (May–Jul) and is still present in August. Decision Reasoning led in two of the first three months and reappears in the August findings. Six bars, but not six unrelated problems.

Why this matters

The material-gap rate improving from 60% to 25% is not proof the problem is being fixed. Assessment volume rose 60% over the same period, so a falling share can coexist with an unchanged number of exposed decisions — 3 in March, 2 in August.

What requires action now

Repeated Evidence Connection and Decision Reasoning findings mean the upstream decision-recording behaviour has not changed. The Workspace is catching the gaps after the fact rather than the organization preventing them at the point of decision.

Owner / next action

Maya Chen · take the recurrence to the September Quality Council with a proposal to capture evidence-to-reasoning links at the point of disposition, not at assessment.

Recurring patterns by decision type

Management attention

Decision type	Assessed	Material gaps	Primary recurring gap	Open IRRs
Batch disposition	6	3	Evidence Connection	2
Deviation disposition	5	2	Evidence Connection	1
Supplier exception	4	2	Evidence Connection	1
Effectiveness check	3	1	Authorization	1
Change approval	3	1	Decision Reasoning	0
Investigation conclusion	2	0	None material	0
Environmental monitoring	1	0	None material	0
Total	24	9	Evidence Connection	5

Why this matters

Material gaps concentrate in the three decision types where a person had to weigh competing considerations — batch disposition, deviation disposition and supplier exception. They are absent from investigation conclusions and environmental monitoring, where the conclusion follows the data.

What requires action now

Batch disposition carries 3 of the 9 material gaps and 2 of the 5 open IRRs, including the one holding a batch today.

Executive question answered: Where are decision-record problems recurring, what requires management attention now, and is reconstruction exposure improving or increasing? Open any metric card above to see the underlying synthetic records.

Record ID	Origin · source reference	Decision type	Decision summary	Site / function	Decision owner	Assessed	DRA outcome	Linked IRR state
DRA-024-106	Manual entryBR-24F-106	Batch disposition	Batch 24F-106 released — fill-weight trend inside alert limit	Raleigh · Fill/Finish	Maya Chen	Jun 10	Defensible	—
DRA-024-108	Uploaded documentDEV-26-088	Deviation disposition	Grade C particle-count excursion closed as no product impact	Raleigh · Fill/Finish	Priya Shah	Jun 13	Defensible	—
DRA-024-109	Manual entryBR-24F-109	Batch disposition	Visible particulate observed at inspection, Batch 24F-109	Raleigh · Fill/Finish	Alex Morgan	Jun 18	Material gaps	IRR-024-109 · Complete (locked)
DRA-024-111	Uploaded documentSUP-26-311	Supplier exception	Resin lot substitution accepted for container closure	Supplier Quality	Daniel Ruiz	Jun 20	Minor gaps	—
DRA-024-112	Manual entryMF-26-04	Deviation disposition	Media-fill intervention count exceeded procedural limit	Raleigh · Fill/Finish	Priya Shah	Jun 24	Material gaps	IRR-024-112 · Complete (locked)
DRA-024-113	Spreadsheet importINV-26-158	Investigation conclusion	INV-26-158 root cause assigned to operator technique	Raleigh · Fill/Finish	Maya Chen	Jun 25	Defensible	—
DRA-024-115	DDA/DRA assessmentCAPA-25-338	Effectiveness check	CAPA-25-338 closed as effective	Raleigh · QC	Alex Morgan	Jun 27	Material gaps	IRR-024-115 · Authorization
DRA-024-117	Manual entryCC-26-072	Change approval	Filter supplier change approved on an equivalence rationale	Technical Services	Nadia Okafor	Jun 30	Material gaps	No IRR — remediated in QMS
DRA-024-119	Spreadsheet importDEV-26-119	Deviation disposition	Cleaning hold-time exceeded on Line 2	Cork · OSD	Sofia Lindgren	Jul 6	Minor gaps	—
DRA-024-120	Manual entryBR-24S-120	Batch disposition	Batch 24S-120 released after a label reconciliation variance	Cork · OSD	Priya Shah	Jul 8	Minor gaps	—
DRA-024-121	DDA/DRA assessmentCAPA-25-402	Effectiveness check	CAPA-25-402 effectiveness confirmed across three batches	Cork · OSD	Alex Morgan	Jul 10	Defensible	—
DRA-024-122	Manual entryDEV-26-122	Deviation disposition	Fill-line stoppage of 41 minutes during aseptic filling	Raleigh · Fill/Finish	Priya Shah	Jul 16	Material gaps	IRR-024-122 · Evidence Review
DRA-024-123	Spreadsheet importEMT-Q3-26	Environmental monitoring	Grade A action-limit excursion trended as isolated	Raleigh · Fill/Finish	Priya Shah	Jul 21	Defensible	—
DRA-024-124	Uploaded documentSUP-26-388	Supplier exception	Single-use assembly accepted below nominal gamma dose	Supplier Quality	Daniel Ruiz	Jul 24	Material gaps	No IRR — decision pending
DRA-024-125	Manual entryCC-26-091	Change approval	Sampling plan reduced following two years of trend data	Raleigh · QC	Nadia Okafor	Jul 27	Minor gaps	—
DRA-024-127	Manual entryLAB-26-091	Batch disposition	Endotoxin OOS retest disposition, Batch 24F-127	Raleigh · QC	Maya Chen	Jul 29	Material gaps	IRR-024-127 · Decision Owner Review
DRA-024-126	Uploaded documentINV-26-221	Investigation conclusion	INV-26-221 closed with no root cause determined	Raleigh · QC	Tom Byrne	Aug 4	Minor gaps	—
DRA-024-128	DDA/DRA assessmentCAPA-26-011	Effectiveness check	CAPA-26-011 extended rather than closed	Raleigh · QC	Alex Morgan	Aug 5	Minor gaps	—
DRA-024-129	Uploaded documentDEV-26-129	Deviation disposition	Temperature excursion during WIP hold, 3.2 h above range	Cork · OSD	Sofia Lindgren	Aug 14	Minor gaps	—
DRA-024-132	Manual entryCC-26-104	Change approval	Cleaning agent concentration change approved	Cork · OSD	Nadia Okafor	Aug 18	Defensible	—
DRA-024-118	Manual entryINV-26-204	Batch disposition	Sterility excursion disposition, Batch 24F-118	Raleigh · Fill/Finish	Maya Chen	Aug 19	Material gaps	IRR-024-118 · Authorization
DRA-024-130	Manual entryBR-24S-130	Batch disposition	Batch 24S-130 released — dissolution at lower specification bound	Cork · OSD	Tom Byrne	Aug 20	Minor gaps	—
DRA-024-131	Uploaded documentII-8841	Supplier exception	Stopper dimensional variance, Lot ST-8841	Supplier Quality	Daniel Ruiz	Aug 21	Material gaps	IRR-024-136 · Draft
DRA-024-134	Manual entryPKG-26-051	Supplier exception	Secondary packaging deviation accepted with 100% inspection	Cork · OSD	Daniel Ruiz	Aug 21	Defensible	—

