Compliance & Quality AssurancePurpose
1. Enable automated audit trail logging to record changes and approvals in real-time across all compliance and quality processes in the medical equipment manufacturing sector.
2. Automate traceability of modifications, with timestamps and user information for regulatory audits, ISO compliance, FDA inspections, and internal QA reviews.
3. Automatedly ensure historical records for product documentation, CAPA (Corrective and Preventive Action), supplier approvals, R&D documentation, and device design history files.
4. Automating evidence collection for discrepancy handling, with proper notification and accountability across all departments and users.
5. Automator triggers error reduction and enhances the speed of compliance investigations by maintaining continuous, immutable logs.
Trigger Conditions
1. Automate audit trail when document status changes (approved, rejected, revised).
2. Automating changelogs on updates to manufacturing protocols or device specifications.
3. Automated triggers when user permissions are modified.
4. Automating entries upon CAPA case creation, edits, or resolution.
5. Automated logging during device batch release or quality event documentation.
Platform Variants
1. Microsoft SharePoint
- Feature/Setting: Enable "Versioning Settings" in Document Library; configure "Audit Log Reports" for automated change capture.
2. SAP S/4HANA
- Function: Activate "Change Log" for Business Objects via configuration; automate notifications with "Workflow for Approvals".
3. Salesforce Health Cloud
- API: Enable "Field History Tracking" and "Setup Audit Trail" for medical data entities.
4. Veeva Vault QMS
- Feature: Automate "Audit Trails" module, ensure "Document Change Control" settings enabled.
5. Oracle NetSuite
- Function: Enable and automate "System Notes" for modification logs and approvals.
6. MasterControl
- Feature: Use "Audit Trail" API to log all workflow/document changes and approval steps.
7. Jira Service Management
- Feature: Configure "Issue History" and automate "Audit Log" plug-in for CAPA and documentation updates.
8. DocuSign
- API: Automate retrieval of "Envelope Audit Events" via REST API for signed compliance/quality docs.
9. Google Workspace (Drive, Docs)
- Feature: Enable "Activity dashboard" and "Audit log" APIs for automated change and sharing logs.
10. ServiceNow
- Setting: Enable "Audit" on tables; automate approvals and change tracking using "Business Rules".
11. Smartsheet
- Feature: Enable "Activity Log" and automate "Change History" widgets for compliance sections.
12. Monday.com
- Setting: Automate "Activity Log" visibility; configure webhook/triggers for automated audit trail entries.
13. GitHub
- API: Automate "Repository Audit Logs" for code, document, or design files.
14. Box
- API: Enable "Box Events" for automated folder/file change logs, approval workflows with webhooks.
15. Slack
- API: Automate "Audit Logs API" for workspace changes, message approvals, and compliance workflows.
16. AirTable
- Feature: Enable "Base History" and automate integration with "Record Auditing" blocks.
17. Adobe Sign
- API: Automate collection of "Audit Report" via REST for every signed/approved compliance document.
18. AWS CloudTrail
- Feature: Automate logging of S3, Lambda, and user activity for device-related regulatory filings.
19. IBM Maximo
- Feature: Enable "Audit Tracking" for asset logs; automate via "Workflow Designer" for approvals.
20. Zoho Creator
- Feature/API: Enable and automate "Audit Logs" for form submissions, approvals, and workflow updates.
Benefits
1. Streamlined, automated audit readiness for ISO, FDA, and MDR requirements.
2. Reduced manual effort with automated changelog and approval logging.
3. Automated transparency across teams; ensures accountability and compliance.
4. Accelerates audit response times via comprehensive, automated records.
5. Enables scalable auditing even as volumes and complexity in business processes grow.
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