Regulated writing, defined.

An append-only record of every drafting action — retrieval, generation, revision, source version, model version — that produced a document. In Asthra, the ledger embeds in the .docx and travels with the file. See Trust center.

Periodic safety document submitted to regulators — covers PSUR, PBRER, DSUR, and ACO formats. Synthesizes safety data accrued during a defined reporting interval.

Contract required under HIPAA when a vendor handles protected health information on a covered entity's behalf. Asthra signs BAAs for HIPAA-bound deployments.

QC mode where citations are hidden from a reviewer until they explicitly request the source. Used to test whether a passage holds up on its narrative merits before provenance is examined.

Document required under EU MDR demonstrating clinical safety and performance of a medical device. Built around a literature search, appraisal, and synthesis of clinical data. See Asthra for CER.

A typed, queryable structure linking every assertion in a draft to its supporting source passage(s). Asthra's graph is two-level — section and sentence — and exposed via the Word add-in and an export API.

Default architectural property: the drafting agent has no unattended path to external sources. Evidence comes from a customer-managed source set. Internet retrieval requires explicit writer approval per lookup and is recorded in the audit ledger. Foundational to Asthra's hallucination control.

The Module 3 portion of a regulatory submission covering drug substance, drug product, and manufacturing controls. See Asthra for CMC.

An ICH E3-structured document describing the design, conduct, and results of a clinical trial. Typically the longest document in a regulatory submission. See Asthra for CSR.

The harmonized format for regulatory submissions across ICH regions. Five modules; Module 3 covers CMC.

Annual safety report for investigational drugs in development, governed by ICH E2F. One of the document types Asthra supports under aggregate safety reporting.

European regulation classifying AI systems by risk tier and imposing obligations on high-risk deployments. Asthra is deployed and documented as a high-risk AI system.

The electronic repository of essential clinical trial documents. Asthra ingests sources from common eTMF systems via API.

Inline marker generated when source data needed for a section is missing, contradictory, or out of scope. Recorded in the audit ledger so reviewers see exactly which areas need additional sourcing.

Umbrella term for regulated practices: GMP (manufacturing), GLP (laboratory), GCP (clinical), GVP (pharmacovigilance), GDP (distribution). Tools used in GxP-bound workflows must be validated.

Workflow pattern requiring human review at defined points. Necessary but not sufficient — Asthra augments HITL with gated approvals and recorded decisions in the ledger.

Body that publishes harmonized technical guidelines across major regulators. Asthra encodes ICH E3 (CSR), E2C/E2F (safety), and M4Q (CMC) as module-specific writing rules.

U.S. regulatory submission types: Investigational New Drug, New Drug Application, Biologics License Application. CSRs, CMC, and safety reports feed into all three.

Stage of CER drafting where retrieved literature is screened, scored against inclusion criteria, and synthesized. Asthra surfaces the appraisal map alongside the draft.

EU 2017/745, the regulatory framework for medical devices in the EU. Drives CER content and update frequency.

European guidance on clinical evaluation. Specifies the structure and rigor expected in a CER; encoded in Asthra as the CER module rule set.

An organization designated by an EU member state to assess medical-device conformity. Reviews CERs and technical documentation as part of CE-marking.

ICH E2C(R2) format for post-marketing periodic safety reporting. Replaced PSUR for many regions; the names are often used together.

The traceable lineage of a claim — which source, which version, which retrieval, which generation. Asthra treats provenance as a first-class data structure rather than a side-effect.

Aggregate safety report submitted to regulators on a defined cadence. See Asthra for PSUR / PBRER.

EU-required role responsible for the pharmacovigilance system of a marketing authorization holder. Approves aggregate safety reports.

Generic pattern of grounding LLM output in retrieved documents. Asthra's closed-system retrieval is a stricter, regulation-aware variant — see Compare.

AICPA framework for service-organization controls covering security, availability, processing integrity, confidentiality, and privacy. Asthra is SOC 2 Type 1 ready, Type 2 in progress.

The bounded collection of customer-supplied documents that Asthra is allowed to retrieve from for a given project. Defines the universe of fact for that draft.

Transport-layer encryption standard used for all Asthra traffic in transit, including Word add-in to backend.

Asthra's provenance model: every section is cited at the document level by default, and every sentence carries a sentence-level citation surfaced on demand.

Documentation bundle (URS, IQ, OQ, PQ, traceability matrix) that supports installation qualification of Asthra in a GxP environment. Available on request for Part 11-bound deployments.

Deployment in which Asthra runs entirely inside the customer's cloud account (AWS / Azure / GCP). Source documents and drafting traffic stay in-tenant.