Bioscience QMS Work Order System — Comprehensive Glossary
Classification: Internal — Reference
Date: 2026-02-13
Version: 5.0 (comprehensive — all terms from all 79+ artifacts + system prompt v8, alphabetized A→Z)
Scope: Every acronym, technical term, and domain concept appearing across all markdown artifacts, JSX dashboards, ADRs, meta-prompts, and specification documents
A
| Term | Definition | CODITECT Equivalent | Ecosystem Analogs |
|---|---|---|---|
| ABAC | Attribute-Based Access Control — access decisions based on attributes of user, resource, and environment | Future RBAC extension | Azure ABAC, AWS IAM policies |
| ACI | Agent-Computer Interface — Anthropic principle that tool design for AI agents deserves equal investment to HCI | Tool Engineering principle | Anthropic agent guidelines |
| ACID | Atomicity, Consistency, Isolation, Durability — transaction properties guaranteed by PostgreSQL | Database transaction model | SQL standard |
| ACV | Annual Contract Value — average annual revenue per customer contract; target $240K at maturity | Revenue metric | SaaS ACV |
| ADR | Architecture Decision Record — structured document capturing architectural decisions with context, alternatives, consequences | adrs/ artifact collection | MADR, Nygard ADR format |
| AES-256 | Advanced Encryption Standard (256-bit key) — symmetric encryption for data at rest in PostgreSQL TDE | Encryption configuration | NIST standard |
| Agent Message | Typed data structure routed between agent nodes via Event Bus with payload, correlation ID, and metadata | AgentMessage interface | LangGraph StateMessage, Temporal Signal |
| Agent Session ID | Unique identifier for a CODITECT agent execution trace, linking audit entries to specific agent runs | AuditTrail.agentSessionId | OpenTelemetry Trace ID |
| AICPA | American Institute of Certified Public Accountants — defines SOC 2 Trust Service Criteria | Compliance standard body | — |
| API | Application Programming Interface — contract defining component communication; CODITECT uses REST + events | API Gateway layer | OpenAPI 3.1, gRPC, GraphQL |
| Approval | Formal decision record (APPROVED/REJECTED) linked to an electronic signature for Part 11 compliance | Approval entity | ServiceNow Approval, Veeva eSignature |
| Approval Chain | Ordered sequence of required approvals; regulatory WOs need System Owner + QA; tenant-configurable | Compliance Engine config | Veeva Approval Workflow |
| Approval Gate | Mandatory checkpoint requiring human e-signed approval before state advancement; database-enforced | Checkpoint Manager | Temporal Activity |
| ARR | Annual Recurring Revenue — total annualized subscription revenue; Y3 target $28.8M | Revenue metric | SaaS ARR |
| ARPU | Average Revenue Per User — revenue divided by active user count | Revenue metric | SaaS ARPU |
| Asset | Physical or logical item in QMS — device, computer, instrument — with lifecycle status and CMMS reference | Asset entity | Maximo Asset, ServiceNow CI |
| AsyncIO | Python asynchronous I/O framework for Agent Orchestrator non-blocking execution | Orchestrator runtime | Node.js async, Go goroutines |
| Audit Trail | Immutable, append-only record of all entity changes; DB trigger prevents modification per Part 11 §11.10(e) | AuditTrail entity | Veeva Audit Trail, TrackWise |
| ANVISA | Agência Nacional de Vigilância Sanitária — Brazil's national health surveillance agency regulating pharmaceuticals, medical devices, and biologics; relevant for CODITECT's Brazil market entry (Y3) | Regulatory jurisdiction mapping | FDA, EMA, MHRA, TGA |
| APPI | Act on the Protection of Personal Information — Japan's data protection law governing handling of personal data; relevant for CODITECT's Japan market entry | Regulatory jurisdiction mapping | GDPR, LGPD, PIPEDA |
| ARIA | Accessible Rich Internet Applications — W3C specification for making web content accessible to assistive technologies | WCAG compliance | WAI-ARIA, Section 508 |
| Auth0 | Identity-as-a-Service platform — IdP option for CODITECT SSO integration | IdP integration option | Keycloak, Okta, Azure AD |
| AWS | Amazon Web Services — cloud infrastructure provider; CODITECT architecture is cloud-agnostic but references AWS analogs | Cloud provider reference | GCP, Azure |
B
| Term | Definition | CODITECT Equivalent | Ecosystem Analogs |
|---|---|---|---|
| BAA | Business Associate Agreement — HIPAA-required contract between covered entity and business associate handling PHI | Compliance document | Standard HIPAA BAA |
| BCP | Business Continuity Plan — documented procedures for maintaining operations during disruption | Operational readiness | DRP, DR |
| BDD | Behavior-Driven Development — testing methodology writing tests as user stories in Given/When/Then format | Test strategy option | Cucumber, Jest BDD |
| BOM | Bill of Materials — structured component list referenced in manufacturing work orders | Future WO extension | ERP BOM, MES BOM |
| BPMN | Business Process Model and Notation — standardized graphical notation for business process workflows | Documentation format | UML Activity, Flowcharts |
| BRD | Business Requirements Document — high-level business needs specification | Planning artifact | PRD, MRD |
| Break-Glass | Emergency access mechanism that bypasses normal authorization controls with enhanced logging and mandatory justification; required by HIPAA §164.312(a)(2)(ii) | Emergency access procedure | HIPAA emergency access, privileged access management |
| Buildx | Docker CLI plugin for extended build capabilities including multi-platform image builds and build caching; used in CI/CD pipeline for container image creation | CI/CD build tool | Docker Build, Kaniko |
C
| Term | Definition | CODITECT Equivalent | Ecosystem Analogs |
|---|---|---|---|
| C4 Model | Architecture description framework: Context (C1), Container (C2), Component (C3), Code (C4) | C4 artifact suite | Structurizr, Arc42 |
| CAC | Customer Acquisition Cost — total sales + marketing cost per new customer; target $45K | Revenue metric | SaaS CAC |
| CAGR | Compound Annual Growth Rate — annualized growth rate; QMS market ~8.2% CAGR | Market metric | — |
| CAPA | Corrective and Preventive Action — process triggered by WO rejection patterns indicating systemic quality issues | CODITECT CAPA module | Veeva CAPA, TrackWise CAPA |
