Compliance standard

FDA 21 CFR Part 11 templates

Policies, SOPs, plans, job aids, spreadsheets and decks aligned to FDA 21 CFR Part 11, tailored to your organization in minutes.

Each FDA 21 CFR Part 11 template is generated by AI around the requirements and controls FDA 21 CFR Part 11 expects you to document. You pick a document type, add your company details, and get a structured draft with purpose, scope, roles, procedures and review steps.

Use these documents to close gaps before an audit, show evidence to customers, or give staff clear instructions. Export to Word, Markdown or CSV and edit freely.

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Policy

Information Security Policy (FDA 21 CFR Part 11)Acceptable Use Policy (FDA 21 CFR Part 11)Access Control Policy (FDA 21 CFR Part 11)Data Retention Policy (FDA 21 CFR Part 11)Data Classification Policy (FDA 21 CFR Part 11)Password Policy (FDA 21 CFR Part 11)Remote Work Policy (FDA 21 CFR Part 11)Vendor Management Policy (FDA 21 CFR Part 11)Change Management Policy (FDA 21 CFR Part 11)Encryption Policy (FDA 21 CFR Part 11)Privacy Policy (FDA 21 CFR Part 11)Code of Conduct (FDA 21 CFR Part 11)

Plan

Incident Response Plan (FDA 21 CFR Part 11)Business Continuity Plan (FDA 21 CFR Part 11)Disaster Recovery Plan (FDA 21 CFR Part 11)Risk Management Plan (FDA 21 CFR Part 11)System Security Plan (FDA 21 CFR Part 11)Plan of Action & Milestones (FDA 21 CFR Part 11)

SOP

Employee Onboarding SOP (FDA 21 CFR Part 11)Employee Offboarding SOP (FDA 21 CFR Part 11)Backup & Restore SOP (FDA 21 CFR Part 11)Patch Management SOP (FDA 21 CFR Part 11)User Access Review SOP (FDA 21 CFR Part 11)Customer Complaint Handling SOP (FDA 21 CFR Part 11)Document Control SOP (FDA 21 CFR Part 11)Quality Inspection SOP (FDA 21 CFR Part 11)Log Review Procedure (FDA 21 CFR Part 11)Vulnerability Scanning Procedure (FDA 21 CFR Part 11)

Job Aid

Password Reset Job Aid (FDA 21 CFR Part 11)Phishing Recognition Job Aid (FDA 21 CFR Part 11)Incident Reporting Quick Card (FDA 21 CFR Part 11)New Hire Checklist (FDA 21 CFR Part 11)Visitor Sign-In Quick Reference (FDA 21 CFR Part 11)Clean Desk Quick Card (FDA 21 CFR Part 11)

Spreadsheet

Risk Register (FDA 21 CFR Part 11)Asset Inventory (FDA 21 CFR Part 11)Control Matrix (FDA 21 CFR Part 11)Vendor Risk Assessment Questionnaire (FDA 21 CFR Part 11)Gap Analysis Workbook (FDA 21 CFR Part 11)Training Tracker (FDA 21 CFR Part 11)Evidence Collection Tracker (FDA 21 CFR Part 11)

Presentation

Security Awareness Training Deck (FDA 21 CFR Part 11)Board Compliance Briefing (FDA 21 CFR Part 11)Audit Readiness Kickoff Deck (FDA 21 CFR Part 11)New Policy Rollout Deck (FDA 21 CFR Part 11)Quarterly Risk Review Deck (FDA 21 CFR Part 11)

Report

Audit Report Template (FDA 21 CFR Part 11)Internal Audit Checklist (FDA 21 CFR Part 11)Management Assertion Letter (FDA 21 CFR Part 11)Post-Incident Review Report (FDA 21 CFR Part 11)