CAPAs

Who it’s for?

• QAs.
• Approvers.
• CAPA Owners.
• Process Owners.

What it solves?

• Missed due dates.
• Shallow root causes.
• CAPAs that never really close.
• Siloed actions without downstream proof.
• Unclear ownership.
• Access for external users based on configured Event status so the complainant is always informed.
• Complaints that vanish after closure.
• Approval ping-pong: avoid reject→resubmit loops with a Preliminary Reviewer gate.

Key capabilities

• Action types (configurable):
  • User-defined action/task (owner, due date, evidence)
  • Make new document version effective (links to Document Control)
  • Assign training & require completion (links to Training)
• Closure dependencies on actions — define prerequisites, sequence, and required evidence; closure is gated until dependencies are met
• Audit-trail diffs & filters by user/date/action
• No hard deletion: soft-delete & restore; restorations fully logged
• Configurable labels/roles (statuses, investigator/QA/approver)
• External portal access gated by status (read-only updates for complainants or other external stakeholders)
• Versioning with review/approval workflows and e-sign (meaning/intent)
• Your terminology, our controls: configurable status & role names.
• Effectiveness checks with success criteria & time windows

Compliance

• Approvals with meaning.
• Trails across linked records.
• No hard deletion of records and on demand restoration of deleted records.
• Strong audit trails.

Audit ease

• Time-stamped, immutable audit trails with a clean, side-by-side diff so you can compare any two versions and see who changed what, when, and why.
• Side-by-side version compare.
• Chronology timeline + field-level diffs; jump to linked Quality Event/Controlled Change/Documents.
• Inspection Pack (timeline, investigation summary, actions, dependencies, effectiveness) + notification log and diffs.