Level 3: Managed
Structured, proactive, inspection-ready.
You run a structured, inspection-ready quality system. To advance, instrument your processes with metrics and trending so decisions are evidenced by data rather than judgement alone.
What a level is not
The five levels are SPEQ’s progression, labelled synthesis. They are not the FDA’s Quality Management Maturity rating scale, no regulator assigns them, and reaching one is not a compliance status.
A quality system rarely sits at one level everywhere. This is the character of each of the twelve GxP domains when it is operating at Level 3 — and the move that lifts it to the next.
Formal change control with real impact assessment and approval before implementation; documents are reliably current.
TO ADVANCE →Instrument the system — trend change volume, lead time, and overdue actions so management review acts on data.
Root cause is taken seriously, effectiveness checks are real, and risk decides investigation depth (ICH Q9).
TO ADVANCE →Trend CAPA metrics and feed them to management review so the system is steered by data.
A risk- and science-based V&Q lifecycle is in place; the control strategy is understood and maintained.
TO ADVANCE →Instrument the process — trend Cpk and CPV so drift is seen before a batch fails.
A risk-based EM program feeds a contamination control strategy; excursions are investigated in context.
TO ADVANCE →Trend EM data so shifts in the state of control are detected before an excursion.
Systematic horizon scanning feeds a defined impact-assessment and action process.
TO ADVANCE →Move from reacting to changes to proactively gap-analysing against upcoming requirements.
Risk-based quality management (RBQM) focuses oversight on critical-to-quality factors.
TO ADVANCE →Add centralised/statistical monitoring so signals are detected across sites, not one visit at a time.
A compliant GLP system runs with independent QA and controlled archives.
TO ADVANCE →Trend QA findings and laboratory data so systemic issues surface across studies.
Qualified lanes and containers with monitored conditions; excursions are assessed against defined criteria.
TO ADVANCE →Trend excursion and lane performance so weak links are fixed before they fail.
Systematic signal management runs alongside compliant case processing and a current PSMF.
TO ADVANCE →Add signal and safety metrics so benefit-risk is managed proactively.
ALCOA+ controls are in place across critical systems with routine, risk-based audit-trail review.
TO ADVANCE →Trend audit-trail-review findings and data-integrity events so systemic weaknesses surface.
Science- and risk-based C&Q focuses verification on what affects product and patient.
TO ADVANCE →Trend verification and system-reliability data so engineering learns across projects.
It is observably safe to raise problems; stop-the-line authority is real and Just Culture is applied.
TO ADVANCE →Measure the culture — track speak-up rates and near-miss reporting so leaders steer it with data.