| CAPA Action | Individual corrective or preventive task within a CAPA record, tracked to completion with evidence and verification; generates WOs automatically | CAPAAction entity | TrackWise tasks, Veeva actions |
| Canary Deployment | Release strategy routing a small percentage of traffic (10%→50%→100%) to the new version while monitoring error rates and latency before full rollout | Production deployment strategy | Blue-green, rolling update |
| Causation ID | Identifier linking a domain event to the event or command that caused it, enabling causal chain reconstruction in event-driven systems | Event envelope field | Correlation ID (related) |
| CCPA | California Consumer Privacy Act — California data privacy law granting consumers rights over personal data | International compliance | GDPR, LGPD, PIPEDA |
| CDE | Cardholder Data Environment — PCI-DSS defined boundary containing systems that store, process, or transmit cardholder data | PCI-DSS compliance scope | Network segmentation |
| Chaos Engineering | Discipline of proactively injecting failures into production-like systems to discover weaknesses; WO system defines 6 chaos experiments | Testing strategy | Litmus, Chaos Monkey, Gremlin |
| Conway's Law | Observation that system architecture mirrors the communication structure of the organization building it; used in team topology design | Team topology alignment | Inverse Conway Maneuver |
| Cosign | Container image signing tool from Sigstore project; used with Cloud KMS to cryptographically sign container images in CI/CD pipeline | Supply chain security | Notary, Docker Content Trust |
| Cursor Pagination | API pagination method using opaque cursors instead of page numbers; provides consistent results during concurrent modifications | API design pattern | Offset pagination, keyset pagination |
| CDC | Change Data Capture — detecting data changes in PostgreSQL WAL for event publishing | Transactional Outbox pattern | Debezium, Maxwell |
| CDMO | Contract Development and Manufacturing Organization — outsourced pharmaceutical manufacturing | Target customer segment | Lonza, Catalent, Samsung Biologics |
| CFR | Code of Federal Regulations — US federal regulatory law; Title 21 covers FDA regulations | Regulatory framework | — |
| Change Control | Regulated process of planning, executing, reviewing, and approving changes to validated systems | WO Lifecycle Engine | ITIL Change Management |
| ChangeItem | Target of a Work Order — device, system, or document being changed, linked to Asset entity | ChangeItem entity | ServiceNow CI, Maximo Asset |
| Child WO | Execution-level Work Order linked to Master WO via masterId; maps to CODITECT Worker agent pattern | WorkOrder with masterId | Maximo Child WO |
| CI/CD | Continuous Integration / Continuous Deployment — automated build-test-deploy pipeline | Google Cloud Build | Jenkins, GitHub Actions |
| Circuit Breaker | Three-state (closed/open/half-open) failure detection pattern preventing cascading agent failures | Orchestrator component | Hystrix, Resilience4j |
| CLIA | Clinical Laboratory Improvement Amendments — US regulation for laboratory testing quality standards | Adjacent regulatory domain | CAP accreditation |
| CMMS | Computerized Maintenance Management System — manages maintenance, work orders, and assets | Integration target | Maximo, SAP PM, eMaint |
| CODITECT | Autonomous AI development platform for regulated industries by AZ1.AI Inc. | Platform name | — |
| COGS | Cost of Goods Sold — direct delivery costs; primarily compute + AI model tokens | Financial metric | — |
| CPM | Cost Per Mille (thousand) — cost per 1000 tokens in AI model pricing | Token economics metric | — |
| CQRS | Command Query Responsibility Segregation — separate read and write models for state management | Architecture pattern | Event Sourcing complement |
| CRO | Contract Research Organization — outsourced clinical research partner | Target customer segment | IQVIA, Labcorp Drug Dev |
| CRUD | Create, Read, Update, Delete — four basic database operations | Data access pattern | REST verbs mapping |
| CSV | Computer System Validation — FDA-required validation methodology for regulated software systems | Compliance process | IQ/OQ/PQ, GAMP 5 |
| CTE | Common Table Expression — SQL WITH clause for readable complex queries | Database query pattern | — |
| CTO | Chief Technology Officer — technical leadership role; Hal Casteel at AZ1.AI | Executive role | VP Engineering |
| CUID | Collision-resistant Unique Identifier — alternative to UUID for shorter, URL-safe IDs | ID generation option | UUID, ULID, NanoID |
D
| Term | Definition | CODITECT Equivalent | Ecosystem Analogs |
|---|---|---|---|
| DAG | Directed Acyclic Graph — Master/Child WO dependency structure; enforces no circular dependencies | WO hierarchy model | Airflow DAG, Temporal Workflow |
| DDD | Domain-Driven Design — software design approach modeling domain concepts explicitly | Architecture methodology | Bounded Contexts, Aggregates |
| DHF | Design History File — FDA-required documentation of medical device design process | Compliance documentation | 21 CFR 820 |
| DI | Dependency Injection — design pattern for providing object dependencies; InversifyJS in Theia | Theia architecture pattern | Spring DI, Angular DI |
| DICOM | Digital Imaging and Communications in Medicine — healthcare imaging data standard | Integration protocol | HL7, FHIR |
| DMR | Device Master Record — FDA-required documentation containing device specifications and procedures | Compliance documentation | 21 CFR 820 |
| DMS | Document Management System — controlled document storage with versioning and access control | Integration target | SharePoint, Documentum |
| DRP | Disaster Recovery Plan — procedures for restoring systems after catastrophic failure | Operational readiness | BCP, RPO/RTO |
| Data Classification | 5-level taxonomy (L0 Public → L4 Regulated) applied to all data fields, determining encryption, access control, retention, and residency requirements | Data architecture foundation | NIST data classification, ISO 27001 |
