The language of quality, in plain language.

Electronic Quality Management System — software that runs a regulated organization's quality processes (documents, training, CAPAs, deviations, audits) as one controlled, auditable system instead of paper and spreadsheets.

Corrective and Preventive Action — the structured response to a quality problem: find the root cause, fix it, prevent recurrence, and verify the fix actually worked before closing.

Any departure from an approved procedure, specification, or expected result. Regulated teams must capture, assess, investigate, and resolve them — with records at every step.

The FDA rule governing electronic records and electronic signatures: signatures must be attributable and bound to their record, audit trails secure, and access controlled.

The data-integrity yardstick: records must be Attributable, Legible, Contemporaneous, Original, and Accurate — plus complete, consistent, enduring, and available. Inspectors test against it.

Installation, Operational, and Performance Qualification — the documented proof that a system is installed correctly, works as specified, and performs reliably in your real use.

The tamper-evident history of every create, change, sign, and view on a record — who, what, when, and why. Append-only by construction, not by policy.

The gate every significant change passes through: impact assessed across documents, training, and validation; approvals routed; an effectivity date set; the change verified after the fact.

Keeping one — and only one — effective version of every SOP, policy, and form in circulation: versioned, approved by e-signature, distributed to the right people, obsolete copies locked out.

The family of 'good practice' regulations — GLP (laboratory), GCP (clinical), GMP (manufacturing) — that govern quality across the life-sciences lifecycle.

The form FDA investigators issue at the end of an inspection listing observed violations. Unaddressed, observations can escalate to a warning letter.

The scheduled follow-up that proves a corrective action worked — the difference between a CAPA that's closed and one that's merely filed. A missing one is a classic audit finding.

The quality-management standard for medical devices — design controls, document and record control, and post-market feedback, audited by notified bodies.

The US clinical-lab regulatory pair: CLIA sets federal requirements for testing quality and personnel competency; CAP accreditation layers detailed checklist requirements on top.

The scheduled re-examination of a controlled document to confirm it still matches practice and regulation — with evidence the review happened, not just a calendar entry.

The documented assessment that a vendor can reliably meet your quality requirements — scored, time-limited, and renewed on a schedule with re-evaluation.

The multi-rule decision system for judging QC runs — patterns like 1-3s and 2-2s that distinguish random noise from real analytical error, so runs are held for cause, not habit.

The control chart of QC results over time against mean and SD limits — the at-a-glance view of whether a method is drifting, shifting, or in control.

Design History File — the compiled record of a medical device's design controls: inputs, outputs, reviews, verification, and validation. Assembles itself from linked records, or from a folder scramble.

The unbroken, signed link between a patient and their cell or tissue product across every custody handoff — the non-negotiable record in autologous therapy.

The date a change or document revision takes effect. Before it: the old version rules. After it: the old version is locked out and affected staff are trained. Set deliberately, under change control.

Standard Operating Procedure — the approved, versioned instruction for how a regulated task is performed. The document inspectors compare against what they watch your team actually do.

The industry framework for validating computerized systems, scaled by risk and software category — the reason configured systems validate in weeks while custom ones take quarters.

The European GMP rules for computerized systems — the EU counterpart to Part 11, covering audit trails, access, validation, and data integrity for electronic records.

The documented, periodic proof that a person can actually perform the testing they're assigned — under CLIA, six defined elements on a fixed cycle, semiannual in year one.

A calibration result outside acceptable limits. The finding isn't the OOT itself — it's failing to assess the impact on every result the instrument produced since it was last known good.

The structured investigation past the first convenient answer. 'Operator error' is where an RCA starts, not where it ends — the cause you fix must explain why the error was possible.

Blind external samples tested alongside patient work to prove your results agree with the field. Failures require documented investigation and corrective action — and regulators see the scores.