DRA ID	Decision summary	Five Gap(s)	What is missing	Why it creates reconstruction exposure	Owner	Next action · due	IRR created
DRA-024-109	Visible particulate observed at inspection, Batch 24F-109	Evidence Connection · Decision Reasoning	The inspection result and the isolate-characterisation report are both filed, but nothing records which of them the release decision actually relied on.	An inspector reading the file cannot tell whether the particulate was characterised before or after release was decided.	Alex Morgan	Closed — trend review due Aug 25	Yes · Complete (locked)
DRA-024-112	Media-fill intervention count exceeded procedural limit	Evidence Connection	The acceptance rationale cites "historical media-fill performance" without identifying which runs were examined.	The aseptic-assurance argument cannot be reconstructed without re-deriving the underlying data set from scratch.	Priya Shah	Closed — no further action	Yes · Complete (locked)
DRA-024-115	CAPA-25-338 closed as effective	Evidence Connection · Authorization	Effectiveness evidence is summarised, not referenced; the approver who accepted the closure is not identified in the record.	Closure looks asserted rather than evidenced, and accountability for the closure decision is unattributable.	Alex Morgan	Priya Shah (next-action owner) · confirm trend window covers three campaigns · Aug 25	Yes · Authorization
DRA-024-117	Filter supplier change approved on an equivalence rationale	Decision Reasoning · Risk Judgment	Equivalence is stated as a conclusion. The comparison criteria and the residual-risk threshold that made it acceptable are absent.	A change accepted on unstated criteria cannot be defended if the new filter later underperforms.	Nadia Okafor	Rationale rebuilt in the QMS change record · Closed Jul 14	No — remediated in QMS
DRA-024-122	Fill-line stoppage of 41 minutes during aseptic filling	Decision Reasoning · Evidence Connection	The intervention log excerpt is referenced but not attached, and the link from elapsed time to aseptic-risk conclusion is not written down.	The single most inspected fact — what happened in the line during 41 open minutes — is not evidenced in the decision record.	Priya Shah	Sofia Lindgren (next-action owner) · obtain intervention log excerpt from Manufacturing · Aug 27	Yes · Evidence Review
DRA-024-124	Single-use assembly accepted below nominal gamma dose	Evidence Connection · Alternatives	The dose-mapping report supporting sterility assurance at the lower dose is not cited, and rejecting the assembly was not documented as a considered option.	The record reads as a supply-driven acceptance rather than a risk-based one.	Daniel Ruiz	Decide whether to raise an IRR or reverse the acceptance · Aug 26	No — decision pending
DRA-024-127	Endotoxin OOS retest disposition, Batch 24F-127	Evidence Connection · Decision Reasoning	The lab investigation LAB-26-091 conclusion is not referenced in the disposition, so the basis for invalidating the original result is missing.	An OOS invalidation without a documented laboratory-error basis is the classic 483 observation.	Maya Chen	Reference LAB-26-091 in the record · Aug 26	Yes · Decision Owner Review
DRA-024-118	Sterility excursion disposition, Batch 24F-118	Risk Judgment · Evidence Connection	Residual uncertainty was accepted, but the threshold that made it acceptable — and the monitoring condition it depends on — sat only in meeting notes.	A conditional release whose condition is not part of the record is, on the file, an unconditional release.	Maya Chen	Authorize IRR-024-118 · Due today	Yes · Authorization
DRA-024-131	Stopper dimensional variance, Lot ST-8841	Decision Reasoning · Risk Judgment	The disposition is recorded without connecting the observed variance to the acceptance logic used, and without the residual-risk threshold applied.	Supply continuity is visible in the record; the quality reasoning that permitted it is not.	Daniel Ruiz	Complete IRR-024-136 draft sections · Aug 25	Yes · Draft

