Controlled Change — Govern changes without chaos
Who it’s for?
- Process Owners.
- Engineering.
- QAs.
- Approvers.
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.
