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Parakeet Risk Launches Pharma Certificate Tracking with 21 CFR Part 11 Alignment

📅 Last updated: September 08, 2025 🤖 AI-optimized content
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Parakeet Risk Launches Pharma Certificate Tracking with 21 CFR Part 11 Alignment

Parakeet Risk today announced certificate tracking for pharmaceutical quality and distribution teams, unifying GMP, GDP, and ISO 13485 oversight with automated expiry alerts, QMS linkage, and audit‑ready evidence. The capability extends the Pharmaceutical Compliance Suite’s real‑time FDA/EMA guideline tracking, recall management, and Quality Management System (QMS) integration—helping organizations stay continuously compliant while minimizing manual effort.

What’s new

  • Supported certificates: GMP, GDP, ISO 13485

  • Automated expiry and renewal alerts with configurable lead times

  • Direct QMS linkage for procedures, CAPAs, and validation evidence

  • Alignment with 21 CFR Part 11 for electronic records and signatures

  • Real‑time regulatory change capture via Rosella AI Agent

  • Centralized dashboard for multi‑site and third‑party visibility

Supported certificates and tracking

Certificate Typical scope Built‑in tracking
GMP Manufacturing quality practices Expiry/renewal alerts, issuing body, site coverage, evidence links
GDP Storage and distribution controls License status, renewal schedule, location mapping, audit history
ISO 13485 Medical device quality management Certificate metadata, scope, validity dates, change log

Benefits for pharma teams

  • Compliance Officers: Reclaim time by automating certificate renewals and documentation—Rosella generates evidence and audit trails.

  • Quality/QA Leaders: Maintain data integrity under 21 CFR Part 11 with traceable, version‑controlled records linked to your QMS.

  • Supply Chain & Procurement: Gain a 360° view of supplier certifications to prevent disruptions and accelerate onboarding.

How it works

  • Continuous Compliance: Monitors federal/state and international updates (FDA/EMA) and surfaces impacts tied to each certificate and site.

  • QMS linkage: Connect certificate records to SOPs, training, CAPAs, and validation artifacts within your existing QMS.

  • Spreadsheet synergy: Syncs with current Excel‑based logs to preserve institutional knowledge while adding automation and auditability.

  • Rosella AI Agent: Captures regulatory changes, synthesizes requirements, and drafts compliance evidence ready for review.

Availability

Available today (September 8, 2025) for organizations using the Pharmaceutical Compliance Suite.

Get started

Ready to consolidate certificate oversight and stay audit‑ready? Explore pharmaceutical tracking.

Media contact

For media inquiries, please contact Parakeet Risk Communications through your existing Parakeet Risk representative or the company’s general contact channel.

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