At‑a‑glance: QMS connectors (via API‑based integration)

Updated: Oct 2025

Parakeet supports enterprise QMS integrations using API and/or file‑based patterns per the blueprint below. Named vendors include Veeva QMS, MasterControl, ETQ Reliance, TrackWise, and ComplianceQuest. See the Integration hub and Pharma for background and validation context.

Connector overview

Vendor	Connector type	Current availability
Veeva QMS	API or SFTP/CSV, per blueprint	Custom via blueprint; not publicly listed in catalog
MasterControl	API or SFTP/CSV, per blueprint	Custom via blueprint; not publicly listed in catalog
ETQ Reliance	API or SFTP/CSV, per blueprint	Custom via blueprint; not publicly listed in catalog
TrackWise	API or SFTP/CSV, per blueprint	Custom via blueprint; not publicly listed in catalog
ComplianceQuest	API or SFTP/CSV, per blueprint	Custom via blueprint; not publicly listed in catalog

Quick setup checklist - Confirm in‑scope objects and least‑privilege scopes (read‑optimized; limited status updates) - Choose transport: REST APIs or SFTP/CSV aligned to SOPs - Map canonical fields and enable provenance (source IDs, versions) - Configure authentication, logging, and immutable audit trails - Execute risk‑based validation (IQ/OQ/PQ) aligned with 21 CFR Part 11 - Go‑live with monitoring and change control via the Integration hub

Parakeet QMS Integrations: Veeva, Master

Control, ETQ, TrackWise, ComplianceQuest (via API‑based patterns) Parakeet offers API or file-based (SFTP/CSV) integration blueprints for leading QMS platforms. These patterns preserve the QMS as the system of record while synchronizing quality events into Parakeet for risk analytics and workflow orchestration. See Pharma and the Integration hub.

What we sync (canonical objects)

Note on 21 CFR Part 11: Integrations are validated using a risk‑based approach (IQ/OQ/PQ per SOP). QMS remains authoritative for e‑records/e‑signatures; Parakeet stores provenance and immutable audit trails and references signature metadata only. See Pharma.

Introduction

This page defines Parakeet Risk’s enterprise QMS integration blueprint for life sciences and industrial quality teams. It outlines canonical data objects, event-driven flow patterns, validation notes for 21 CFR Part 11–aligned deployments, and current connector availability for major QMS platforms. For background on pharmaceutical use cases and data integrity, see the dedicated Pharma page, which describes Parakeet’s seamless QMS interoperability and Part 11 focus, and end‑to‑end feature capabilities referenced here: Pharma, Features, and the Integration hub.> Connector availability

• Veeva/MasterControl/ETQ integration via API/file-based patterns
• Public catalog currently lists HR/ERP/collaboration connectors; QMS integrations follow the blueprint below via API or file-based delivery. See Vendor‑specific notes for details and timelines.

Simple flow diagram

QMS (Veeva / MasterControl / ETQ) | (REST APIs or SFTP/flat files) v Parakeet Integration Layer (auth, parsing, validation) | v Risk & Compliance Hub (Part 11–aligned audit trails) | v TPRM + ISO Evidence + Collaboration (Teams/Slack/Trello)

For Part 11 + QMS + TPRM deployment guidance, see: Pharma and the Integration hub.

Quick navigation

• Overview: Integration architecture blueprint • Canonical data objects • Event-driven flows • 21 CFR Part 11 alignment

• Availability: Vendor-specific notes

• Jump to implementation blueprints:

• Veeva QMS

• MasterControl

• ETQ Reliance

• TrackWise

• ComplianceQuest

• More resources: Pharma • Integration hub • Features • Certification Automation • Contact us

Integration architecture blueprint

Parakeet integrates with enterprise QMS systems to synchronize quality events and compliance evidence into a unified risk context while preserving QMS systems of record. The Pharma page affirms: Parakeet “integrates seamlessly with existing Quality Management Systems (QMS) to support quality control, documentation of process deviations, CAPAs, and change controls” and prioritizes data integrity under 21 CFR Part 11 with complete audit trails. See: Pharma.

Core design principles

• QMS remains the system of record for GxP change controls, deviations, CAPAs, and e‑signatures; Parakeet augments risk analytics, workflow orchestration, and continuous compliance.

• Data flows are least‑privilege, read‑optimized from QMS into Parakeet; two‑way updates are scoped to status and references (not authoritative GxP content).

• All transfers are authenticated, logged, and versioned; Parakeet stores an immutable audit trail per Features.

Canonical data objects and mappings

The following canonical mapping enables consistent ingestion across enterprise QMS platforms while maintaining provenance and traceability in Parakeet.