| Data Lineage | Tracking of data origin, transformations, and access as a directed acyclic graph; required for regulatory traceability and audit | Lineage tracking engine | Apache Atlas, Marquez, dbt |
| Data Residency | Requirement that data physically resides within a specific geographic jurisdiction; driven by GDPR, LGPD, HIPAA | Tenant-level config (data_residency_region) | Data sovereignty, data localization |
| Data Subject | Individual whose personal data is processed; has rights (access, deletion, portability, correction) under GDPR, LGPD, CCPA | Consent management | Data controller, data processor |
| Deviation | Documented departure from expected result during validation (IQ/OQ/PQ); classified as Critical, Major, Minor, or Observation | Deviation report in validation | Non-conformance, OOS |
| Distroless | Minimal container base images containing only the application runtime and dependencies, with no shell, package manager, or OS tools; reduces attack surface | Container image base | Alpine, scratch, chainguard |
| DLQ | Dead Letter Queue — destination for messages that cannot be processed after maximum retries; monitored for operational issues | NATS DLQ subject | RabbitMQ DLQ, AWS SQS DLQ |
| Domain Event | Immutable record of something that happened in the system, following a standard envelope schema with correlation ID, causation ID, and data classification metadata | Event catalog events | CloudEvents, EventBridge |
| DPIA | Data Protection Impact Assessment — GDPR-required evaluation of processing activities that may result in high risk to data subjects | Privacy compliance | PIA, HIPAA risk assessment |
E
| Term | Definition | CODITECT Equivalent | Ecosystem Analogs |
|---|---|---|---|
| E2E | End-to-End — testing methodology validating complete workflow from input to output | Test strategy | Integration testing |
| EAM | Enterprise Asset Management — lifecycle management of physical assets across an organization | Integration domain | Maximo, SAP EAM |
| EBITDA | Earnings Before Interest, Taxes, Depreciation, and Amortization — profitability metric | Financial metric | — |
| ECN | Engineering Change Notice — formal notification of change to engineering documentation or product | QMS document type | ECO, CAPA |
| ECO | Engineering Change Order — formal authorization to implement an engineering change | QMS document type | ECN, CAPA |
| ECS | Elastic Container Service — AWS managed container orchestration service | Deployment option | GKE, Azure ACI |
| EHR | Electronic Health Record — digital health record system; FDA-regulated integration target | Integration target | Epic, Cerner, MEDITECH |
| ELK | Elasticsearch, Logstash, Kibana — open-source log aggregation and search stack | Observability option | OTEL + Grafana stack |
| ELN | Electronic Laboratory Notebook — digital lab notebook for recording experiments and observations | Adjacent QMS system | LabArchives, Benchling |
| EMA | European Medicines Agency — EU pharmaceutical regulatory authority equivalent to FDA | International regulatory | FDA, MHRA, TGA |
| ePHI | Electronic Protected Health Information — digital health data protected under HIPAA | HIPAA scope | PHI (paper form) |
| ERD | Entity-Relationship Diagram — visual schema representation; WO system has 20+ entities | Design artifact | UML Class Diagram |
| ERP | Enterprise Resource Planning — integrated business management software | Integration target | SAP, Oracle ERP |
| Error Budget | Allowed failure threshold derived from SLO (e.g., 99.95% uptime = 0.05% error budget); when consumed, feature development pauses for reliability work | SLA framework | Google SRE error budgets |
| Event Catalog | Comprehensive inventory of all domain events with schemas, producers, consumers, data classification, and compliance implications | Domain event registry | AsyncAPI, EventCatalog |
| Event Envelope | Standard wrapper for domain events containing metadata (id, type, timestamp, tenant, actor, correlation/causation IDs, data classification) | DomainEvent interface | CloudEvents specification |
| Expand-Contract | Schema evolution pattern: add new column/field (expand), migrate data, switch readers, remove old column (contract); enables zero-downtime migrations | Schema migration strategy | Parallel change, strangler fig |
F
| Term | Definition | CODITECT Equivalent | Ecosystem Analogs |
|---|---|---|---|
| FAT | Factory Acceptance Testing — pre-delivery testing at manufacturer site; maps to IQ validation | Validation phase | IQ, SAT |
| FDA | Food and Drug Administration — US federal agency regulating food, drugs, medical devices, biologics | Primary regulatory body | EMA, MHRA, TGA |
| FHIR | Fast Healthcare Interoperability Resources — HL7 standard for healthcare data exchange | Integration protocol | HL7 v2, DICOM |
| FK | Foreign Key — database constraint linking related tables; enforces referential integrity | Data model constraint | — |
| FMEA | Failure Mode and Effects Analysis — risk assessment methodology identifying potential failure points | Risk management tool | FTA, HAZOP |
| FRS | Functional Requirements Specification — detailed functional behavior of a system | Planning artifact | URS, SRS |
| FSM | Finite State Machine — computational model with discrete states and transitions; WO uses 9-state FSM | WO Lifecycle Engine | XState, Spring SM |
| FSMA | Food Safety Modernization Act — US law for food safety preventive controls | Adjacent regulatory domain | HACCP, GMP |
| FTA | Fault Tree Analysis — top-down risk analysis method using Boolean logic | Risk management tool | FMEA, HAZOP |
| FTE | Full-Time Equivalent — unit measuring one person's full-time workload | Resource metric | — |
| FDA 483 | FDA Form 483 — inspectional observation form listing conditions that may constitute regulatory violations; requires written response within 15 business days | Audit finding type | Warning Letter, Consent Decree |
| Feature Flag | Runtime toggle controlling feature availability per tenant, role, or percentage; in regulated environments, flag state changes are auditable and cannot bypass compliance controls | Feature flag architecture | LaunchDarkly, Flagsmith, Unleash |
| Fishbone Diagram | Root cause analysis tool (also called Ishikawa diagram) categorizing potential causes into People, Process, Technology, Equipment, Materials, Measurement | CAPA root cause method | Five Whys, Fault Tree |
