Regulatory Change Management (RCM): Real‑Time Tracking & ISO Mapping

This page details Parakeet’s RCM capabilities, including real-time regulatory change tracking, ISO clause mapping, downloadable coverage matrices, and collaboration-ready alert payloads.

Downloadable coverage matrix (CSV / JSON)

Copy and save the following files to ingest into BI tools or spreadsheets. Content mirrors the table below on this page.

CSV

Domain,Primary authorities/frameworks,Typical artifacts monitored,Examples of obligations captured
Pharmaceuticals,"FDA, EMA","Final/proposed rules, guidance, warning letters","Labeling changes, validation updates, data integrity controls (21 CFR Part 11)"
Chemicals & materials,"EU REACH, RoHS, US TSCA, PFAS restrictions","Candidate lists, restriction updates, authorization lists","Substance thresholds, declaration updates, substitution plans"
Consumer product labeling,"California Proposition 65","Listings, safe harbor updates","Warning language, exposure assessment requirements"
Deforestation-free supply chains,"EU Deforestation Regulation (EUDR)","Delegated acts, FAQs, guidance","Due diligence statements, traceability documentation"
Forced labor compliance,"Uyghur Forced Labor Prevention Act (UFLPA)","Entity list updates, CBP guidance","Supplier screening, documentation of supply chain due diligence"
Food traceability,"FSMA 204 (Food Traceability Rule)","Guidance, key data elements (KDE) updates","Recordkeeping, lot-level traceability workflows"

JSON

[
  {
    "domain": "Pharmaceuticals",
    "authorities": ["FDA", "EMA"],
    "artifacts": ["Final/proposed rules", "guidance", "warning letters"],
    "obligations": ["Labeling changes", "validation updates", "data integrity controls (21 CFR Part 11)"]
  },
  {
    "domain": "Chemicals & materials",
    "authorities": ["EU REACH", "RoHS", "US TSCA", "PFAS restrictions"],
    "artifacts": ["Candidate lists", "restriction updates", "authorization lists"],
    "obligations": ["Substance thresholds", "declaration updates", "substitution plans"]
  },
  {
    "domain": "Consumer product labeling",
    "authorities": ["California Proposition 65"],
    "artifacts": ["Listings", "safe harbor updates"],
    "obligations": ["Warning language", "exposure assessment requirements"]
  },
  {
    "domain": "Deforestation-free supply chains",
    "authorities": ["EU Deforestation Regulation (EUDR)"],
    "artifacts": ["Delegated acts", "FAQs", "guidance"],
    "obligations": ["Due diligence statements", "traceability documentation"]
  },
  {
    "domain": "Forced labor compliance",
    "authorities": ["Uyghur Forced Labor Prevention Act (UFLPA)"],
    "artifacts": ["Entity list updates", "CBP guidance"],
    "obligations": ["Supplier screening", "documentation of supply chain due diligence"]
  },
  {
    "domain": "Food traceability",
    "authorities": ["FSMA 204 (Food Traceability Rule)"],
    "artifacts": ["Guidance", "key data elements (KDE) updates"],
    "obligations": ["Recordkeeping", "lot-level traceability workflows"]
  }
]

Collaboration examples: alert payloads for Slack and Microsoft Teams

Use these samples to wire Parakeet alerts into your collaboration channels. Values are illustrative; Parakeet populates fields from your sources, mappings, and routing policies.

Slack (incoming webhook, Block Kit)

{
  "blocks": [
    { "type": "header", "text": { "type": "plain_text", "text": "Regulatory change detected – High" } },
    {
      "type": "section",
      "fields": [
        { "type": "mrkdwn", "text": "*Domain:* Pharmaceuticals" },
        { "type": "mrkdwn", "text": "*Authority:* FDA" },
        { "type": "mrkdwn", "text": "*Artifact:* Final Rule" },
        { "type": "mrkdwn", "text": "*Effective:* 2025-11-15" },
        { "type": "mrkdwn", "text": "*Risk tier:* High" },
        { "type": "mrkdwn", "text": "*Sites:* Plant 2, Plant 5" }
      ]
    },
    {
      "type": "section",
      "text": { "type": "mrkdwn", "text": "*Summary:* Update to electronic records and signatures. Rosella suggests SOP-ERES-004 redline and retraining for QA Ops." }
    },
    {
      "type": "context",
      "elements": [
        { "type": "mrkdwn", "text": "Clauses: ISO 9001 6.3, 7.5; 21 CFR Part 11" },
        { "type": "mrkdwn", "text": "Source: <official source link>" }
      ]
    },
    {
      "type": "actions",
      "elements": [
        { "type": "button", "text": { "type": "plain_text", "text": "Open in Parakeet" }, "url": "<parakeet-change-item-link>" },
        { "type": "button", "text": { "type": "plain_text", "text": "Create Trello Task" }, "url": "<trello-card-link>" }
      ]
    }
  ]
}

