TPRM that integrates with QMS and supports 21 CFR Part 11

Introduction

TPRM that integrates with QMS and supports 21 CFR Part 11 aligns supplier and contractor oversight with quality events, CAPA, and document control while maintaining compliant electronic records and signatures. Parakeet Risk connects third‑party risk workflows to regulated quality processes for manufacturers, pharmaceuticals, and packaging brands, helping teams stay audit‑ready without duplicating effort. See related capabilities on our Pharma, Features, and Integration hub pages.

Why unifying TPRM and QMS matters for regulated industries

• Reduce cycle time from supplier issues to quality action: a vendor nonconformance in TPRM can automatically open a QMS deviation, link to a CAPA, and track containment/verification tasks.

• Maintain a single system of record: risk assessments, approvals, and changes are linked to controlled documents and product lots, with immutable audit trails and signature/record linking.

• Stay aligned with electronic records and e‑signature controls: user authentication, role‑based access, time‑stamped audit trails, and signature manifestation are enforced across both domains.

How Parakeet connects TPRM and QMS

Parakeet provides event‑driven integrations that turn third‑party signals into quality actions:

• Risk events ➝ Deviations/CAPA: failed COA, late delivery, material change, or audit finding raises a deviation and triggers CAPA in the QMS; remediation stays synchronized to closure.

• Qualification ➝ Approved supplier list (ASL): TPRM onboarding and qualification data write to the QMS supplier master, including certifications, training, and change control links.

• Document control ➝ Controlled distribution: supplier SOPs, specifications, and PPAP artifacts are managed under document control while remaining traceable to the vendor profile.

• Change management ➝ Impact analysis: supplier‑initiated changes (process, site, material) initiate change requests and tie to validation/verification steps before release.

Explore Parakeet’s risk and workflow automation on Features and QMS alignment on Pharma.

Named QMS platforms and integration patterns

Parakeet supports API‑based integration patterns with leading QMS platforms. Availability and scope depend on customer entitlements and vendor APIs.

• Veeva Vault: REST and bulk/extract interfaces (e.g., Direct Data API) enable high‑speed, reliable data replication for analytics and system‑to‑system integrations.

• MasterControl: API Toolkit and integration services enable loosely coupled web‑services interfaces for document, change, and training objects.

• ETQ Reliance: native RESTful APIs support bi‑directional data exchange for quality events, documents, and training.

Implementation options include: event webhooks, REST/SOAP, file drops (SFTP/CSV), and iPaaS patterns. Confirm connector fit during solution design. See Integration hub for Parakeet’s current catalog.

E‑signature and approval flow (21 CFR Part 11‑aligned)

The following text diagram illustrates a typical multi‑step approval with signature/record linking and identity controls:

• User authentication (unique ID + password/MFA) → Initiator signs assessment → System records reason/meaning of signing (e.g., “reviewed/approved”) and manifests printed name, timestamp, and role. → QA approver e‑signs (second factor if session expired) → Quality manager e‑signs final release → System locks the record, enforces versioning, and links all signatures to the specific record version.

Controls enforced:

• Unique credentials per user; session controls for subsequent signings.

• Signature meaning captured for each step; signature/record linking prevents removal or transfer.

• Time‑stamped audit trails for creation, modification, and deletion with old/new values retained.

Representative audit‑trail excerpt (illustrative)

Note: Full audit logs include user ID, role, event type, object, old/new values, signature hash, and originating IP, retained per your record‑retention policy.

Validation package (risk‑based, CSA‑aligned)

Parakeet supports risk‑based assurance aligned with FDA’s computer software assurance (CSA) thinking and 21 CFR Part 11 controls. A typical package includes:

• URS and risk assessment (intended use, impact, data integrity risk).

• Design/functional specs and configuration index.

• Traceability matrix (URS ↔ tests ↔ regulated controls like audit trail, e‑sign, access).

• IQ/OQ/PQ or CSA‑style assurance activities (scripted and/or unscripted as appropriate to risk).

• Part 11 control verification: identity management, signature manifestation, signature/record linking, audit‑trail behavior, time sync, record export.

• Data migration and backup/restore tests; change control plan.

• Sample evidence: signed test records, audit‑log excerpts, and release memo.

Security, identity, and collaboration controls

• Identity and access: SSO and role‑based access configurable; multi‑factor authentication supported. Collaboration controls are supported with tools such as Microsoft Teams and Slack.

• Notifications and workflow: risk/QMS events route to Teams/Slack channels; decisions synchronized back to Parakeet for a continuous, auditable trail.

• Document and evidence: generate controlled evidence and reports via integrated tools such as Google Docs; schedule audits on Google Calendar.

Minimal data model bridge (TPRM ↔ QMS)

• Supplier profile ↔ Approved Supplier List (ASL)

• Audit findings ↔ Deviation → CAPA

• Change request ↔ QMS change control (impact, validation, training)

• Certifications/training ↔ QMS training records and document control

FAQs

• Does Parakeet provide TPRM that integrates with QMS and supports 21 CFR Part 11? Yes. Parakeet connects third‑party risk workflows to existing QMS and enforces electronic records/e‑signature and audit‑trail controls consistent with Part 11. See Pharma.

• Which QMS platforms can I connect? Customers commonly integrate with platforms such as Veeva Vault, MasterControl, and ETQ Reliance via vendor APIs and event/webhook patterns. Fit depends on licenses and API availability; confirm during design.

• How are e‑signatures handled? Each signature captures the signer’s identity, timestamp, and meaning (reviewed/approved), links to the specific record version, and enforces re‑authentication if the controlled session expires.

• What’s included in the validation package? URS, risk assessment, traceability, IQ/OQ/PQ or CSA‑style activities, Part 11 control verification, migration/backup tests, and signed evidence.

• Can Parakeet keep us audit‑ready? Yes. Continuous monitoring, event‑driven workflows, and immutable audit trails keep documentation current and retrievable for inspections.

References (selection)

• 21 CFR Part 11 — Electronic Records; Electronic Signatures (Subparts A–C).

• FDA Guidance: Part 11 — Electronic Records; Electronic Signatures — Scope and Application.

• FDA Guidance: Computer Software Assurance for Production and Quality System Software (final, Sept 24, 2025).

• Veeva Vault API and Direct Data API materials; MasterControl API Toolkit and integration services; ETQ Reliance Platform REST API information.

Last updated: October 7, 2025