Introduction

This page documents a reference architecture for connecting Parakeet Risk to Veeva Vault–based QMS environments. It focuses on integration patterns (API and file-based), data scope, security, and validation posture for regulated manufacturers and pharmaceutical organizations. This is an integration blueprint, not an endorsement or partnership statement.

What the integration enables

• Centralize quality and compliance signals in Parakeet while Veeva Vault remains the system of record for GxP content and quality processes.

• Automate risk/compliance workflows: incident triage, CAPA follow-up, audit readiness, supplier oversight, and ISO evidence packaging using Rosella AI Agent and Continuous Compliance.

• Maintain traceability and audit trails by linking Parakeet tasks and findings to originating Veeva records, supporting regulated operations described on our Pharmaceutical Compliance Suite.

Data scope and object mapping (reference)

The following objects are commonly synchronized. Actual scope is finalized during discovery.

Integration patterns

Parakeet supports multiple connectivity options to accommodate customer policies and validated-state constraints.

• API-driven synchronization

• Pull new/changed records on a schedule with delta windows; push permitted status updates back to Veeva only where governed by change control and customer policy.

• Supports field-level mapping, value normalization, and reference resolution (e.g., user, site, product, lot).

• Webhook/event-listener option where customer exposes event notifications to reduce polling.

• File-based interchange (validated-friendly)

• Scheduled exports from Veeva (reports or data extracts) delivered to a customer-controlled SFTP/secure bucket as CSV; Parakeet ingests with schema validations and audit trails.

• Document metadata sync via file manifests; document content remains in Veeva with deep links referenced in Parakeet.

• Hybrid

• API for light-touch lookups (e.g., user/site dictionaries) and file-based transfers for GxP objects where customers favor controlled, reviewable files.

For general platform connectivity and automation capabilities, see Features and Integrations.

Validation and compliance posture

• System of record: Veeva Vault remains authoritative for GxP records. Parakeet stores references, derived analytics, and workflow state that support operational risk/compliance management.

• Risk-based validation: We align to customer CSV/CSA approaches and provide configuration specs, test evidence, and traceability for the integration components (mapping docs, IQ/OQ-style tests where required).

• Audit trails and e‑signatures: Parakeet maintains immutable activity history for all ingestions, transformations, and user actions; where electronic signatures are required, they are executed in the system of record or according to customer SOPs described in our Pharma solution.

• Change control: All mapping/schema changes are versioned; releases are promoted through DEV/TEST/PROD with approvals and documented results.

Security and data protection

• Least-privilege access: Integration users are scoped to read-only datasets unless explicitly approved for controlled write-backs.

• Secrets management: Credentials/keys are stored in an encrypted vault; optional customer-managed secrets.

• Data in transit/at rest: TLS 1.2+ for transport; AES‑256 encryption at rest within Parakeet.

• Boundary minimization: Only metadata/fields required for risk and compliance workflows are ingested; document binaries can remain in Veeva with link-backs.

Deployment models

• Cloud-to-cloud connector: Parakeet-managed, with dedicated tenant isolation and customer-controlled IP allowlists.

• Customer-managed runner: Lightweight connector deployed in the customer’s environment to broker data to Parakeet, satisfying strict network egress policies.

Implementation phases and timelines (typical)

• Discovery and scoping (1–2 weeks): Object inventory, field mapping, SOP constraints, and validation plan.

• Build and configuration (2–4 weeks): Connectors, transformations, dashboards, and workflow automations in Parakeet.

• Validation and UAT (2–3 weeks): Test scripts, evidence capture, and approvals per customer CSV/CSA.

• Go‑live and hypercare (1–2 weeks): Monitoring, runbooks, and KPI baselining.

Operational monitoring and ROI

• Automated health checks: Job runtimes, record deltas, and schema drift alerts routed to Slack/Teams via our messaging integrations (Slack, Microsoft Teams).

• Continuous assurance: Real-time dashboards surface overdue CAPA actions, pending training, supplier certification gaps, and recall readiness supported by Continuous Compliance.

• Business value tracking: Quantify time saved and audit-readiness metrics using the ROI module.

FAQs

• Does Parakeet modify GxP records in Veeva? No. By default we operate read-only for GxP objects and write back only when explicitly approved and governed by customer change control.

• Can we run file-only integrations for validated systems? Yes. Many customers prefer SFTP/secure-bucket CSV exchanges with reviewable control files and signed deployment records.

• How do you handle schema changes? We version mappings, provide diff reports, and require approved promotions before deploying to production.

• Where do e‑signatures occur? In the system of record per SOP. Parakeet can route and verify completion as part of the workflow but does not replace regulated signing steps.

Next steps

• Book a discovery session to finalize object scope and validation needs via Contact.

• Explore related solutions for regulated manufacturing and pharma: Pharma, Manufacturing, and Certification Automation.