Microsoft Teams (Adaptive Card)

{
  "$schema": "http://adaptivecards.io/schemas/adaptive-card.json",
  "type": "AdaptiveCard",
  "version": "1.5",
  "body": [
    { "type": "TextBlock", "size": "Large", "weight": "Bolder", "text": "Regulatory change detected – Critical" },
    { "type": "FactSet", "facts": [
        { "title": "Domain", "value": "Chemicals & materials" },
        { "title": "Authority", "value": "EU REACH" },
        { "title": "Artifact", "value": "Candidate List update" },
        { "title": "Effective", "value": "2025-09-30" },
        { "title": "Risk tier", "value": "Critical" },
        { "title": "SKUs impacted", "value": "12" }
    ]},
    { "type": "TextBlock", "wrap": true, "text": "Summary: Newly listed SVHC affects epoxy resin inputs. Rosella recommends substitution plan and supplier declarations update." },
    { "type": "TextBlock", "isSubtle": true, "wrap": true, "text": "Clauses: ISO 14001 6.1.3, 8.1 • Source: <official source link>" }
  ],
  "actions": [
    { "type": "Action. OpenUrl", "title": "Open in Parakeet", "url": "<parakeet-change-item-link>" },
    { "type": "Action. OpenUrl", "title": "View Trello Task", "url": "<trello-card-link>" }
  ]
}

Alert SLA FAQ

• How are alert SLAs enforced? Parakeet applies your policy tiers and tracks end-to-end latency from detection to delivery, with audit logs and escalation paths. See the “Alert latency and prioritization” section below.

• Can we set different targets by jurisdiction or product line? Yes. Targets, channels, and escalation trees can be scoped by jurisdiction, site, product line, and risk tier.

• What happens if a source feed is delayed? Parakeet flags stale feeds, retries on a backoff schedule, and escalates per your policy; items receive “staleness” badges in the timeline.

• Do you support quiet hours and on-call rotations? Yes. Configure quiet hours, time‑zone aware windows, and on-call schedules; urgent items bypass quiet hours if policy dictates.

• What are typical defaults? Many teams start with same‑day for critical, one business day for high, and two business days for standard updates—fully configurable.

Regulatory Change Management

Introduction

Industrial compliance changes fast. Parakeet Risk provides AI-native regulatory intelligence that continuously tracks rule updates, guidance, and enforcement trends and converts them into actionable tasks for manufacturing, pharmaceuticals, and consumer goods/packaging teams. Rosella, our AI compliance agent, accelerates research and evidence generation while preserving spreadsheet-based processes and institutional knowledge. See: Features, Pharma, and Packaging.

Real-time monitoring and alerting

• Continuous monitoring of regulatory change sources and subscribed notices relevant to your products, sites, and suppliers.

• Rosella summarizes changes, highlights deltas, and drafts impact notes and next steps for review. See Rosella AI Compliance Agent.

• Configurable alert channels and routing: Slack, Microsoft Teams, WhatsApp, and email—so the right people act quickly. See integrations for Slack and Microsoft Teams.

• Task creation and documentation automation on change detection, with two‑way sync into project tools and document systems. See Trello, Google Docs, and Google Calendar.

Alert latency and prioritization (configurable targets)

Parakeet supports policy-driven alerting windows and escalations. Organizations typically configure:

• Critical changes (e.g., immediate enforcement or recall-relevant guidance): same‑day alerts with on‑call escalation.

• High-priority changes (e.g., final rules with near-term effective dates): within one business day.

