Purpose
1. Automate the monitoring and syncing of updates from national and international regulatory databases affecting pharmaceutical compliance.
2. Automatically detect, parse, and distribute legislative changes, FDA/EMA rule amendments, product recalls, and regulatory bulletins to compliance teams.
3. Automating the aggregation, classification, and escalation of new compliance requirements throughout documentation systems, ensuring full regulatory traceability.
4. Automate periodic checks, consolidate compliance reports, and trigger timely audits, ensuring all manufacturing procedures align with the latest automated updates.
Trigger Conditions
1. New document or update posted on regulatory authority (e.g., EMA, FDA, MHRA, CDSCO) databases or RSS feeds.
2. Automated changes in keyword-specific compliance search results on regulatory portals.
3. Scheduled trigger for daily/weekly scans of all relevant regulatory sources.
4. Webhook activations from regulatory partners or automated API event callbacks.
Platform Variants
1. Microsoft Power Automate
• Feature/Setting: Use HTTP action and RSS trigger to automate API calls or feed monitoring to FDA and EMA update feeds.
2. Zapier
• Feature/Setting: Automate parsing new items in regulatory RSS feeds; filter by keywords, trigger Gmail/Slack delivery.
3. Integromat (Make)
• Feature/Setting: HTTP module with scheduled automation for GET requests to regulatory endpoints; connect to Docs/Sheets.
4. AWS Lambda
• Function: Automate custom Node.js/Python script, triggered by CloudWatch Events to call FDA API and push updates to S3.
5. Google Cloud Functions
• Function: Triggered via Pub/Sub or scheduler, automating FDA/EMA endpoint polling, storage in Google Sheets/BigQuery.
6. Twilio SendGrid
• Feature: Automated regulatory alert email via SendGrid API when updates detected; dynamic email templates for compliance.
7. Slack API
• Feature: Automate push notifications to compliance channels using chat.postMessage for every new regulatory alert.
8. Salesforce
• Setting: Automate integration using Salesforce Flow to inject regulatory alerts into record updates or Chatter.
9. Smartsheet
• Feature: Automated row addition or update using Smartsheet API when new regulatory info is parsed.
10. Trello
• Feature: Automate new card creation via Trello API with parsed regulatory requirements, assigned to compliance staff.
11. DocuSign
• Setting: Automatic sending of compliance documents for electronic signature after regulatory update triggers a workflow.
12. ServiceNow
• Feature: Automate incident ticket creation via ServiceNow API for regulatory events matched to risk criteria.
13. Jira
• Feature: Automatically create/update issues in Jira using REST API with parsed regulatory change details.
14. Confluence
• Feature: Automate the creation of alert pages using Confluence API to disseminate compliance changes.
15. Monday.com
• Setting: Automate item update and team notification using Monday API when regulation feed detects change.
16. IBM Watson Discovery
• Function: Automate document ingestion, keyword extraction, and compliance mapping with API-driven workflow.
17. Box
• Feature: Automatedly save regulatory XML/PDF updates in Box folder via API upon trigger detection.
18. SharePoint
• Setting: Automate upload & metadata tagging of regulatory updates using SharePoint REST API.
19. Google Drive
• Feature: Automate regulatory document storage with folder hierarchy using Drive API.
20. Notion
• Setting: Automate new page creation under ‘Compliance Alerts’ database with parsed regulatory content using Notion API.
Benefits
1. Automate early-detection and escalation, reducing regulatory breach risk.
2. Automated traceability and compliance documentation for audits.
3. Automator eliminates manual checks, boosting productivity & focus on value tasks.
4. Automation ensures all teams are consistently informed with the latest regulatory information, reducing compliance delays.
5. Automated reporting and archival processes streamline compliance program reviews.
Regulatory Compliance and Documentation Automations