Inputs
Review inputs assembled from live data
Open and overdue actions, quality-event trends, audit findings, and training compliance come straight from module dashboards — not from slides rebuilt by hand.
Platform Capability
Management Review
Inputs from live data, minutes as controlled records, outputs tracked to closure.
Management review used to be the meeting whose records FDA would not ask for. That changed on February 2, 2026 — under the QMSR inspection program, management review records are reviewable. Complere treats management review as governed quality work: Dashboards & KPIs assemble the inputs ISO 13485 §5.6 expects, Document Control holds the agenda and minutes as signed, versioned records, and review outputs route into CAPA and Change Control where they are tracked to closure — all under one audit trail.
Key Benefits
How governed management review reduces compliance risk and supports inspection readiness for regulated teams.
Records
Minutes are controlled, signed documents
Agendas, minutes, and attendance live in Document Control with versioning and electronic signatures — an inspectable record, not a meeting note in someone's drive.
Closure
Outputs tracked to closure
Decisions become CAPA or change records with owners and due dates — so the next review opens with the status of the last review's actions, evidenced.
How Complere supports the workflow
Each step is supported by governed records, electronic signatures, and a full audit trail — so the review cycle stays traceable and inspection-ready.
01
Set the cadence and agenda
Review frequency and standing agenda are governed documents — the cadence itself is evidence of a functioning quality system.
02
Assemble inputs from module dashboards
CAPA status, quality-event trends, audit findings and closure, training compliance, document and change backlog — pulled from the system of record.
03
Run the review, sign the minutes
Minutes and decisions are captured as a controlled document with electronic signatures — attributable, time-stamped, and version-controlled.
04
Route outputs and track to closure
Improvement decisions become CAPAs or controlled changes with owners and due dates — so the next review opens with the evidenced status of the last review's actions.
Built for the QMSR inspection era
What changed on February 2, 2026 — and what it means for this record set.
Then
Under QSIT: off-limits
FDA's longstanding policy was not to request records of management reviews — many teams ran them as informal leadership meetings.
Now
Under CP 7382.850: reviewable
The QMSR-era compliance program eliminated the exemption. Cadence, inputs, minutes, and resulting actions are now within an investigator's reach.
Ready
Retrieval, not reconstruction
Because the inputs, minutes, and outputs already live in governed modules, producing the record set is a retrieval task — see the QMSR transition hub.
Frequently asked questions
How management review works in Complere — honestly framed.
Is management review a separate Complere module?
No — and that is deliberate. Management review in Complere is a governed practice assembled from the modules that already hold the evidence — Dashboards & KPIs supply the inputs (CAPA status, audit findings, training compliance, quality-event trends), Document Control holds the agenda and minutes as controlled, signed documents, and review outputs are routed into CAPA and Change Control where they are tracked to closure. One audit trail covers the whole cycle.
Why does management review matter more under the QMSR?
Under the former QSIT inspection approach, FDA policy was not to request management review records. The QMSR-era compliance program (CP 7382.850, effective February 2, 2026) eliminated that exemption — investigators can now review management review records. Cadence, inputs, minutes, and resulting actions per ISO 13485 §5.6 must be complete, current, and retrievable.
What inputs does Complere assemble for a management review?
Live dashboard views across modules — open and overdue actions, quality-event trends, internal and supplier audit findings with closure status, training compliance including overdue training, and document and change backlog. The same KPI views leadership uses day to day become the review inputs, so nothing is rebuilt by hand for the meeting.
How are management review records produced for an inspection?
The agenda and minutes live in Document Control as controlled documents with versioning and electronic signatures; decisions and actions are routed into CAPA and Change Control with owners and due dates; and every step carries the platform audit trail. Producing the record set for an investigator is a retrieval task, not a reconstruction project.
Make your next management review an inspectable record
See how review inputs, controlled minutes, and tracked outputs come together in one governed cycle.