IRR ID	Consequential decision	Decision owner	Workflow state	Age / time in state	Current blocker	Next owner · due
IRR-024-118	Sterility excursion disposition, Batch 24F-118	Maya Chen	Authorization	2 days open · 14 h in state	Authorized approver unavailable. Batch remains on hold pending the release decision.	Alex Morgan (delegated approver) · Due today
IRR-024-115	CAPA-25-338 effectiveness-check conclusion	Alex Morgan	Authorization	9 days open · 4 days in state	Approver has asked for confirmation that the effectiveness trend window covers three campaigns.	Priya Shah · Due Aug 25
IRR-024-127	Endotoxin OOS retest disposition, Batch 24F-127	Maya Chen	Decision Owner Review	5 days open · 3 days in state	Laboratory investigation LAB-26-091 conclusion is not yet referenced in the record.	Maya Chen · Due Aug 26
IRR-024-122	Fill-line stoppage deviation disposition	Priya Shah	Evidence Review	7 days open · 6 days in state — stalled against a 2-day target	Intervention log excerpt outstanding from Manufacturing. Third request issued Aug 20.	Sofia Lindgren (Manufacturing) · Due Aug 27
IRR-024-136	Stopper dimensional variance supplier exception	Daniel Ruiz	Draft	Opened today · 6 h in state	Decision reasoning and risk judgment sections not yet drafted.	Daniel Ruiz · Due Aug 25

Linked IRR / decision	Commitment	Owner	Due	Status	Why it matters	Next action
IRR-024-102 · EM trend conclusion (locked)	Requalify the Grade A operator cohort after intervention retraining	Sofia Lindgren	Aug 12	Overdue · 10 days	The environmental-monitoring conclusion accepted residual risk explicitly on the condition that requalification happened before the next campaign. That campaign starts Aug 26.	Escalate to Site Quality Council; confirm a requalification date or reopen the disposition
IRR-024-109 · Visible particulate disposition (locked)	Complete the 30-day stability trend review for lots released under the disposition	Priya Shah	Aug 25	Due soon · 3 days	The release rationale was conditional on the trend confirming no adverse signal. Until it is attached, the conditional basis of a locked record is unsupported.	Attach the trend review output to IRR-024-109 through a controlled amendment
IRR-024-115 · CAPA-25-338 effectiveness check	Confirm effectiveness across three subsequent batches before closure is final	Alex Morgan	Sep 8	On track	Closure was authorized on projected rather than observed effectiveness. The third data point is what makes the conclusion defensible.	Batch 3 data available Sep 4
IRR-024-118 · Sterility excursion disposition	Trend the next three campaigns for the identified location and operator cohort	Maya Chen	Sep 30	On track	Enhanced monitoring is the condition on which the residual risk was accepted. Without it the release rationale does not hold.	Campaign 1 trend due after the Aug 29 fill