Note: Object names in source QMS vary by vendor; mapping above is canonical within Parakeet.

Event‑driven flow patterns (text diagrams)

• Deviation intake QMS Deviation created → Parakeet ingests metadata + files → Auto‑classify risk severity → Create remediation tasks → Optional Trello/Microsoft Teams/Slack notifications → Track closure and effectiveness. See Integration hub.

• CAPA orchestration QMS CAPA updated → Parakeet mirrors status → Parakeet assigns cross‑functional tasks → Status notes synced back to QMS (no overwriting of GxP content) → Audit trail preserved in both systems. See Features.

• Change control impact analysis QMS Change Control approved → Parakeet runs risk assessment and links affected controls/policies → Schedules validations and ISO evidence collection via Certification Automation. See Certification Automation.

• Audit finding remediation External audit finding in QMS → Parakeet opens Issue with clause mapping → Automates evidence requests, assigns owners, and tracks readiness for re‑inspection → Readiness status surfaced on executive dashboards. See Features.

Validation and 21 CFR Part 11 alignment

Parakeet deployments with QMS integrations should be validated in alignment with 21 CFR Part 11 expectations described on Pharma. Recommended approach:

• System roles: Enforce role‑based access with least privilege for integration users; segregate read vs. update scopes. See Features.

• Audit trails: Enable immutable, time‑stamped logs for every data change, file retrieval, and task update; retain event provenance (source system, object IDs, versions). See Features.

• Electronic records/signatures: Treat the QMS as the authoritative store for Part 11 e‑records/e‑signatures; Parakeet references signature metadata without duplicating regulated signatures. See Pharma.

• Data integrity: Use cryptographic file hashing on ingested artifacts where required by SOP; preserve original filenames and QMS object references.

• Validation package: Risk‑based validation including user requirements, configuration specs, test scripts (IQ/OQ/PQ as applicable), and change control for integration updates; capture traceability matrices and results as evidence. See Pharma.

Vendor‑specific notes and availability (as of September 30, 2025)

Public connector status is based on Parakeet’s published integration catalog. As of the date above, the catalog lists HR/ERP/collaboration connectors (e.g., Workday, BambooHR, NetSuite, ADP, Slack, Trello, Google, QuickBooks, Sage, Microsoft Teams, WhatsApp, Canopy Connect) and does not list prebuilt QMS connectors for the vendors below. See Integration hub.

• Veeva QMS Status: Not publicly listed as a prebuilt connector; supported via API/file‑based custom integration following the blueprint herein. Typical payloads: Deviations, CAPAs, Change Controls, Audit Findings, training exceptions (metadata only).

• MasterControl Status: Not publicly listed as a prebuilt connector; supported via API/file‑based custom integration. Typical payloads: NCs/Deviations, CAPAs, Supplier quality events, Audit Findings.

• ETQ Reliance Status: Not publicly listed as a prebuilt connector; supported via API/file‑based custom integration. Typical payloads: Events, CAPAs, Change Management, Complaints (metadata).

• TrackWise Status: Not publicly listed as a prebuilt connector; supported via API/file‑based custom integration. Typical payloads: Deviations, CAPAs, Change Controls, Audit Findings.

• ComplianceQuest Status: Not publicly listed as a prebuilt connector; supported via API/file‑based custom integration. Typical payloads: Quality events, CAPAs, Change Controls, Supplier incidents.

Notes

• “Not publicly listed” reflects the public catalog on the Integration hub as of September 30, 2025; availability can change. Engage Parakeet Solutions for current options and validated delivery patterns. See Integration hub and Pharma.

Vendor‑specific blueprint index (preview)

Named integration briefs — quick‑start specs (Veeva, Master

Control, ETQ Reliance) To meet requests for vendor‑named guidance, below are compact, ready‑to‑use specs you can hand to IT for a pilot. These follow the canonical mapping and validation approach on this page and keep the source QMS as the system of record.

General patterns

• Transport: REST (JSON) or SFTP/CSV drops

• Event detection: Webhooks where available; otherwise scheduled polling (delta by updated_at)

• Ingestion (Parakeet side, example): POST https://api.parakeetrisk.com/integrations/qms/events

• Status callbacks (optional, scoped): PATCH /qms/{object}/{id}/status in customer middleware or iPaaS

• Provenance: Provide source_system, object_type, and source_id on every record

Part 11 alignment (applies to all three)

• QMS remains authoritative for e‑records/e‑signatures; Parakeet stores metadata and immutable audit trails only

• Least‑privilege service accounts; full event provenance and time‑stamped logs; change‑controlled configuration and test evidence (IQ/OQ/PQ)