| Fitness Function | Automated architectural test verifying the system still meets its design principles as it evolves (e.g., no L4 data in logs, all endpoints authenticated) | Architecture governance | ArchUnit, fitness functions |
| Five Whys | Root cause analysis technique iteratively asking "why" to drill from symptom to root cause; structured template in CAPA workflow | CAPA root cause method | Fishbone, Fault Tree |
| Fluentbit | Lightweight log processor and forwarder; collects structured JSON logs from containers and ships to Grafana Loki in the observability stack | Log collection agent | Fluentd, Logstash, Vector |
G
| Term | Definition | CODITECT Equivalent | Ecosystem Analogs |
|---|---|---|---|
| GA | General Availability — product release ready for all customers | Release milestone | Beta, RC |
| GAMP | Good Automated Manufacturing Practice — ISPE guidelines for pharmaceutical system validation (GAMP 5) | Validation methodology | IQ/OQ/PQ, CSV |
| GCP | Google Cloud Platform — cloud provider; CODITECT primary deployment target via Google AI Accelerator | Cloud infrastructure | AWS, Azure |
| GDPR | General Data Protection Regulation — EU data privacy regulation affecting data handling and consent | International compliance | HIPAA, PIPEDA, CCPA |
| GKE | Google Kubernetes Engine — managed Kubernetes service on GCP; CODITECT uses GKE Autopilot with multi-zone deployment for production workloads | Container orchestration | EKS (AWS), AKS (Azure) |
| GLBA | Gramm-Leach-Bliley Act — US law requiring financial institutions to protect consumer financial information | Fintech regulatory | SOC 2, PCI-DSS |
| GLP | Good Laboratory Practice — quality standards for non-clinical laboratory studies | Regulatory standard | GMP, GCP (clinical) |
| GM | Gross Margin — revenue minus COGS divided by revenue; target 78% | Financial metric | — |
| GMP | Good Manufacturing Practice — quality standards for manufacturing regulated products | Regulatory standard | GLP, ISO 13485 |
| Golden Image | Verified, compliant system state captured after approved change; used as rollback baseline | WO completion artifact | System snapshot, Checkpoint |
| GRC | Governance, Risk, and Compliance — integrated approach to organizational governance | Integration domain | RSA Archer, ServiceNow GRC |
| GTM | Go-to-Market — strategy for launching products; CODITECT uses 3-phase GTM (Lighthouse→Vertical→Enterprise) | Business strategy | — |
H
| Term | Definition | CODITECT Equivalent | Ecosystem Analogs |
|---|---|---|---|
| HACCP | Hazard Analysis and Critical Control Points — food safety management system based on risk analysis | Adjacent regulatory | FSMA, GMP |
| HAZOP | Hazard and Operability Study — structured risk analysis examining process deviations | Risk management tool | FMEA, FTA |
| HCI | Human-Computer Interface — design discipline for human-system interaction; ACI is the agent equivalent | Design discipline | UX, UI |
| HIPAA | Health Insurance Portability and Accountability Act — US healthcare data privacy and security law | Compliance framework | GDPR, PIPEDA |
| HL7 | Health Level Seven — healthcare interoperability standards organization and protocol family | Integration protocol | FHIR, DICOM |
| HLD | High-Level Design — architectural overview document before detailed design | Design artifact | SDD, C4 Context |
| HPLC | High Performance Liquid Chromatography — analytical technique requiring calibrated instruments tracked in WO system | Instrument type (Tool entity) | GC, Mass Spec |
| HMAC | Hash-based Message Authentication Code — cryptographic method for webhook signature verification using shared secret keys | Webhook security | JWT, API key |
| HPA | Horizontal Pod Autoscaler — Kubernetes resource automatically scaling pod replicas based on CPU, memory, or custom metrics | GKE autoscaling | AWS Auto Scaling |
| Human Checkpoint | Mandatory point where agent execution pauses for human decision; non-negotiable for Part 11 approvals | Checkpoint Manager component | Temporal Human-in-the-Loop |
I
| Term | Definition | CODITECT Equivalent | Ecosystem Analogs |
|---|---|---|---|
| IAM | Identity and Access Management — framework for managing digital identities and access rights | Security infrastructure | AWS IAM, Azure AD, Okta |
| ICH | International Council for Harmonisation — harmonizes pharmaceutical regulatory guidelines globally | Regulatory framework | ICH Q7 (GMP), Q9 (Risk) |
| IaC | Infrastructure as Code — managing and provisioning infrastructure through machine-readable configuration files rather than interactive tools | Terraform modules | Pulumi, CloudFormation, CDK |
| ICU MessageFormat | International Components for Unicode message formatting standard for pluralization, gender, and locale-aware string interpolation | i18n string externalization | FormatJS, react-intl |
| Idempotency | Property where an operation produces the same result regardless of how many times it is applied; enforced via X-Request-ID header preventing duplicate WO operations | API design principle | Idempotency key, exactly-once |
| IDE | Integrated Development Environment — software development workspace; CODITECT uses Eclipse Theia | IDE Shell container | VS Code, JetBrains |
| IdP | Identity Provider — external authentication service providing identity assertions | SSO integration | Auth0, Okta, Azure AD |
| IPO | Initial Public Offering — first sale of stock to public; relevant to market trajectory analysis | Financial milestone | VC, Series funding |
| IQ | Installation Qualification — validation proving system installed correctly per specifications | Validation phase (IQ/OQ/PQ) | GAMP 5 |
| IQ/OQ/PQ | Installation/Operational/Performance Qualification — three-phase validation methodology for regulated systems | Validation protocol suite | GAMP 5, CSV |
| IQVIA | Global CRO and health information technology company — market data source | Market reference | Veeva, ICON |
| IR | Investor Relations — communication between company and investment community | Business function | — |
| IRR | Internal Rate of Return — discount rate making NPV of investment zero | Financial metric | NPV, ROI |
