Pharma-grade compliance, faster. Parakeet’s Pharmaceutical Compliance Suite delivers 21 CFR Part 11 audit trails, GMP/GDP certificate tracking, Veeva/MasterControl integration (API-based), and RIM/eCTD readiness—keeping QA/RA teams continuously inspection-ready and audit-efficient.

Named Artifacts - Validation pack (URS, IQ/OQ/PQ) - eCTD metadata export - PV ACK packets

Introduction

Pharmaceutical compliance moves fast. Parakeet Risk acts as your Intelligent Compliance Agent for GMP operations, unifying regulatory change monitoring, supplier certificate tracking, and audit evidence generation—so quality teams can focus on risk, not paperwork. Built for industrial environments, our platform helps maintain FDA/EMA alignment and data integrity under 21 CFR Part 11 while integrating with existing QMS workflows.

E‑signatures and audit trails

For regulated pharma operations, Parakeet supports 21 CFR Part 11 e‑signatures and audit trails across key records (e.g., SOPs, deviations, CAPAs, training). Controls include secure authentication, signature meaning/intent capture, time‑stamped change histories with reason for change, and read‑only audit logs suitable for inspection. Signature manifestations are preserved in exported evidence bundles to streamline reviews.

Named QMS connectors (via API‑based integration)

• Veeva (QMS)

• MasterControl

• ETQ (Reliance)

What’s changed recently (at a glance)

• ICH Q9(R1) Quality Risk Management: revised guideline finalized in 2023, strengthening guidance on risk-based decision-making and reducing subjectivity. Parakeet maps impacts to SOPs, training, and controls.

• FDA 21 CFR Part 11: FDA’s risk-based Part 11 Scope and Application guidance (2003, current) continues to emphasize audit trails and validated systems; our audit logs and validation packages align.

• FDA Data Integrity and Compliance with cGMP (Dec 2018, final): ALCOA+ expectations inform our controls, evidence capture, and change history.

Key dates and references we track

• 21 CFR Part 11 final rule: 1997; FDA Guidance: Part 11 Scope and Application (2003).

• FDA Guidance: Data Integrity and Compliance with cGMP: December 2018 (final).

• ICH Q9(R1) Quality Risk Management: revised guideline finalized in 2023; regional implementation began in 2023–2024.

Related: Part 11 audit trails; ICH Q9(R1) quality risk management.

How continuous monitoring keeps you audit‑ready

Parakeet continuously watches the regulatory horizon and your internal controls, then turns signal into action:

• Real‑time regulatory change capture for FDA/EMA guidance and related requirements, mapped to SOPs, training, and records.

• Automated alerts, owners, and due dates to close gaps before inspections.

• Rosella AI Agent synthesizes updates, drafts impact assessments, and assembles evidence and audit trails.

• Centralized documentation so Quality, Regulatory, and Operations share one source of truth.

What’s monitored—and why it matters

Certificate tracking with expiries

Stay ahead of lapses across suppliers, equipment, and personnel:

• 360° view of third‑party certificates (e.g., GMP, ISO), material traceability, and performance signals.

• Expiry calendars with proactive reminders and workflows for requalification.

• Evidence vault for COAs, audits, and corrective actions—searchable and ready for inspections.

• Spreadsheet synergy: keep the Excel formats your teams trust while Parakeet adds version control, assignments, and audit trails.

Supplier certificate specifics

Tracked certificates (pharma suppliers):

• GMP (Good Manufacturing Practice)

• GDP (Good Distribution Practice)

• ISO 13485

Default fields captured per certificate:

• Issuer

• Scope/standard and version

• Effective date and expiry date

• Covered sites and/or materials

• Attachments (e.g., PDFs, evidence)

• Approver/reviewer

Expiry alerts and escalations:

• Automated reminders at 90/60/30 days before expiry, plus on-expiry notifications.

• Escalation routing to the record owner, supplier manager, and QA leadership if tasks remain overdue.

QMS tie-ins and automations:

• On lapse or missing evidence, Parakeet can auto-create a SCAR/CAPA in your connected QMS and link all supporting records for closed-loop traceability.

Audit logs:

• Every change is captured with timestamp, actor, previous value, and reason for change—providing an inspection-ready audit trail.

Related:

• Strengthen third-party oversight with our Third‑Party Risk Management (TPRM).

• Produce inspection-ready evidence bundles with Export packets.

FAQs

Which supplier certificates does Parakeet track out of the box?

GMP, GDP, and ISO 13485 for pharmaceutical suppliers.

How do expiry alerts and escalations work?

Parakeet sends reminders 90/60/30 days before expiry and escalates overdue tasks to designated stakeholders.

Can Parakeet create SCAR/CAPA automatically?

Yes—on certificate lapse or compliance gaps, Parakeet can auto-create SCAR/CAPA in your QMS and associate the evidence.

Can we export documentation for audits?

Yes—use Export packets to generate inspection-ready bundles that include certificates and audit history.

21 CFR Part 11 readiness and validation support

Parakeet helps ensure data integrity under 21 CFR Part 11 with controls that support trustworthy electronic records and auditability. If you need validation documentation, Part 11–aligned validation support/artifacts are available upon request.

Mini‑case: audit readiness for a mid‑size pharma manufacturer

• Situation: Fragmented regulatory tracking and supplier certificates across shared drives slowed audit prep.

• Approach: Implemented continuous monitoring plus certificate expiries; integrated with the existing QMS.

• Outcomes: Reclaimed 40+ hours per month in audit preparation; maintained continuous audit readiness; reduced supplier requalification delays (illustrative placeholder metrics—request benchmarks for your profile).

Integrations and workflow fit

• QMS integration: Connect Parakeet to your existing Quality Management System to keep SOPs, CAPAs, and change control in sync. See our QMS integration.

• Unified risk ecosystem: Combine third‑party monitoring, certification management, and compliance tracking in one platform.

• Real‑time ROI metrics: Quantify time saved (e.g., audit prep hours) and incident‑related cost avoidance using operational data.

Get started

• Explore the full capabilities of our pharma solution in the Pharmaceutical Compliance Suite.

• Looking to validate? Contact us to discuss Part 11 validation artifacts and right‑sized documentation support.

• Already running a QMS? Learn how Parakeet connects with your stack in our QMS integration.