Decision · DRA ID	Decision summary	Finding	What is missing from the record	Why it matters · exposure created	Owner	Next action · due	Linked IRR state
DRA-024-109	Visible particulate observed at inspection, Batch 24F-109	Material	The inspection result and the isolate-characterisation report are both filed, but nothing records which of them the release decision actually relied on.	An inspector reading the file cannot tell whether the particulate was characterised before or after release was decided.	Alex Morgan	Closed — 30-day stability trend review due Aug 25	IRR-024-109 · Complete (locked)
DRA-024-112	Media-fill intervention count exceeded procedural limit	Material	The acceptance rationale cites "historical media-fill performance" without identifying which runs were examined.	The aseptic-assurance argument cannot be reconstructed without re-deriving the underlying data set from scratch.	Priya Shah	Closed — no further action	IRR-024-112 · Complete (locked)
DRA-024-115	CAPA-25-338 closed as effective	Material	Effectiveness evidence is summarised rather than referenced — the batches and trend window behind the closure are not identified.	Closure looks asserted rather than evidenced, and cannot be re-tested against the data it was based on.	Alex Morgan	Priya Shah (next-action owner) · confirm trend window covers three campaigns · Aug 25	IRR-024-115 · Authorization
DRA-024-118	Sterility excursion disposition, Batch 24F-118	Material	The monitoring condition the release depends on sat only in meeting notes, so the evidence supporting the residual-risk judgment is not linked to the decision.	The record shows a release; it does not show the evidence that made the release conditional.	Maya Chen	Authorize IRR-024-118 · Due today	IRR-024-118 · Authorization
DRA-024-122	Fill-line stoppage of 41 minutes during aseptic filling	Material	The intervention log excerpt is referenced but not attached to the record.	The single most inspected fact — what happened in the line during 41 open minutes — is not evidenced in the decision record.	Priya Shah	Sofia Lindgren (next-action owner) · obtain intervention log excerpt from Manufacturing · Aug 27	IRR-024-122 · Evidence Review
DRA-024-124	Single-use assembly accepted below nominal gamma dose	Material	The dose-mapping report supporting sterility assurance at the lower dose is not cited anywhere in the disposition.	The record reads as a supply-driven acceptance rather than a risk-based one.	Daniel Ruiz	Decide whether to raise an IRR or reverse the acceptance · Aug 26	No IRR — decision pending
DRA-024-127	Endotoxin OOS retest disposition, Batch 24F-127	Material	The laboratory investigation LAB-26-091 conclusion is not referenced in the disposition.	An OOS invalidation without a documented laboratory-error basis is the classic 483 observation.	Maya Chen	Reference LAB-26-091 in the record · Aug 26	IRR-024-127 · Decision Owner Review

Field	Extracted value	Confidence
Decision type	Investigation conclusion	High confidence
Suggested decision summary	INV-26-221 closed with no root cause determined	High confidence
Decision owner	Tom Byrne	High confidence
Decision date	Aug 4, 2026	High confidence
Source references	INV-26-221 · LAB-26-077 · CAPA-26-011	High confidence
Evidence identified	Laboratory retest summary; equipment maintenance history; operator interview record	Review suggested
Site / function	Raleigh · QC	Review suggested

Spreadsheet column	Workspace field	Status
source_record_id	Source / QMS record ID	Mapped
decision_type	Decision type	Mapped
summary	Decision summary	Mapped
site	Site / function	Mapped
owner	Decision owner	Mapped
decision_date	Decision date	Mapped
qms_link	Source reference (not imported)	Reference only

Source reference	Decision type	Decision summary	Site / function	Decision owner	Decision date
INV-26-158	Investigation conclusion	INV-26-158 root cause assigned to operator technique	Raleigh · Fill/Finish	Maya Chen	Jun 25
DEV-26-119	Deviation disposition	Cleaning hold-time exceeded on Line 2	Cork · OSD	Sofia Lindgren	Jul 6
EMT-Q3-26	Environmental monitoring	Grade A action-limit excursion trended as isolated	Raleigh · Fill/Finish	Priya Shah	Jul 21

Field	Value
Assessment ID	DDA-2026-0418
Assessment type	Decision Defensibility Assessment (self-service, in ComplianceWorxs)
Assessed decision	CAPA-26-011 extended rather than closed
Decision owner	Alex Morgan
Assessment date	Aug 5, 2026
Materiality	Minor gaps — no material reconstruction exposure
Five Gaps found	Decision Reasoning (partial) · Alternatives (partial)
Source / QMS reference	CAPA-26-011 — stays in the QMS