| ISO | International Organization for Standardization — publishes quality and safety standards (13485, 27001, 9001) | Compliance standards | AICPA, FDA |
| ISPE | International Society for Pharmaceutical Engineering — publishes GAMP guidelines | Industry body | PDA, AICPA |
| ITIL | Information Technology Infrastructure Library — IT service management best practices framework | Process framework | COBIT, ISO 20000 |
| ITSM | IT Service Management — managing IT services lifecycle; ITIL-based | Process domain | ServiceNow ITSM, BMC |
| IVD | In Vitro Diagnostic — medical device for testing specimens outside the body | Device classification | IVDR (EU regulation) |
| IVDR | In Vitro Diagnostic Regulation — EU regulation for IVD medical devices (2017/746) | EU regulatory | FDA 21 CFR 809 |
J
| Term | Definition | CODITECT Equivalent | Ecosystem Analogs |
|---|---|---|---|
| JobPlan | Execution blueprint for a Work Order — defines steps, skills, tools, materials, and work instructions | JobPlan entity | Maximo Job Plan |
| JSONB | JSON Binary — PostgreSQL binary JSON data type enabling indexed queries on semi-structured data | Database column type | MongoDB BSON |
| JSX | JavaScript XML — React syntax extension for describing UI components; used for all dashboard artifacts | Dashboard file format | TSX (TypeScript variant) |
| JWT | JSON Web Token — compact, signed token for API authentication and authorization | API Gateway auth | OAuth 2.0 access tokens |
K
| Term | Definition | CODITECT Equivalent | Ecosystem Analogs |
|---|---|---|---|
| KPI | Key Performance Indicator — measurable value demonstrating operational effectiveness | Business metric | OKR (complementary) |
| Kustomize | Kubernetes-native configuration management tool using overlays to customize base manifests per environment without templating | K8s manifest management | Helm, jsonnet |
L
| Term | Definition | CODITECT Equivalent | Ecosystem Analogs |
|---|---|---|---|
| LangGraph | LangChain framework for building stateful multi-agent workflows with graph-based orchestration | Agent orchestration analog | Temporal, Prefect |
| LGPD | Lei Geral de Proteção de Dados — Brazil's general data protection law, analogous to GDPR; relevant for CODITECT's Brazil market entry (Y3) | Regulatory jurisdiction mapping | GDPR, CCPA, APPI |
| LIMS | Laboratory Information Management System — manages lab samples, tests, and workflows | Adjacent QMS system | LabVantage, STARLIMS |
| LLM | Large Language Model — AI model architecture powering CODITECT agents (Claude Opus/Sonnet/Haiku) | Agent intelligence layer | GPT, Gemini, Llama |
| LTV | Lifetime Value — projected total revenue from a customer; target $840K (3.5 years × $240K ACV) | Revenue metric | SaaS LTV |
M
| Term | Definition | CODITECT Equivalent | Ecosystem Analogs |
|---|---|---|---|
| MADR | Markdown ADR format — standardized template for Architecture Decision Records | ADR template format | Nygard ADR |
| Master WO | Parent Work Order coordinating multiple child WOs; uses DAG hierarchy with aggregation rules | WorkOrder with children | Maximo Master WO |
| MDR | Medical Device Regulation — EU regulation for medical devices (2017/745) replacing MDD | EU regulatory | FDA 21 CFR 820 |
| MES | Manufacturing Execution System — controls and monitors manufacturing processes in real-time | Integration target | Siemens Opcenter, Rockwell |
| MFA | Multi-Factor Authentication — authentication requiring 2+ verification factors; required for e-signatures | Signature security | TOTP, FIDO2, SMS |
| MHRA | Medicines and Healthcare products Regulatory Agency — UK pharmaceutical regulatory authority | International regulatory | FDA, EMA, TGA |
| Model Router | CODITECT component selecting optimal AI model per task segment based on complexity and regulatory flags | Orchestrator component | CODITECT differentiator |
| MRR | Monthly Recurring Revenue — ARR divided by 12; Y3 target $2.4M/month | Revenue metric | SaaS MRR |
| MQL | Marketing Qualified Lead — prospect who has engaged with marketing content and meets firmographic criteria; feeds sales pipeline in GTM strategy | GTM funnel stage | PQL, SQL (Sales) |
| mTLS | Mutual TLS — bidirectional certificate authentication between services | Inter-service security | Service mesh, Istio |
| MVP | Minimum Viable Product — smallest feature set validating core value proposition | Product milestone | POC, Pilot |
N
| Term | Definition | CODITECT Equivalent | Ecosystem Analogs |
|---|---|---|---|
| NATS | Neural Autonomic Transport System — high-performance messaging system for event bus | Event Bus option | Redis Streams, RabbitMQ |
| NDA | Non-Disclosure Agreement — legal contract protecting confidential information; required for auditor access, customer demonstrations, and enterprise sales | Legal/compliance document | Mutual NDA, CNDA |
| NCR | Non-Conformance Report — document recording deviation from specifications or procedures | QMS document type | CAPA, SCAR |
| NPV | Net Present Value — present value of future cash flows minus initial investment | Financial metric | IRR, ROI |
| NRR | Net Revenue Retention — revenue from existing customers including expansion minus churn; target 140% | Revenue metric | SaaS NRR, NDR |
O
| Term | Definition | CODITECT Equivalent | Ecosystem Analogs |
|---|---|---|---|
| OIDC | OpenID Connect — identity layer on OAuth 2.0 for SSO authentication | SSO protocol | SAML, OAuth 2.0 |
| OKR | Objectives and Key Results — goal-setting framework for measuring outcomes | Business planning | KPI (complementary) |
| OOTB | Out of the Box — functionality available without customization | Feature classification | Custom, Configurable |
| OQ | Operational Qualification — validation proving system operates correctly under expected conditions | Validation phase (IQ/OQ/PQ) | GAMP 5 |
| ORM | Object-Relational Mapping — abstraction layer mapping objects to database tables; Prisma in CODITECT | Data access layer | TypeORM, Sequelize, SQLAlchemy |
| OTEL | OpenTelemetry — observability framework for traces, metrics, and logs across distributed systems | Observability stack | Jaeger, Zipkin, Datadog |
| OTP | One-Time Password — single-use authentication code for MFA; used in e-signature re-authentication | Authentication mechanism | TOTP, HOTP |
