64 terms across 6 categories. Every acronym and concept used across the platform — ALCOA+, Part 11, autonomy classes, GAMP 5, CDISC, RAG, and more.
FDA regulation governing electronic records and electronic signatures. Every regulated promotion on this platform passes through a Part 11 gate: re-authentication, stated intent, and an immutable signature row.
See also: ALCOA+, GxP, E-signature, FDA
Data must correctly represent what was observed. The platform enforces this via citation grounding on authoring agents and reviewer sign-off before promotion.
See also: ALCOA+, Citations
The FDA / MHRA data-integrity framework. Every regulated write on this platform carries the metadata needed to satisfy all nine pillars. See each pillar entry for what it means in practice.
See also: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available
Every record must identify who created it. The platform records created_by, signed_by, and a full provenance_event chain for every regulated write.
See also: ALCOA+, Provenance
Data must be retrievable on demand throughout the retention period. Inspection-ready exports are produced from the provenance store and signature events.
See also: ALCOA+
All data, including repeats and reanalyses, must be retained. The platform never deletes provenance rows; corrections are recorded as new events with links to the original.
See also: ALCOA+, Provenance
Records must follow the same sequencing and use synchronized, traceable timestamps. The platform timestamps every event in UTC (timestamptz) and orders by the database clock.
See also: ALCOA+
Records must be created at the time of the activity. Agent actions write provenance events synchronously; signatures capture the wall-clock signing time, not the action time.
See also: ALCOA+
The Part 11 act that promotes a staged record to live. Requires re-authentication, an explicit stated intent, and writes an immutable signature row referencing the action.
See also: 21 CFR Part 11, Staging
The European Union regulator for human and veterinary medicines. Counterpart to the FDA; relies on the same ICH-GCP framework.
Records must persist for the full regulatory retention period (often 25+ years). Provenance and signature rows are append-only and backed up off-site.
See also: ALCOA+
The FDA database of post-market adverse event and medication error reports. ICSRs about US-marketed products typically flow into FAERS via E2B(R3).
The U.S. regulator for drugs, biologics, and devices. Issues 21 CFR Part 11, GxP guidance, and the CSA framework. Inspections are the headline risk this platform is built to survive.
See also: 21 CFR Part 11, EMA, GxP, CSA
The ICH E6 international standard for designing, conducting, and reporting clinical trials. Applies to every study this platform supports.
The quality system for non-clinical laboratory studies (typically toxicology). Sibling of GCP and GMP under the GxP umbrella.
The quality system for drug and device manufacturing. Not the platform primary scope, but cross-references appear in supply chain and IMP handling.
Collective term for the regulated quality systems: GCP, GLP, GMP, GVP, etc. Any system that touches GxP data must be validated and Part 11 compliant.
See also: GCP, GLP, GMP, 21 CFR Part 11
The harmonized GCP guideline (ICH E6) adopted by FDA, EMA, PMDA, and others. The reference framework for every interventional study on this platform.
A structured report of one adverse event for one subject. Transmitted to regulators (FDA via FAERS, WHO via VigiBase) using the ICH E2B(R3) format. AI never makes the causality call.
Records must be readable and permanent. Stored as structured JSON in Postgres with human-readable rendered views in the inspection package.
See also: ALCOA+
Records must be the first capture, or a verified true copy. Staging carries the original proposal; promotion produces a true copy bound to the signature.
The discipline of detecting, assessing, and preventing adverse effects of medicinal products. The platform supports PV authoring but never determines causality.
The World Health Organization global database of suspected adverse drug reactions, maintained by the Uppsala Monitoring Centre. Counterpart to FAERS.