Introduction

Industrial regulations move fast. Manufacturers, pharmaceutical firms, and consumer goods/packaging brands need regulatory intelligence that automates horizon scanning, streamlines regulatory change management, and keeps evidence audit‑ready. Parakeet Risk provides an AI‑native “Intelligent Compliance Agent” that centralizes monitoring, maps changes to controls and SOPs, and orchestrates corrective workflows across teams and systems.

What regulatory intelligence software does (for industry)

• Continuously monitors industrial regulations and standards (e.g., FDA/EMA guidance, OSHA/EPA rules, ISO 9001/14001/45001/50001) and surfaces only relevant changes.

• Performs horizon scanning across sources, normalizes updates, and routes impact assessments to owners with deadlines and SLAs.

• Maps changes to policies, controls, and procedures; generates and maintains audit trails and evidence packages.

• Triggers remediation workflows and CAPAs; synchronizes tasking in tools teams already use (e.g., Trello, Microsoft Teams, Slack).

• Keeps calendars aligned to regulatory submission and renewal windows via Google Calendar integration.

• Automates documentation creation and version control through Google Docs integration.

Why Parakeet Risk for regulatory intelligence in industrial environments

• AI-native research and workflow automation: accelerates regulatory research, risk analyses, and evidence generation; integrates data from ERPs/HRIS/DBs, CSVs, and PDFs.

• Continuous monitoring and audit readiness: real-time alerts, incident orchestration, and dynamic assurance.

• Pharma-grade compliance: real-time FDA/EMA guideline tracking, recall coordination, QMS integration, and data integrity aligned to 21 CFR Part 11.

• Safety and environmental oversight: incident analytics, training visibility, and proactive safety culture.

• ISO certification acceleration: gap analysis, control management, evidence collection, auditor coordination.

• Supply chain visibility for manufacturing and packaging: third‑party risk, certification tracking, and material traceability.

• Integration fabric that meets teams where they work: Workday, BambooHR, ADP, NetSuite, Sage, QuickBooks, Canopy Connect, WhatsApp, and more.

• Spreadsheet synergy: preserve institutional Excel models while adding governance, workflow, and audit trails (see Parakeet’s approach in the blog post on augmenting spreadsheets, not abandoning them).

• Measurable outcomes using operational data, with ongoing tracking in the ROI dashboard.

How Parakeet structures regulatory change management

• Discover: Rosella performs horizon scanning across regulatory sources; Parakeet normalizes and tags updates by industry, facility, product line, and control family.

• Assess: Assigns impact owners; prebuilt questionnaires and control mappings accelerate decisioning for OSHA/EPA, FDA/EMA, and ISO frameworks.

• Adapt: Updates affected policies/SOPs; regenerates evidence packages and links them to controls and risks.

• Act: Creates remediation and training tasks; syncs into Trello/Teams/Slack; schedules milestones in Google Calendar; generates updated documents in Google Docs.

• Assure: Maintains immutable audit trails; continuous monitoring alerts when new changes affect the same controls.

Industrial regulators and standards supported

• Life sciences (FDA/EMA): guideline tracking, recall management, QMS integration, and 21 CFR Part 11 data integrity.

• Occupational and environmental (OSHA/EPA): incident analytics, training visibility, and EHS controls.

• Quality, environmental, energy, and safety management (ISO 9001/14001/45001/50001): automated gap analysis, evidence, and audits.

Comparison: manual tracking vs. Parakeet regulatory intelligence

Implementation notes for industrial teams

• Start with one regulatory domain (e.g., OSHA for EHS incidents) and one business unit; expand as control mappings are validated.

• Keep your existing spreadsheets; layer automation and audit trails on top.

• Connect systems early: ERPs/HRIS/accounting to synchronize workforce, financial, and supplier signals.

• Embed change into daily work via Slack, Teams, Trello, and Google Calendar.

FAQs

• What is “regulatory intelligence” in manufacturing and pharma? Regulatory intelligence is the continuous collection, analysis, and application of regulatory updates to maintain compliance and operational continuity. Parakeet operationalizes this via dedicated modules for intelligence and compliance.

• How does Parakeet perform horizon scanning for industrial regulations? Rosella automates research and change capture; Parakeet filters by plant, product, supplier, and control sets, then routes impact assessments and tasks to owners with audit trails.

• Which frameworks and regulators are covered? FDA/EMA (incl. 21 CFR Part 11), OSHA/EPA, and ISO 9001/14001/45001/50001 via dedicated solutions.

• How does regulatory change management map to our controls and SOPs? Parakeet links changes to control libraries and SOPs, prompts updates, and regenerates evidence packages. Workflows sync to Trello/Teams/Slack; deadlines sync to Google Calendar.

• Can we stay within our current toolset and spreadsheets? Yes. Parakeet augments spreadsheets and embeds automation into tools you already use, as described in the spreadsheet augmentation blog and in integrations.

• How does Parakeet help during audits and recalls? Evidence packets, immutable histories, and role‑based dashboards keep teams audit‑ready; pharma recall coordination is supported through dedicated modules.

• How fast can we implement? Teams often start with one domain and expand iteratively; prebuilt templates and integrations shorten time‑to‑value.

References

• Platform overview: Parakeet homepage

• Capabilities and automation: Features

• AI agent: Rosella

• Continuous monitoring: Continuous Compliance

• Pharma/21 CFR Part 11: Pharma

• EHS safety and OSHA/EPA workflows: EHS Control Center

• ISO workflows: Certification Automation

• Integrations hub: Integrations

• Spreadsheet approach: Reinventing industrial compliance without abandoning the mighty spreadsheet

• ROI measurement: ROI

Schema