| OWASP | Open Worldwide Application Security Project — nonprofit producing security tools, standards, and the OWASP Top 10 vulnerability list; referenced in security architecture threat modeling | Security standards | CWE, NIST CSF |
P
| Term | Definition | CODITECT Equivalent | Ecosystem Analogs |
|---|---|---|---|
| PCI-DSS | Payment Card Industry Data Security Standard — security standard for handling credit card data | Fintech compliance | SOC 2, GLBA |
| PDA | Parenteral Drug Association — global pharmaceutical and biopharmaceutical science organization | Industry body | ISPE, ICH |
| PHI | Protected Health Information — individually identifiable health data regulated under HIPAA | Data classification | ePHI (electronic form), PII |
| PIC/S | Pharmaceutical Inspection Co-operation Scheme — international GMP harmonization body | Regulatory body | ICH, ISPE |
| PII | Personally Identifiable Information — data that can identify an individual | Data classification | PHI (health-specific) |
| PIPEDA | Personal Information Protection and Electronic Documents Act — Canadian privacy law | International compliance | GDPR, CCPA |
| PKI | Public Key Infrastructure — framework for managing digital certificates and encryption keys | Security infrastructure | Certificate Authority, mTLS |
| PLM | Product Lifecycle Management — managing entire lifecycle of a product from inception to disposal | Integration domain | Siemens Teamcenter, PTC |
| PM | Product Manager or Project Manager — role responsible for product/project direction | Business role | PMM, PO |
| PMA | Pre-Market Approval — FDA's most rigorous device marketing pathway for Class III devices | Regulatory pathway | 510(k), De Novo |
| PMF | Product-Market Fit — degree to which a product satisfies strong market demand | Business milestone | MVP validation |
| PMM | Product Marketing Manager — role bridging product development and go-to-market | Business role | PM, GTM lead |
| POC | Proof of Concept — minimal implementation validating technical feasibility | Development milestone | MVP, Pilot |
| PQ | Performance Qualification — validation proving system performs consistently under real-world conditions | Validation phase (IQ/OQ/PQ) | GAMP 5 |
| PRD | Product Requirements Document — detailed product feature and behavior specification | Planning artifact | BRD, FRS |
| PagerDuty | Incident management platform for on-call alerting, escalation, and incident response automation | Alert routing destination | Opsgenie, VictorOps |
| PIR | Post-Incident Review — structured analysis of an incident after resolution covering timeline, root cause, impact, and corrective actions; P0 requires PIR within 5 business days | Incident response artifact | Postmortem, RCA, blameless retro |
| Poka-yoke | Error-proofing design principle from manufacturing; in CODITECT, applied to tool design so AI agents cannot make common mistakes (Anthropic ACI Principle 3) | Tool Engineering principle | Defensive design, guardrails |
| Pact | Consumer-driven contract testing framework verifying API compatibility between service providers and consumers; used in CI pipeline for agent and API contract tests | Contract testing tool | Spring Cloud Contract, Specmatic |
| PITR | Point-in-Time Recovery — PostgreSQL capability to restore a database to any specific moment using base backups + WAL replay; Tier 3 RPO strategy for agent logs | Database recovery mechanism | WAL replay, flashback |
| PLG | Product-Led Growth — GTM strategy where the product itself drives acquisition, activation, and expansion; contrasted with sales-led and marketing-led motions | GTM strategy option | Sales-led, marketing-led |
| PQL | Product Qualified Lead — user who has demonstrated meaningful product engagement (e.g., completed onboarding, created 5+ WOs) qualifying them for sales outreach | GTM funnel stage | MQL, SQL (Sales) |
| Prisma | TypeScript ORM and schema definition tool; used for CODITECT data model definition | Data access layer | TypeORM, Drizzle |
Q
| Term | Definition | CODITECT Equivalent | Ecosystem Analogs |
|---|---|---|---|
| QA | Quality Assurance — role ensuring quality standards; in WO system, QA approves regulatory changes with e-signature | RBAC role | Quality Manager |
| QMS | Quality Management System — organizational system for quality policies, objectives, and processes | Domain context | ISO 9001, ISO 13485 |
| QSR | Quality System Regulation — FDA 21 CFR 820 requirements for medical device quality systems | Regulatory standard | ISO 13485, EU MDR |
R
| Term | Definition | CODITECT Equivalent | Ecosystem Analogs |
|---|---|---|---|
| RBAC | Role-Based Access Control — access model with 8 roles: Originator, Assigner, Assignee, System Owner, QA, Vendor, Admin, Auditor | Access control model | ABAC, ACL |
| REST | Representational State Transfer — architectural style for web APIs; CODITECT API Gateway uses REST | API style | gRPC, GraphQL |
| RFC 7807 | Problem Details for HTTP APIs — standard format for machine-readable error responses; used for all WO API error responses | API error format | GraphQL errors, gRPC status |
| Risk Matrix | 5×5 grid (likelihood × impact) producing risk scores 1–25; determines CAPA priority, approval escalation, and timeline requirements | Risk assessment tool | FMEA severity × occurrence |
| Risk Score | Numerical product of likelihood (1–5) × impact (1–5); scores ≤6 Low, 7–12 Medium, 13–19 High, 20–25 Critical | CAPA prioritization | Risk Priority Number (RPN) |
| RLS | Row-Level Security — PostgreSQL feature filtering rows by tenant_id; enforces multi-tenant isolation | Data isolation mechanism | Oracle VPD, SQL Server RLS |
| ROI | Return on Investment — gain from investment relative to cost; compliance automation delivers 300-500% ROI | Financial metric | NPV, IRR |
| Root Cause | Fundamental reason why a non-conformance occurred; determined via Five Whys, Fishbone, or Fault Tree analysis during CAPA workflow | CAPA root cause analysis | RCA (Root Cause Analysis) |
| RPC | Remote Procedure Call — protocol for executing functions on remote systems | Communication pattern | gRPC, JSON-RPC |
| RPO | Recovery Point Objective — maximum acceptable data loss measured in time | Disaster recovery metric | RTO |
