Verrion Systems · Pharma Compliance Suite · www.verrionsystems.com · Every record shown is illustrative and uses a synthetic scenario.

Deviation, CAPA and SOP review software

For UK pharmaceutical quality teams: link deviation facts, investigation, disposition and CAPA, or review procedures against their sources. The people accountable keep every decision.

A line operator in a blue coat and hairnet, checking a tablet beside packaging equipment. Behind her, an amber warning light is on.

Deviation record DEV-0417

Illustrative · synthetic scenario

Deviation Companion · Initial facts

Observation: Fill weight below target on three in-process checks Reporter · 10:52
Affected scope: Line 3 · Batch B-0417 · from 10:40 Batch review
Supporting material: Batch-review printout and check-weigher data Line records
For the investigator: Was anything adjusted before 10:40? Reporter · open question

Reviewed draft ready for the investigator

What was seen. What can be shown.

Each claim is traced back to what was recorded.

Where evidence is missing, the gap stays visible.

A tablet, a procedure binder and packaging equipment at the line where the deviation was noticed.

Investigation DI-0417

Illustrative · synthetic scenario

Deviation Investigator · Causal review

Proposed cause Open to challengeReview again

Fill-weight drift after a changeover adjustment at 10:40.

Batch record shows an adjustment at 10:40Supports
Three in-process checks below target after itSupports
Procedure requires a check after changeoverRequirement
Equipment adjustment record provided

Select the missing record to mark it as provided.

Human decision. The investigator records the conclusion. Authorised reviewers complete the review and approval.

AI can assist with selected analysis and drafting after the applicable data review. People own the outcome.

Beside the packing line, a stretch-wrapped pallet of cartons, taped off and labelled HOLD. On the machine behind it, a red warning light is on.

Affected material waits.

While the cause is investigated, Site QA decides what happens to each affected group.

Impact & Disposition ID-0417

Illustrative · synthetic scenario

Continues from linked record DI-0417

Affected groups, interim controls and recorded outcomes
Affected group	Units	Interim control	Outcome
Packed after 10:40	12,400	Quarantined	Reject Signed · Site QA, QP
Packed before 10:40	18,000	Held for review	Release after added checks Signed · Site QA, QP
Total	30,400	Full quantity reconciled

Site QA owns this DI-linked disposition review and its approvals. Impact & Disposition uses no AI.

A line lead in a blue coat working on a laptop beside packaging equipment.

The action leaves the record, and comes back with evidence.

An agreed action stays linked to its source, its owner, the evidence of what was done and the check that it worked.

CAPA CAPA-0212

Illustrative · synthetic scenario

Source: DI-0417 · Corrective action

Action: Add a weight verification after every changeover adjustment.
Owner: Packaging line lead, named in the record
Implementation evidence: Updated changeover checklist and training record Line lead
Effectiveness check: No fill-weight deviations linked to changeovers across the next 20 batches In progress
Review and closure: Independent Quality reviewers decide whether to accept and close

A handoff does not create or close a CAPA automatically.

Pharma Compliance Suite

One workflow. Four records, each with its own owner.

Capture facts with Deviation Companion, investigate causes with Deviation Investigator, manage affected items with Impact & Disposition, and review corrective or preventive actions with CAPA. Display order is not a compulsory sequence.

Capture the factsDeviation Companion

Capture the event, complete the factual details and prepare a reviewed draft for the investigator.

Starts with: Initial facts and supporting material
Owned by: Reporter and assigned investigator
Produces: A reviewed intake and evidence package

Formal investigation and its approvals remain in Deviation Investigator.

Illustrative record DEV-0417

Investigate the causeDeviation Investigator

Examine the event, test the proposed cause against the evidence and record the reviewer’s rationale.

Starts with: Event facts and supporting evidence
Owned by: Investigator and authorised reviewers
Produces: A reviewed investigation record

Root cause, actions and approval remain human decisions.

Illustrative record DI-0417

Manage affected itemsImpact & Disposition

Impact & Disposition continues directly from a linked Deviation Investigator record. Site QA manages affected quantities, interim controls and signed outcomes in its workspace.

Starts with: A linked DI record, affected items, quantities and controlled evidence
Owned by: Site QA, with applicable QP/QMR sign-off
Produces: Recorded disposition outcomes, reconciled quantities and decision history

Site QA owns disposition decisions and approvals. I&D uses no AI.

Illustrative record ID-0417

Follow actions throughCAPA

Keep each corrective or preventive action connected to its source, owner, implementation evidence and effectiveness review.

Starts with: An action and its traceable source
Owned by: Action owners and independent Quality reviewers
Produces: Actions with retained implementation and closure evidence

CAPA manages the action lifecycle. It does not repeat the investigation or decide product disposition.

Illustrative record CAPA-0212

Two colleagues in white coats discussing a procedure shown on a tablet.

A closer look at the procedure.

The SOP workflow is separate from the deviation workflow. SOP Intelligence compares documents and shows the source behind each finding.

Procedure under review SOP-QA-031

Illustrative · synthetic scenario

SOP Intelligence · Line clearance between batches

3.2A second person verifies the line is clear before the next batch starts.

4.1Remove all materials, labels and documents from the previous batch.

5.1The supervisor confirms clearance once the area has been inspected.

5.4Photograph the cleared line for the batch file.

Select a finding to highlight its source.

Starts with: Selected documents and a review purpose
Owned by: SOP owners and authorised reviewers
Produces: Reviewable findings linked to their sources

Document ownership, change control and approval remain with your authorised process.

Before we talk.

A few practical questions.

What can we pilot?

Choose the Deviation/CAPA workflow or the SOP workflow. We agree the scope and availability for your chosen pilot.

Pilots are scoped and priced per site. They run on synthetic or customer-approved data within agreed boundaries. Contact hello@verrionsystems.com to discuss.

Where does AI fit?

AI can assist with selected analysis and drafting tasks after the applicable data review. Authorised people review the output and own the decisions. Impact & Disposition uses no AI.

What would a walkthrough cover?

We start with your quality workflow, then explore the relevant modules, who reviews the records and what evidence they need. A pilot can use synthetic or customer-approved scenarios within agreed data boundaries.

A QA representative and a line operator reviewing an investigation together on a laptop beside packaging equipment.

Let’s look at the work together.

Walk through the PCS modules relevant to your team’s deviation investigations or procedure reviews.

Arrange a walkthrough for

Please leave regulated and confidential material out of your first message.

hello@verrionsystems.com · www.verrionsystems.com