Regulatory and validation

Backlog triage

Rank open deviations, CAPAs, change controls, complaints and findings by risk with the reason for each flag; QA sets every priority and signs the order to work the queue.

In the portal: /app/backlog

The triage procedure

Backlog triage
  1. Person

    1. Load the backlog

    Paste or attach an export, or pull open QLogix records

  2. AI drafts

    2. Rank by risk

    Score 0 to 100, flags with quotes, patterns

  3. Person

    3. Set the QA priority

    Confirm or change each

  4. Person

    4. Remove or add items

    With reasons

  5. Person

    5. Record the decision

  6. E-signature

    6. Review and approval

Load and rank

  1. Step 1: Open Backlog triage and choose New triage. Give it a name and the as-of date.
  2. Step 2: Paste the backlog (a CSV with a header row is read row by row; free text is read by the AI), attach exports, KPI reports or your escalation procedure, and tick Include the open … already in QLogix to pull open records from every product. Up to 150 items.
  3. Step 3: Keep Rank the backlog now ticked and choose Create and rank.
PriorityScoreWeighed, in order
Critical80 to 100Patient or product impact (Grade A/B, product on hold or distributed)
High55 to 79Regulatory exposure, data integrity, inspection commitments
Medium30 to 54Recurrence, due dates, age against cycle times (age alone gives Medium at most)
Low0 to 29The organization's own classification; closed items to confirm and remove

QA priorities and decision

  • Sort the Queue by oldest first, AI rank or QA priority. For each item confirm the AI's priority or set another with a reason; add an owner and next step note.
  • Remove from the backlog (closed elsewhere, duplicate, not a record) or Restore with a reason; Add an item the sources missed.
  • Read Patterns across the backlog for clusters and recurrence.
  • Record the decision: Priorities approved: work the queue in this order, Escalate the critical items to management review, or Re-triage after the backlog data is corrected.

Before routing: the backlog ranked, at least one active item, a QA priority on every active item, and the decision recorded.