FDA 21 CFR Part 11
FDA regulations on electronic records and signatures in pharmaceutical and medical device industries.
Quick Facts
- Documents Included
- 41
- Category
- Healthcare & Life Sciences
- Regions
- United States
- Compliance Domains
- 5 domains
What's Included
SeedGovernance provides 41 ready-to-use templates for FDA, covering 5 compliance domains. Each document is pre-filled with framework-specific guidance so you can start immediately.
Electronic Records
Policies, processes, and evidence templates
Electronic Signatures
Policies, processes, and evidence templates
Data Integrity
Policies, processes, and evidence templates
Computer System Validation
Policies, processes, and evidence templates
Audit Trails
Policies, processes, and evidence templates
How SeedGovernance Helps with FDA
Beyond templates, our platform guides you through every step of FDA compliance.
Assessment Wizard
Answer guided questions to assess your FDA readiness and identify gaps.
Gap Analysis
Automatically surface what's missing from your FDA compliance programme.
Document Library
41 pre-built templates tailored to FDA requirements.
Operations Modules
Track incidents, changes, risks, and vendors — all mapped to FDA controls.
KPI Dashboard
Monitor your FDA compliance score in real time with automated metrics.
Auditor Access
Share a read-only view of your FDA compliance status with auditors.
Related Frameworks in Healthcare & Life Sciences
Organizations using FDA often also need these frameworks.
HIPAA
37 documents
US federal law protecting sensitive patient health information from being disclosed without consent.
EU MDR
18 documents
EU regulation governing the production and distribution of medical devices in the European market.
MHRA
16 documents
UK Medicines and Healthcare products Regulatory Agency framework for medical devices and pharmaceuticals.
GxP
14 documents
Quality guidelines and regulations for life sciences covering GMP, GLP, GCP, and GDP.
ICH GCP
14 documents
International standard for the design, conduct, and reporting of clinical trials involving human subjects.
ISO 13485
14 documents
Quality management system standard for organizations involved in medical device lifecycle.
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