| RTO | Recovery Time Objective — maximum acceptable downtime after failure | Disaster recovery metric | RPO |
| Raft | Distributed consensus algorithm used by NATS JetStream and HashiCorp Vault for leader election and data replication across cluster nodes | Cluster consensus | Paxos, ZAB (ZooKeeper) |
S
| Term | Definition | CODITECT Equivalent | Ecosystem Analogs |
|---|---|---|---|
| SAGA | Distributed transaction pattern using compensating transactions for multi-step workflows | Event-driven coordination | Temporal Workflow, Cadence |
| SAM | Serviceable Addressable Market — portion of TAM reachable with current product; $1.9B across 6 segments | Market metric | TAM, SOM |
| SAML | Security Assertion Markup Language — XML-based SSO protocol for enterprise authentication | SSO protocol | OIDC, OAuth 2.0 |
| SAT | Site Acceptance Testing — post-delivery testing at customer site; maps to OQ validation | Validation phase | FAT, OQ |
| SBOM | Software Bill of Materials — inventory of all software components, dependencies, and versions in a delivered artifact; generated by Syft in SPDX format per supply chain security | Supply chain security | CycloneDX, SWID |
| SCAR | Supplier Corrective Action Request — formal request to supplier to address quality issue | QMS document type | NCR, CAPA |
| SDD | System Design Document — high-level system architecture with context diagrams, components, scaling model | Architecture artifact | HLD, C4 model |
| SDK | Software Development Kit — tools and libraries for building applications on a platform | Developer tooling | API, CLI |
| SDLC | Software Development Lifecycle — phases of software creation from planning to maintenance | Development process | Agile, Waterfall |
| Seed Data | Synthetic, reproducible dataset used to populate non-production environments; in regulated systems, must never contain real PHI/PII and must cover all state machine paths | Test data management | Fixtures, factories, faker |
| SHA-256 | Secure Hash Algorithm (256-bit) — cryptographic hash function for audit trail checksums and integrity verification | Data integrity mechanism | MD5 (deprecated), SHA-3 |
| SIEM | Security Information and Event Management — security monitoring with log correlation and alerting | Security integration | Splunk, QRadar, Sentinel |
| SLA | Service Level Agreement — contractual performance commitments (uptime, response time) | Operational metric | SLI, SLO |
| SLI | Service Level Indicator — measured metric feeding SLO calculations (latency, error rate, throughput) | Observability metric | SLA, SLO |
| SLO | Service Level Objective — target value for an SLI; internal goal informing SLA | Operational target | SLI, SLA |
| Smoke Test | Minimal post-deployment verification that critical paths function; run after every production deployment before full traffic shift | Post-deploy validation | Canary test, health check |
| Semgrep | Lightweight static analysis tool using pattern-matching rules for security scanning, code quality, and policy enforcement in CI pipelines | Security scanning (CI) | ESLint, SonarQube, CodeQL |
| Service Mesh | Infrastructure layer handling service-to-service communication with features like mTLS, load balancing, and observability; referenced in zero-trust network architecture | Network security option | Istio, Linkerd, Envoy |
| Snyk | Developer-first security platform for vulnerability scanning of dependencies, containers, and IaC; used alongside Trivy in CI pipeline | Dependency scanning (CI) | Dependabot, Grype, Renovate |
| SOC 2 | Service Organization Control Type 2 — AICPA trust service criteria audit for security, availability, integrity | Compliance framework | ISO 27001, SOC 1 |
| SOD | Separation of Duties — control principle preventing one person from completing conflicting tasks; 6 rules enforced | Security constraint | Dual control, four-eyes |
| SOM | Serviceable Obtainable Market — realistic market capture; Y3 target $28.8M ARR (120 customers) | Market metric | TAM, SAM |
| SOP | Standard Operating Procedure — documented step-by-step instructions for routine operations | QMS document type | WI, Work Instruction |
| SPDX | Software Package Data Exchange — Linux Foundation standard format for communicating SBOM component information | SBOM output format | CycloneDX, SWID |
| SQL | Structured Query Language — standard language for relational database operations | Database interface | — |
| SRS | Software Requirements Specification — detailed technical requirements document | Planning artifact | FRS, URS |
| SSL | Secure Sockets Layer — predecessor to TLS; deprecated but term still commonly used | Legacy security protocol | TLS 1.3 (current) |
| SSO | Single Sign-On — one login grants access to multiple systems; OIDC/SAML-based | API Gateway integration | Okta, Azure AD |
| State Machine | 9-state lifecycle engine with composable guards (DRAFT→PLANNED→SCHEDULED→IN_PROGRESS→PENDING_REVIEW→APPROVED/REJECTED→COMPLETED/CANCELLED) | WO Lifecycle Engine | XState, Spring SM |
| STRIDE | Spoofing, Tampering, Repudiation, Information Disclosure, Denial of Service, Elevation of Privilege — Microsoft's threat modeling methodology used in security architecture | Threat model framework | PASTA, DREAD, LINDDUN |
| Syft | Open-source SBOM generation tool from Anchore; produces SPDX or CycloneDX output from container images and source code | CI/CD SBOM generation | Trivy (also generates SBOM) |
T
| Term | Definition | CODITECT Equivalent | Ecosystem Analogs |
|---|---|---|---|
| TAM | Total Addressable Market — total demand; primary $3.5B (Change Control $2.1B + CSV $1.4B by 2028) | Market metric | SAM, SOM |
| TCO | Total Cost of Ownership — complete cost including purchase, deploy, operate, maintain | Business metric | ROI |
| TDD | Technical Design Document — implementation spec with APIs, data models, deployment. Also: Test-Driven Development | Architecture artifact / Test methodology | — |
| TDE | Transparent Data Encryption — database-level encryption for data at rest (AES-256) | PostgreSQL encryption | Oracle TDE |
| Temporal | Durable execution platform for long-running workflows with built-in retry and state persistence | Agent orchestration analog | LangGraph, Prefect |
