Storyline Timeline

The Storyline Timeline shows the complete history of quality events in chronological order. It connects documents, deviations, CAPAs, audits, version changes, and signatures into a unified narrative, making it easy to trace event lifecycles and their relationships.

---

View the timeline

The timeline displays events as a vertical list of cards. Each event card shows:

• Event icon with a colored background
• Event title — the action that occurred
• Type badge — identifying the module
• Severity badge (when applicable) — Low, Medium, High, or Critical
• Priority badge (when applicable)
• Description, actor, status, and timestamp

Event type icons

Icon	Type	Description
Document	document	Document creation, updates, approvals
Warning	deviation	Deviation reports and resolutions
Tool	capa	CAPA creation, actions, effectiveness reviews
Search	audit	Audit scheduling, findings, closures
Clipboard	version	Document version changes
Pen	signature	Electronic signature events

---

Filter events by type

1. Above the timeline, locate the event type filter buttons.
2. Select an event type button to toggle it on or off.
3. Select multiple types to show events matching any of the selected types.
4. When no filters are active, all events are displayed.
5. Select Clear All to remove all active filters.

---

Sort events

1. Select the sort button above the timeline.
2. Toggle between:
   • Chronological — oldest events first
   • Reverse — newest events first (most recent at top)

---

Expand event details

1. On an event card with additional metadata, select Show Details.
2. A details panel expands showing all metadata key-value pairs in a two-column grid.
3. Select Hide Details to collapse the panel.

---

Review summary statistics

At the bottom of the timeline, four summary cards show total counts:

Card	Description
Documents	Total document-related events
Deviations	Total deviation-related events
CAPAs	Total CAPA-related events
Signatures	Total signature-related events

Tip

The Storyline Timeline is particularly useful during audit preparation. It provides auditors with a complete narrative showing how deviations led to CAPAs, which drove document changes, all verified with electronic signatures.

Note

The Storyline Timeline is also used within the External Auditor Access portal, where it provides external auditors with a compliance summary, risk assessment, and event chronology for the audit scope.

---

Practical example: Reviewing a document’s compliance history

Scenario: During an FDA inspection, an auditor asks to see the full history of how a critical sterilization SOP evolved in response to quality events over the past year.

1. Open the Storyline Timeline for document SOP-1087 “Ethylene Oxide Sterilization Process.”
2. Set the sort order to Chronological (oldest first) to tell the story from beginning to end.
3. The timeline shows the following sequence of events:
   • Jan 15 — Document event (green): “SOP-1087 v2.0 approved” with signatures from QA Manager and Production Director.
   • Mar 8 — Deviation event (orange): “DEV-612: Incomplete EO aeration cycle detected” — Severity: High. The event card shows the deviation was discovered during routine batch record review.
   • Mar 12 — CAPA event (red): “CAPA-298: Revise aeration hold time and add continuous monitoring” created in response to DEV-612.
   • Apr 2 — Document event (green): “SOP-1087 v3.0 draft created” — incorporating revised aeration parameters from CAPA-298.
   • Apr 18 — Signature event (blue): “SOP-1087 v3.0 approved” with e-signatures from QA, Production, and Regulatory Affairs.
   • May 5 — CAPA event (red): “CAPA-298 effectiveness review completed” — confirmed no recurrence of incomplete aeration cycles in 10 consecutive batches.
   • Jul 22 — Audit event (purple): “Internal Audit AUD-045: Sterilization process controls” — Finding: compliant, no observations.
4. Select Show Details on the CAPA-298 effectiveness review to see the metadata: 10 batches reviewed, 0 recurrences, effectiveness rating “Effective.”
5. Filter the timeline to show only deviation and capa events to isolate the quality issue and its resolution for the auditor.
6. Review the summary cards at the bottom: 3 document events, 1 deviation, 2 CAPA events, 2 signature events.

The auditor can now see a clear, traceable narrative: a deviation was identified, a CAPA was opened, the SOP was revised, the revision was formally approved with electronic signatures, effectiveness was verified, and an internal audit confirmed the controls are adequate.