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Regulatory Change Management Software

Introduction

Parakeet Risk’s Regulatory Change Management (RCM) gives industrial teams a precise, always‑on way to track, triage, and operationalize regulatory changes across safety, environmental, quality, and pharma contexts. It couples real‑time alerts with workflow automation and audit‑ready evidence so manufacturers, pharma organizations, and consumer goods/packaging brands can act quickly without adding manual overhead. See real‑time regulatory alerts and automation on the Parakeet homepage and Features, and pharma‑specific FDA/EMA tracking on Pharmaceutical Compliance.

Scope and coverage model

The matrix below shows the core jurisdictions and authorities RCM is designed to monitor for industrial use cases. Authorities listed are representative examples; actual feeds and depth depend on your subscription and risk profile.

Jurisdiction Authorities (examples) Supported industrial use cases Source
US Federal OSHA, EPA, FDA (rules, guidance, enforcement, notices) EHS obligations (permit, reporting, incident), environmental programs, quality and product safety, recalls EHS context: EHS Safety; FDA/EMA tracking: Pharma; real‑time alerts: Features
US States + D.C. State OSHA plans, environmental quality departments, health agencies (e.g., permit updates, state‑level adoption/variance) 50‑state policy alignment, site‑level obligations, permit calendars, contractor/vendor requirements Real‑time alerting & automation: Homepage; Features
European Union EMA guidance/updates; member‑state competent authorities (national implementation signals) Pharma QA/QMS, labeling changes, PV signals, change control routing EMA coverage within pharma: Pharma

Note: “Authorities (examples)” is illustrative. Parakeet configures sources to your compliance scope during onboarding.

Update cadence and SLA (reference policy)

This reference SLA is a recommended baseline many teams adopt when configuring Parakeet RCM. It can be tuned by regulator, product line, or site.

  • Discovery scans: Daily horizon scanning across subscribed sources; incremental checks during business hours for fast‑moving authorities.

  • Critical (safety, recall, binding rule with immediate effect): Same‑day push to designated channels, with executive escalation and on‑call rotation.

  • High (effective <30 days, material control impact): Notification within 24 hours; remediation task creation and owner assignment.

  • Medium (proposed rules, guidance drafts, consultations): Digest within 3 business days; watchlist and comment windows tracked.

  • Low (editorial/format updates): Weekly digest; no tasks unless controls are implicated.

  • Auditability: Every alert carries a source URL, retrieval timestamp, message hash, and a synchronized evidence artifact (see Google Docs integration).

Alert delivery and collaboration channels

Operationalize changes where teams already work. Parakeet supports two‑way collaboration and deadline assurance through native integrations:

  • Slack: Real‑time alerts to channels with field triage and decision logging; two‑way sync to Parakeet records. Slack integration

  • Microsoft Teams: Route alerts to Teams channels; assign owners and due dates; sync decisions back to Parakeet. Teams integration

  • Trello: Auto‑create cards for regulatory changes with labels, checklists, and due dates mapped to your boards. Trello integration

  • Google Calendar: Publish compliance milestones (effective dates, comment deadlines, audits) to calendars with automatic updates. Google Calendar integration

How RCM works end‑to‑end

1) Scope definition: Import your authority list, products, sites, and obligations; connect ERPs/HRIS/Docs as needed via Integrations. 2) Horizon scanning: Parakeet continuously monitors subscribed regulators and sources; pharma teams can include FDA/EMA feeds per Pharma. 3) AI analysis: The Rosella AI Agent classifies impact (Critical/High/Medium/Low), maps changes to your controls, and drafts evidence and impact notes. 4) Workflow & delivery: Alerts flow to Slack/Teams; tasks/cards sync to Trello; deadlines land in Google Calendar. 5) Evidence & audit: Parakeet generates auditable memos and change‑log documents in your workspace via Google Docs integration. Continuous readiness is supported by Features and Continuous Compliance.

Horizon Scanning Alerts

Horizon Scanning Alerts are configurable, real‑time notifications triggered by regulator activity that matches your scope (authority, topic, product, site) and threshold. They are optimized for industrial teams that need immediate, contextualized action:

  • Policy routing: Map regulators to business owners; critical updates escalate with executive mentions (Slack/Teams).

  • Impact mapping: Rosella proposes impacted controls, SOPs, and records based on your GRC taxonomy. Features

  • Task creation: Generate Trello cards or internal tasks with prefilled checklists and due dates aligned to effective or comment deadlines. Trello integration

  • Evidence and traceability: Auto‑produce a change summary and attach the primary source for audit trails. Homepage

What’s new (2025)

As of October 21, 2025, organizations standardizing on Parakeet for RCM are emphasizing:

  • Channel‑first operations: Deeper Slack/Teams usage for same‑day critical pushes and decision logging. Slack · Teams

  • Board‑driven remediation: Trello cards for every High/Critical change with owner, checklist, and due date templating. Trello

  • Deadline assurance: Regulatory milestones are mirrored to Google Calendar for planners and plant managers. Google Calendar

  • Pharma focus: FDA/EMA guidance tracking tied to QMS change control via Rosella summaries. Pharma · Rosella

Related industrial solutions

  • EHS Control Center for safety programs and incident analytics. EHS Safety

  • ISO Certification Automation for ISO 9001/14001/45001/50001 workflows. Certification Automation

  • Manufacturing resilience with supply‑chain risk and continuous compliance. Manufacturing

Why Parakeet for RCM

  • Industrial‑specific AI: Rosella understands pharma, manufacturing, and packaging contexts to reduce analyst toil. Rosella

  • Spreadsheet synergy: Preserve existing Excel/Docs knowledge while adding automation and audit trails. Features

  • Unified risk ecosystem: Connect HRIS/ERP/Docs/Comms to keep RCM decisions visible and auditable. Integrations