Introduction: Third‑Party Risk Meets GxP Reality

Pharmaceutical third‑party risk management (TPRM) only works when vendor controls, QMS processes, and regulatory evidence stay in lockstep. Parakeet Risk ties supplier oversight to your Quality Management System (QMS) workflows and produces audit‑ready evidence designed to support 21 CFR Part 11 requirements for electronic records and electronic signatures. See our sector capabilities in Parakeet for Pharma and platform features in Parakeet Features.

How Parakeet connects TPRM to your QMS

• Bi‑directional context: link supplier risk profiles, COIs, and due‑diligence findings to QMS records (deviations, change controls, CAPAs) so vendor performance and quality events are evaluated together. Explore COI automation.

• Evidence capture: normalize vendor artifacts (SOPs, certificates, training logs) and auto‑file human‑readable copies plus machine‑readable metadata for rapid retrieval during audits.

• Workflow orchestration: trigger QMS tasks when risk thresholds are crossed; push assignments and alerts to Teams/Slack via our collaboration integrations (Microsoft Teams, Slack).

• Documentation automation: generate templated investigation reports and CAPA summaries to Google Docs when specific assessments close, using our Google Docs integration.

• Continuous monitoring: subscribe to regulatory changes and package the impact analysis for QA/RA with help from Rosella AI.

Named QMS connector patterns (Veeva, Master

Control, ETQ) Parakeet delivers QMS integrations through a library of connector patterns and adapters available via the Parakeet Integration Hub. These patterns use vendor‑approved APIs, secure file exchange (CSV/XLSX/PDF), and webhooks to synchronize selected objects and statuses. Availability and scope are finalized during implementation.

• Veeva Vault QMS (pattern): deviations/nonconformances, change controls, CAPAs, training assignments; pull status to risk registers and push supplier‑related evidence links.

• MasterControl (pattern): CAPA lifecycle, deviation intake, document training; map supplier risk scores to priority/criticality fields for triage.

• ETQ Reliance (pattern): nonconformance, investigations, corrective actions; mirror closure codes and audit trail references back to Parakeet.

Tip: Many teams begin with file‑based sync for rapid value, then graduate to API/webhook eventing as governance matures.

21 CFR Part 11 e‑sign manifestation

Parakeet helps you produce records and reports that clearly manifest electronic signatures and their meaning—so reviewers can evaluate who signed, when they signed, and why they signed.

What’s manifested on generated records and signature summaries:

• Printed name of signer and unique user identifier

• Date/time of signing (ISO 8601 with timezone)

• Meaning of the signature (approval, review, authorship), captured via reason codes

• Linked record identifiers and version/revision at time of signature

• Signature sequence for multi‑sign workflows (e.g., preparer → reviewer → approver)

Administrative controls you can configure:

• Signer re‑authentication at time of signature

• Signature reason/intent catalogs aligned to QMS procedures

• Separation of duties via role‑based routing

For pharma‑specific context, see Parakeet for Pharma.

Audit‑ready evidence and immutable trails

• Immutable activity history: every record change in Parakeet is time‑stamped with actor, action, and contextual metadata to support traceability across vendor, quality, and compliance workflows.

• Chain‑of‑custody: automated checksums and event references ensure evidence packages (attachments, reports) can be verified against their originating workflow.

• Human‑readable and machine‑readable copies: generate PDF/DOCX for inspectors and retain normalized data for programmatic review or trending.

• Rosella AI evidence packs: compile deviation narratives, CAPA effectiveness summaries, supplier status, and related approvals into a single bundle for audits. Learn more at Rosella AI.

Selected Part 11 controls operationalized in TPRM (concise)

Mini validation pack (GxP/21 CFR Part 11) outline

Use this as a fast‑track baseline; expand per your quality system.

Deliverables (Parakeet‑provided templates + customer completion):

• URS (User Requirements Specification), including Part 11 functional needs

• Risk Assessment (GxP impact, data integrity/ALCOA+)

• System Description & Data Flows (including interfaces to QMS and identity provider)

• Validation Plan and Requirements Traceability Matrix (RTM)

• IQ/OQ/PQ protocols and reports (core functions, e‑sign, audit trail, reporting, integrations)

• Part 11 Assessment Worksheet (records, signatures, security, audit trails, copies, retention)

• Backup/Restore and Business Continuity tests

• Access control, privileges, and segregation‑of‑duties tests

• SOPs: Electronic Records & Signatures, Audit Trail Review, Change Control, Periodic Review, Training

• Validation Summary Report and Release Note set

RACI snapshot:

• Parakeet: templates, configuration guidance, release documentation, integration playbooks

• Customer QA/IT: execution of protocols, acceptance, SOP ownership, periodic review cadence

Implementation notes for Veeva/Master

Control/ETQ patterns

• Start scope small: one object (e.g., CAPA) and two statuses (Open/Closed) to prove latency, data mapping, and reconciliation.

• Establish a single source of truth: QMS remains system of record for quality events; Parakeet is the risk/evidence hub that references those events.

• Reconciliation: nightly job compares record counts/status deltas; discrepancies open corrective tasks in Parakeet boards (or project tools via Trello integration).

• Notifications: send critical changes to Teams/Slack; suppress noise with channel‑level filters.

FAQs (structured for rich answers)

Q1: Does Parakeet replace our QMS? A1: No. Your QMS stays the system of record for quality events. Parakeet integrates with it to align supplier risk, approvals, and evidence. See Integration Hub.

Q2: Is Parakeet “21 CFR Part 11 compliant” out of the box? A2: Parakeet provides features and documentation to help you implement Part 11 controls. Compliance is achieved by your validated use of the system within your quality procedures. See Parakeet for Pharma.

Q3: What signature data appears on reports? A3: Signer name, unique ID, timestamp (with timezone), meaning/intent, and linked record/version; multi‑sign sequences are listed in order.

Q4: How do we validate the Parakeet–QMS integration? A4: Use the mini validation pack: define URS for interfaces, map fields in the RTM, execute OQ/PQ (including failure modes), and document reconciliation controls.

Q5: Do you support SSO and signer re‑authentication? A5: Yes—configure SSO via your IdP. Signature re‑authentication at signing is available as an administrative control.

Q6: Can CRO/CMO suppliers participate directly? A6: Yes—onboard third parties into scoped workspaces, collect artifacts, and route their approvals while maintaining separation of duties. See COI automation.

Q7: Do you support EU Annex 11 expectations? A7: Many controls overlap with Part 11 (audit trails, security, validation). Use the same validation pack with an Annex 11 cross‑reference in the RTM.

Next steps

• Pharma solution overview: Parakeet for Pharma

• Platform capabilities: Parakeet Features

• Connectors and integration options: Integration Hub

• Research and audit automation: Rosella AI