Invariant eQMS Roadmap

Hand work to people outside quality and still close the loop. Direction: QA assigns a task to someone in another department, the assignee marks it done, and QA verifies it before it closes. This builds on the existing quality task tracker and quality request tickets.

Fit the approval path to your team, including when your scope changes, without rebuilding the workflow. Direction: choose who must approve at each stage of a deviation, CAPA or change control, per organization. The lifecycle and its closure steps stay fixed so every record still closes properly; what changes is who signs at each step. Update, 3 November 2026: change controls can now name their approvers, where enabled for your organization: up to 25 people, each with a function and marked required or optional, plus one required final QA approver. Still to come: the same for deviations and CAPAs.

Track more of the quality events regulated producers manage, in the same format and closure spine as deviations and CAPAs. Direction: record types for product recall, loss and theft, and continuous-improvement initiatives. Tell us which other event types your current system holds.

Put a complaint in proportion: record the units affected against the units released for the lot, show the percentage, and flag it when a threshold your organization sets is crossed.

Make the decision not to investigate as visible as the decision to investigate. Direction: each complaint carries a recorded triage outcome (investigation required, or no investigation warranted) with the rationale and the person who approved it.

When several complaints share a cause, investigate once. Direction: Link multiple complaints to one investigation or CAPA Attach later complaints to an investigation that is already closed, recorded as covered by it Today a complaint can be linked to existing deviations and CAPAs one record at a time.

Capture the health-effect details a regulator expects (symptoms, onset, severity, medical attention sought, reporter type, report date and reference) on a complaint and export the report. A customer-service intake role can log complaints and see their status without seeing the investigation.

Handle an out-of-specification result as an OOS investigation, not as a general deviation. What we are working through: A laboratory-phase investigation that rules out analytical error before any manufacturing-phase investigation begins Defined retest and re-sampling steps, with the authorisation for each recorded An explicit, signed decision on whether the original result is invalidated, and on what grounds Links to the batch or lot affected and to any deviation or CAPA that follows Why this matters: an OOS has a specific expected shape, and a reviewer who finds one recorded as an ordinary deviation will notice that the lab-phase investigation and the invalidation decision are missing. This matters most for operators doing release testing against an importing country's requirements, where an OOS holds a shipment. Update, 3 November 2026: now live where enabled for your organization: the original result, frozen at first submission; a Phase I laboratory investigation with five checks; independent, password-reverified review or return; attachments; Phase I due dates on the calendar with reminders; a record PDF; and links to a follow-up deviation or CAPA. Still to come: retest and re-sampling steps, the signed invalidation decision and the manufacturing-phase investigation.

Score the risk of an issue when you open a CAPA, then score it again once the corrective action has been done — so the record shows whether the risk actually came down. What we are aiming at: Severity, occurrence and detectability scored on a scale your organisation sets, producing a single risk number An initial score at CAPA opening and a re-score at effectiveness verification, with the change shown on the record Both scores included in what gets signed, so the numbers are part of the signed record rather than editable afterwards Risk scores that can be trended across your whole CAPA programme, not just read one record at a time Why this matters: quality managers tell us that an effectiveness check written as a paragraph asks an auditor to take your word for it, while a before-and-after score shows the improvement as a measurement. It also makes effectiveness something you can trend across a programme rather than something you re-read case by case. Update, 3 November 2026: now live where enabled for your organization: an initial risk score when the CAPA opens and a residual score once the actions are complete, using severity, occurrence and detectability on a 1 to 10 scale. The CAPA shows both scores and the reduction, and keeps an append-only history. Still to come: a scale your organization sets, the scores inside the signed record, and trends across the CAPA programme.

Visualize a deviation, complaint, or change control as a parent timeline with its linked CAPAs and change controls nested beneath — each with its own dates and progress. See dependencies at a glance and get flagged when a sub-task's timeline runs past its parent's due date, so management can see exactly where multi-step investigations stand. Update, 3 November 2026: now live where enabled for your organization: a deviation timeline with its CAPAs, actions, change controls and tasks nested beneath, flagging any item that runs past its parent's due date. Still to come: timelines that start from a complaint or a change control.