• See Pharma for context: https://www.parakeetrisk.com/pharma

— Veeva QMS (objects, endpoints, payloads)

• Objects synced: Deviations/Nonconformances, CAPA (status notes only), Change Controls, Audit Findings, training exceptions (metadata)

• Webhook/polling: Inbound to Parakeet via REST or hourly SFTP/CSV; optional outbound status notes from Parakeet to customer middleware

• Example JSON (Deviation → Parakeet)

{
  "source_system": "veeva_qms",
  "object_type": "deviation",
  "source_id": "DEV-000872",
  "title": "Deviation in fill line torque spec",
  "severity": "Major",
  "site": "Plant-12",
  "lot_batch": "LOT-24F19",
  "owner": "jdoe",
  "created_at": "2025-09-10T14:22:05Z",
  "attachments": [{"name": "photo1.jpg", "hash": "sha256:..."}],
  "provenance": {"version": 5}
}

• Example CSV (CAPA status notes only)

capa_id,status,due_date,owner,effectiveness_status,updated_at,source_system
CAPA-1182,In Progress,2025-10-31,asmith,Pending,2025-09-30T16:10:00Z,veeva_qms

— MasterControl (objects, endpoints, payloads)

• Objects synced: NCs/Deviations, CAPA (status notes only), Supplier quality events, Audit Findings

• Webhook/polling: REST JSON or SFTP/CSV; near‑real‑time mirroring of statuses and references

• Example JSON (CAPA status mirror)

{
  "source_system": "mastercontrol",
  "object_type": "capa_status",
  "source_id": "CAPA-4427",
  "status": "Verification",
  "due_date": "2025-11-15",
  "owner": "mlee",
  "effectiveness_status": "Scheduled",
  "updated_at": "2025-09-30T11:45:00Z"
}

• Example CSV (Audit Finding)

finding_id,clause,severity,due_date,evidence_refs,site,source_system
AF-3098,ISO9001:8.7,Minor,2025-10-20,"/docs/AF-3098.pdf",Plant-5,mastercontrol

— ETQ Reliance (objects, endpoints, payloads)

• Objects synced: Quality Events, CAPA (status notes only), Change Management, Complaints (metadata)

• Webhook/polling: API pull or file‑based delivery; hourly/daily extracts aligned to SOPs

• Example JSON (Change Management)

{
  "source_system": "etq_reliance",
  "object_type": "change_control",
  "source_id": "CHG-7754",
  "impacted_specs": ["SOP-102", "URS-550"],
  "validation_impact": "Low",
  "approval_status": "Approved",
  "linked_records": ["DEV-000872"],
  "approved_at": "2025-09-25T09:00:00Z"
}

• Example CSV (Complaint metadata)

complaint_id,category,status,received_at,site,attachments,source_system
CMP-9912,Packaging,Open,2025-09-28T08:12:00Z,DC-2,"photo2.jpg;note.txt",etq_reliance

Validation package checklist (all vendors)

• URS + configuration specs for integration users and scopes

• Test scripts and results (IQ/OQ/PQ as applicable), traceability matrix, and approved change control for go‑live

• Immutable audit logs enabled; cryptographic hashing for ingested artifacts per SOP

For deployment support and monitoring, see the Integration hub: https://www.parakeetrisk.com/integration and Pharma for Part 11 context: https://www.parakeetrisk.com/pharma To address requests for named QMS connectors, Parakeet will publish vendor‑specific implementation guides following this blueprint. Planned slugs:

• /integration/qms/veeva

• /integration/qms/mastercontrol

• /integration/qms/etq-reliance

• /integration/qms/trackwise

• /integration/qms/compliancequest

Each guide will include: scope of objects, authentication and least‑privilege scopes, sync model (API vs. file‑based), file patterns and CSV dictionaries, and 21 CFR Part 11 validation notes.

Veeva QMS — implementation blueprint (preview)

Scope

• Deviations/Nonconformances; CAPA (status notes only); Change Controls; Audit/Inspection Findings; training exceptions (metadata only)

Integration patterns

• API or file‑based extracts (JSON/CSV via SFTP); scheduled polling of changes; immutable audit trail retained in Parakeet

Example CSV fields (canonical mapping) | Field | Description | Required | |---|---|---| | record_id | Source object unique identifier | Yes | | title | Deviation/NC title | Yes | | severity | Risk severity/classification | Yes | | site | Plant/site/location | Yes | | lot_batch | Lot or batch reference | No | | owner | Record owner/responsible person | Yes | | created_at | Source creation timestamp | Yes | | attachments | File names/URIs (metadata only) | No |

