Plain-language definitions for audit, data integrity, and QMS terms — useful when aligning quality visibility and KPI discussions with leadership and IT.
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The FDA regulation that defines when electronic records and electronic signatures are trustworthy and equivalent to paper under predicate rules.
The regulated digital equivalent of a handwritten signature: uniquely attributable to one person, linked to the signed record, captured with meaning and timestamp, and verifiable on inspection.
The regulated process for investigating quality issues, removing their causes, and preventing recurrence across a QMS.
The controlled process for proposing, assessing, approving, implementing, and verifying changes to validated GxP processes, systems, equipment, and documents.
An unplanned departure from an approved procedure, specification, or standard operating practice — the starting point of a GMP investigation.
The regulated process for creating, reviewing, approving, distributing, revising, and retiring controlled GxP documents.
Anything that signals a potential or actual departure from approved processes, procedures, specifications, or regulatory expectations — and the formal entry point into investigation, risk assessment, and CAPA.
A systematic method for identifying the underlying cause of a quality issue — not the symptom — so corrective action can actually prevent recurrence.
The controlled lifecycle that keeps standard operating procedures approved, current, trained, and used at the point of work — the substrate every other GxP control sits on.
The controlled process for qualifying personnel to perform their assigned GxP tasks.
The data integrity framework regulators apply to GxP records.
A secure, computer-generated, time-stamped record of who changed what, when, and why in a regulated quality system.
The periodic, risk-based examination of audit trail records by an independent reviewer, with signed evidence of what was reviewed, what was found, and what was done about it.
The management framework — the policies, roles, and oversight — that turns data integrity from a goal into something a firm can actually sustain.
The assurance that regulated data stays complete, consistent, accurate, and attributable throughout its lifecycle.
The structured process for identifying, assessing, controlling, communicating, and reviewing risks to product quality and patient safety across the product lifecycle.
The structured tool that translates risk principles into comparable scoring across decisions — severity, probability, detectability mapped to action thresholds, calibrated to the firm's specific processes.
Our compliance team can explain how these concepts are implemented in Complere's workflows and validation documentation.