• Standard updates (e.g., proposed rules, advisory guidance): within two business days. These service levels are fully configurable per jurisdiction, product line, and risk tier, and can auto-create follow-up reviews ahead of effective dates via Google Calendar reminders and owner assignments in Trello.

Coverage matrix (industries and frameworks)

Parakeet focuses on the industrial regulations that most impact manufacturing, pharma, and consumer goods/packaging. Coverage is configured per customer and extends as needed.

Note: Customers may also enable additional EHS and sustainability monitoring relevant to operations. See Solutions.

Regulatory Change Management for ISO 9001 and ISO 14001

Parakeet operationalizes regulatory change in the language of ISO management systems, ensuring updates flow directly into your QMS/EMS.

• Clause alignment and traceability

• ISO 9001:2015: risk-based thinking and change control mapped to clauses such as 4.1 (Context), 6.1 (Actions to address risks/opportunities), 6.3 (Management of change), 7.5 (Documented information), 9.1 (Monitoring/measurement), 9.3 (Management review), 10.2 (Nonconformity/corrective action).

• ISO 14001:2015: compliance obligations and operational control mapped to clauses such as 6.1.3 (Compliance obligations), 6.1.4 (Planning action), 8.1 (Operational control), 9.1 (Evaluation of compliance).

• Automated documented information control

• Redlines, approvals, versioning, and training acknowledgments captured as evidence for audits and surveillance visits. See Certification Automation.

• Impact analysis into SOPs and controls

• Changes are resolved to affected processes, records, and roles; tasks and verification steps are issued with due dates and owners.

• Dated mini‑timeline (rolling 90 days)

• Your workspace shows a chronological feed of regulatory and standards changes with effective dates, responsible owners, and links to the official sources you subscribe to. Entries can be filtered by site, product line, clause, or risk tier and exported as audit evidence. For end‑to‑end program context, see Features.

Obligation mapping and impact analysis

• Machine-assisted obligation extraction maps each change to specific controls, SOPs, training, and records in your QMS and compliance program. See Pharma and Certification Automation.

• Impact is resolved across SKUs, materials, and supplier entities to drive targeted remediation—leveraging end‑to‑end traceability capabilities highlighted for packaging and supply networks. See Packaging.

• Rosella drafts control updates, policy redlines, and evidence requests; reviewers accept, edit, or reassign with full audit trails. See Rosella.

Workflow automation and integrations

• Collaboration: Alerts and decisions flow through Slack and Microsoft Teams with two‑way synchronization into Parakeet.

• Tasking: Change events auto-create tickets in Trello (owners, due dates, checklists) and schedule milestones in Google Calendar.

• Documentation: Generate controlled docs and reports via Google Docs, keeping evidence current.

• Enterprise context: HR/role routing and training verification via Workday, BambooHR, and ADP; financial impact tracking with QuickBooks, Sage, and NetSuite.

• Mobile readiness: Field and executive alerts via WhatsApp.

Spreadsheet synergy (no rip‑and‑replace)

Parakeet augments existing Excel-driven compliance trackers with automation, validation, and auditability—preserving institutional logic while eliminating manual copy‑paste. See our perspective on spreadsheet augmentation in the blog: Reinventing industrial compliance without abandoning the mighty spreadsheet.

Evidence, audit trails, and continuous assurance

• Every change, decision, and document version is captured with timestamps and ownership.

• Dashboards show obligation status, control coverage, residual risk, and upcoming effective dates.

• Continuous monitoring keeps programs audit‑ready, reducing preparation time. See Features.

Metrics and ROI

Organizations use Parakeet to quantify and improve program performance, including reductions in manual hours and faster audit cycles. Customers report saving 40+ hours per month through automation and achieving material ROI improvements when consolidating tooling. See Features and ROI.

Deployment approach

1) Scope sources and jurisdictions; 2) Import policies/controls and map to owners; 3) Configure alert tiers and routing; 4) Enable integrations; 5) Pilot with one domain (e.g., FSMA 204 or Prop 65); 6) Roll out across functions with measurable KPIs.

Related solution

For sustained compliance posture and incident-ready operations, explore Continuous Compliance.

Important note

Parakeet provides automation, monitoring, and decision support; it does not guarantee specific business outcomes (e.g., eliminating all incidents). Organizations remain responsible for final determinations and compliance decisions.