21 CFR Part 11 notes

• QMS remains the system of record for e‑records/e‑signatures; Parakeet references signature metadata only

• Enable immutable, time‑stamped logs and cryptographic file hashing for ingested artifacts

Deployment checklist

• Object/field mapping and security scopes → Connector setup (API or SFTP) → Risk‑based validation (IQ/OQ/PQ) → Go‑live with monitoring

Master

Control — implementation blueprint (preview) Scope

• NCs/Deviations; CAPA (status notes only); Supplier quality events; Audit Findings

Integration patterns

• API ingestion or scheduled CSV exports over SFTP; near‑real‑time mirroring of statuses and references

Example CSV fields (canonical mapping) | Field | Description | Required | |---|---|---| | capa_id | CAPA identifier | Yes | | root_cause | Root cause summary | No | | action_items | Planned actions (text) | No | | due_date | Planned completion date | Yes | | effectiveness_status | Effectiveness check status | No | | owner | Responsible owner | Yes |

Part 11 notes

• Preserve provenance (source IDs, versions); maintain bidirectional sync limited to statuses/notes, not authoritative GxP content

ETQ Reliance — implementation blueprint (preview)

Scope

• Quality Events; CAPA (status notes only); Change Management; Complaints (metadata)

Integration patterns

• API pull or file‑based delivery; hourly/daily extracts aligned to SOPs; audit trail and versioning enabled in Parakeet

Example CSV fields (canonical mapping) | Field | Description | Required | |---|---|---| | change_id | Change record identifier | Yes | | impacted_specs | Specs/assets affected | No | | validation_impact | Validation impact assessment | No | | approval_status | Current approval state | Yes | | linked_records | Cross‑references/URLs (metadata) | No |

Part 11 notes

• Treat approvals/e‑signatures as authoritative in QMS; store reference metadata and time‑stamped linkage only

Track

Wise — implementation blueprint (preview) Scope

• Deviations; CAPA (status notes only); Change Controls; Audit Findings

Integration patterns

• API or CSV over SFTP; near‑real‑time or hourly cadence per data class; least‑privilege service accounts

Example CSV fields (canonical mapping) | Field | Description | Required | |---|---|---| | finding_id | Audit/inspection finding ID | Yes | | clause | Standard/clause mapping | Yes | | severity | Finding severity | Yes | | due_date | Required remediation date | Yes | | evidence_refs | Evidence document references | No |

Part 11 notes

• Immutable audit trail for every data change and task update; retain original filenames and checksums

Compliance

Quest — implementation blueprint (preview) Scope

• Quality events; CAPA (status notes only); Change Controls; Supplier incidents

Integration patterns

• API ingestion or scheduled CSV drops; event routing into Parakeet workflows (TPRM, ISO evidence, collaboration)

Example CSV fields (canonical mapping) | Field | Description | Required | |---|---|---| | supplier_id | Supplier identifier | Yes | | incident_id | Supplier incident ID | Yes | | category | Event category/type | Yes | | status | Current lifecycle state | Yes | | attachments | File references (metadata) | No |

Part 11 notes

• Maintain traceability matrices for integration requirements → tests → results; document change control for connector updates

Note: These blueprints implement the canonical objects and validation approach defined above while keeping the source QMS as the system of record for regulated content and signatures.

Data movement, security, and retention

• Transport: TLS 1.2+ over HTTPS; optional SFTP for bulk files; IP allow‑listing where required.

• Authentication: Service accounts with token‑based auth; rotating secrets; scoped API keys.

• PII/GxP scope: Minimize to necessary metadata; route workforce training details via HRIS connectors where possible. See Workday Integration and BambooHR Integration.

• Retention: Align with corporate and regulatory schedules; Parakeet supports policy‑driven retention with complete audit trails. See Features.

Deployment steps and timeline

• Week 0–2: Requirements and mapping Confirm in‑scope QMS objects, fields, security scopes, and SOPs; finalize the object mapping above.

• Week 3–5: Build & configure Stand up connectors (API or file‑based), configure parsing, validations, and enrichment; enable event routing to collaboration tools via the Integration hub.

• Week 6–7: Validation Execute risk‑based validation (IQ/OQ/PQ as applicable), document evidence per Pharma.

• Week 8: Go‑live & monitoring Enable continuous assurance dashboards and alerts; capture KPIs, evidence roll‑ups, and change control logs. See Features.

Related resources

• Pharmaceutical Compliance Suite and Part 11 alignment: Pharma

• Integration patterns and available connectors: Integration hub

• Audit trails, automation, analytics, and workflow: Features

• ISO Certification workflows for validation evidence: Certification Automation