21 CFR Part 11
Trusted Records. Trusted Decisions.
Protect electronic records with secure access, complete audit trails, validated workflows, and compliant electronic signatures built for regulated environments.
Faster Audit Prep
Faster CAPA Closure
Audit-Ready Uptime
Less Manual Effort
Record Traceability
ISO 9001 Aligned
What is FDA 21 CFR Part 11
21 CFR Part 11 establishes the FDA requirements for electronic records and electronic signatures. It defines how regulated organizations create, store, protect, and maintain trustworthy digital records while preserving their authenticity, integrity, and confidentiality throughout the record lifecycle.
A compliant electronic quality system provides documented evidence, secure user access, audit trails, electronic signatures, and validated processes that withstand regulatory review.
Benefits of 21 CFR Part 11
Electronic records carry the same regulatory weight as paper records. Qualityze helps organizations maintain trusted records, controlled access, and complete accountability across every quality process.
TALK TO A QUALITY EXPERTElectronic Records
Capture, store, retrieve, and preserve regulated records through controlled processes that support authenticity throughout the record lifecycle.
Electronic Signatures
Associate every approval with verified user credentials, creating accountable electronic signatures that satisfy regulatory expectations.
Audit Trails
Record every creation, update, approval, and revision automatically, providing a complete history of every regulated record.
Data Integrity
Protect regulated information through controlled access, revision history, user authentication, and permanent record retention.
System Validation
Operate within validated processes supported by documented testing, controlled configuration, and ongoing change management.
Secure Access
Assign role-based permissions that protect sensitive information while giving authorized users appropriate access across quality operations.
Which Qualityze Solutions Support the Requirements of 21 CFR Part 11?
21 CFR Part 11 establishes the controls required for electronic records and electronic signatures. Qualityze provides the capabilities needed to protect data integrity, maintain secure records, and document every regulated activity.
Create, store, retain, and retrieve regulated records through controlled processes that preserve record authenticity throughout the lifecycle.
- Document Management
- Batch Records Management
Five Steps to 21 CFR Part 11 Compliance
Build trust in every electronic record with controlled processes that satisfy FDA expectations for security, integrity, and accountability.
Step 1
Create Electronic Records
Record quality activities through controlled electronic forms designed to preserve complete, accurate, and attributable information.
- Electronic Records
- Controlled Forms
- Data Capture
From Paper Records to Trusted Electronic Records
BEFORE QUALITYZE
Electronic Records Without Control
- Electronic records exist across disconnected systems and shared drives.
- Manual signatures create delays and inconsistent approval records.
- Audit history is incomplete or difficult to reconstruct.
- User access is difficult to control across quality processes.
- Data integrity depends on manual checks and documentation practices.
AFTER QUALITYZE
Electronic Records You Can Trust
- Electronic records remain protected through controlled access and version history.
- Electronic signatures capture verified approvals with complete accountability.
- Audit trails document every record creation, revision, and approval automatically.
- Role-based permissions keep regulated information accessible to authorized users.
- Validated workflows strengthen data integrity throughout the record lifecycle.
Ready for Every FDA Inspection?
See how Qualityze helps regulated organizations maintain trusted electronic records, compliant electronic signatures, and complete audit trails through one connected Quality Management System.