| Tenant | Isolated customer organization; all data partitioned by tenant_id with PostgreSQL RLS | Platform tenant model | SaaS multi-tenancy |
| Terraform | HashiCorp Infrastructure as Code tool for defining and provisioning cloud resources declaratively; CODITECT uses modular structure with environment overlays | IaC framework | Pulumi, CloudFormation, CDK |
| TGA | Therapeutic Goods Administration — Australian pharmaceutical and medical device regulatory authority | International regulatory | FDA, EMA, MHRA |
| Theia | Eclipse Theia — open-source IDE framework with InversifyJS DI; CODITECT developer interface | IDE Shell container | VS Code, JetBrains |
| Time Entry | Actual work record — person, vendor, hours, rate type, cost center for WO execution tracking | TimeEntry entity | Maximo Labor |
| TLS | Transport Layer Security (v1.3) — cryptographic protocol securing network communications | Network security | mTLS, SSL (deprecated) |
| Token Budget | Pre-allocated token limit per agent; warning at 80%, hard stop at 95% to control AI costs | Budget Controller | CODITECT differentiator |
| Tool | Physical equipment for WO execution — tracked with calibration status and availability windows | Tool entity | Maximo Tool |
| Transactional Outbox | Events written to outbox table in same database transaction as state change, then published to event bus | Event Bus integration pattern | Debezium CDC |
| Trivy | Open-source container vulnerability scanner by Aqua Security; blocks CI builds with Critical/High CVEs; also generates SBOMs | Container security scanning | Snyk, Grype, Clair |
| TSC | Trust Service Criteria — AICPA framework defining SOC 2 audit categories (Security, Availability, Processing Integrity, Confidentiality, Privacy) | SOC 2 compliance framework | ISO 27001 controls |
| TSX | TypeScript JSX — TypeScript variant of JSX for type-safe React components | Code file format | JSX (JavaScript) |
| TTL | Time To Live — expiration duration for cached data, tokens, session, or signature delegation | Configuration parameter | Cache TTL |
| Two-Phase Signature | Phase 1: create ElectronicSignature record, Phase 2: bind to Approval — consumed flag prevents reuse | Signature Service pattern | CODITECT innovation |
U
| Term | Definition | CODITECT Equivalent | Ecosystem Analogs |
|---|---|---|---|
| UAT | User Acceptance Testing — end users validate system meets requirements before production deployment | Validation phase | PQ |
| ULID | Universally Unique Lexicographically Sortable Identifier — time-ordered alternative to UUID | ID generation option | UUID, CUID |
| UML | Unified Modeling Language — standardized visual modeling notation for software systems | Documentation format | C4, BPMN |
| URS | User Requirements Specification — document capturing user needs and expectations | Planning artifact | FRS, SRS |
| UUID | Universally Unique Identifier — 128-bit globally unique ID used as primary key for all entities | Primary key format | ULID, CUID |
| UUID v7 | Time-ordered UUID variant (RFC 9562) — embeds Unix timestamp for natural chronological ordering; used for event IDs and idempotency keys | Event and request ID format | ULID, CUID, UUID v4 |
| UX | User Experience — design discipline focused on user interaction quality and satisfaction | Design practice | UI, HCI |
V
| Term | Definition | CODITECT Equivalent | Ecosystem Analogs |
|---|---|---|---|
| Validation Status | Asset classification: VALIDATED, PENDING_VALIDATION, NOT_APPLICABLE — determines regulatory controls applied | Asset.validationStatus | GxP validation state |
| VC | Venture Capital — private equity investment in early-stage companies; relevant to funding strategy | Funding source | Angel, Series A/B/C |
W
| Term | Definition | CODITECT Equivalent | Ecosystem Analogs |
|---|---|---|---|
| WAL | Write-Ahead Log — PostgreSQL mechanism writing changes to log before data pages; basis for CDC and replication | Database mechanism | Redo log, Binlog |
| WASM | WebAssembly — binary instruction format for browser-native code execution at near-native speed | IDE terminal option | — |
| WCAG | Web Content Accessibility Guidelines — W3C standard for web accessibility; WO system targets WCAG 2.1 AA compliance for all user-facing interfaces | Accessibility standard | Section 508, ARIA, ADA |
| Webhook | HTTP callback delivering real-time event notifications to external systems; WO system supports 8+ subscribable event types with HMAC signature verification | Integration pattern | Polling, WebSocket, SSE |
| WI | Work Instruction — controlled step-by-step execution document referenced by JobPlan | JobPlan.workInstructionRef | SOP, Maximo WI |
| WO | Work Order — atomic change control record; fundamental unit of regulated change management in QMS | WorkOrder entity | Maximo WO, ServiceNow Change |
| WOMS | Work Order Management System — complete system managing WO lifecycle from creation to completion | WO Engine | Maximo, ServiceNow |
| Workload Identity | GKE mechanism binding Kubernetes service accounts to GCP IAM service accounts; eliminates need for exported key files in containers | GKE IAM integration | AWS IRSA, Azure Workload Identity |
| WTP | Willingness To Pay — maximum price a customer will pay for a solution; used in pricing analysis | Pricing metric | Price sensitivity |
X
| Term | Definition | CODITECT Equivalent | Ecosystem Analogs |
|---|---|---|---|
| XState | JavaScript/TypeScript state machine and statechart library — analog for WO state machine | State machine analog | Spring SM, Akka FSM |
Y–Z
| Term | Definition | CODITECT Equivalent | Ecosystem Analogs |
|---|---|---|---|
| Zero Trust | Security model assuming no implicit trust for any entity inside or outside the network; every request is authenticated, authorized, and encrypted regardless of origin | Network security architecture | BeyondCorp, ZTNA, SASE |
No additional terms currently defined for Y.
Total terms: 400+
Coverage: All 79+ artifacts (markdown + JSX + ADRs + meta-prompts), system prompt v8.0, specification documents, and gap closure series
Last updated: 2026-02-13
Copyright 2026 AZ1.AI Inc. All rights reserved. Developer: Hal Casteel, CEO/CTO Product: CODITECT-BIO-QMS | Part of the CODITECT Product Suite Classification: Internal - Confidential