United States Pharmaceutical

FDA 21 CFR Part 11 Compliance

FDA 21 CFR Part 11 establishes the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures. ATEK's environmental monitoring platform is designed from the ground up to help organizations achieve and maintain compliance with these critical regulations.

Authority: U.S. Food and Drug Administration (FDA)

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Why Choose ATEK for 21 CFR Part 11 Compliance

Reduce Compliance Risk

Built-in controls and automated documentation help minimize the risk of FDA citations and warning letters.

Streamline Audits

Comprehensive audit trails and exportable reports make FDA inspections smoother and more efficient.

Protect Data Integrity

Immutable records and secure storage ensure your critical monitoring data remains accurate and unaltered.

Save Time & Resources

Automated compliance features reduce manual documentation burden and free up staff for higher-value activities.

21 CFR Part 11 Requirements

Key compliance requirements and how ATEK addresses each one.

Requirement	Description	ATEK Solution
11.10a System Validation	Systems must be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.	IQ/OQ/PQ Documentation ATEK provides comprehensive validation documentation packages including Installation Qualification, Operational Qualification, and Performance Qualification protocols.
11.10b Record Generation	Systems must generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency.	PDF & CSV Export All monitoring data can be exported in multiple formats including PDF reports and CSV files for human-readable and electronic record keeping.
11.10c Record Protection	Records must be protected throughout their retention period to enable accurate and ready retrieval.	Cloud-Based Secure Storage Data is stored in SOC 2 compliant cloud infrastructure with automated backups and redundancy across multiple geographic regions.
11.10d System Access Controls	Access must be limited to authorized individuals.	Role-Based Access Control Granular user permissions with configurable roles ensure only authorized personnel can access specific data and functions.
11.10e Audit Trails	Secure, computer-generated, time-stamped audit trails must independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Audit trail documentation must be retained for at least as long as the subject electronic records and be available for agency review and copying.	Immutable Audit Trails Every data point and system action is logged with timestamp, user ID, and cannot be modified or deleted.
11.10g Authority Checks	Systems must use authority checks to ensure only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.	Multi-Factor Authentication Secure login with optional MFA ensures only authorized users can access the monitoring platform.
11.50 Electronic Signatures	Signed electronic records must contain the printed name of the signer, the date and time when the signature was executed, and the meaning (such as review, approval, responsibility, or authorship) associated with the signature.	Electronic Signature Support Built-in electronic signature functionality with full audit trail of signer identity, timestamp, and signature meaning.
11.100 Signature Uniqueness	Each electronic signature must be unique to one individual and not reused or reassigned.	Unique User Credentials Each user has unique login credentials that cannot be shared or transferred between individuals.

Understanding 21 CFR Part 11

FDA 21 CFR Part 11 was established in 1997 to provide criteria for acceptance of electronic records and electronic signatures. The regulation applies to all FDA-regulated industries where electronic records are used to meet FDA requirements.

Scope of the Regulation

The regulation applies to records that are:

Created, modified, maintained, archived, retrieved, or transmitted in electronic form
Required by FDA predicate rules
Submitted electronically to the FDA

Key Technical Requirements

Closed System Controls (11.10): Organizations using closed systems must employ procedures and controls including validation, audit trails, system access limitations, and device checks.

Open System Controls (11.30): Additional controls are required for open systems, including encryption and digital signatures.

Electronic Signatures (Subpart C): Electronic signatures must be unique to one individual, subject to identity verification before assignment, and linked to their respective electronic records so that signatures cannot be excised, copied, or otherwise transferred to falsify a record.

How ATEK Supports Compliance

ATEK’s environmental monitoring platform is purpose-built for regulated industries. Our system provides the technical controls required by 21 CFR Part 11 while maintaining ease of use for your team.

Validation Support

We provide comprehensive validation documentation to support your qualification activities:

Installation Qualification (IQ) protocols
Operational Qualification (OQ) protocols
Performance Qualification (PQ) templates
Validation summary reports

Continuous Compliance

Unlike point-in-time compliance solutions, ATEK provides continuous compliance through:

Real-time monitoring with automated alerts
Immutable audit trails for all system activities
Regular platform updates that maintain compliance
Ongoing validation support with each release

21 CFR Part 11 FAQs

What is FDA 21 CFR Part 11?

FDA 21 CFR Part 11 is a regulation that defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures. It applies to any records required by FDA predicate rules that are created, modified, maintained, archived, retrieved, or transmitted electronically.

Does ATEK's platform meet 21 CFR Part 11 requirements?

Yes, ATEK's environmental monitoring platform includes all the technical controls required for 21 CFR Part 11 compliance, including audit trails, electronic signatures, access controls, and system validation documentation. However, compliance also depends on your organization's procedural controls and how the system is implemented.

What validation documentation does ATEK provide?

ATEK provides comprehensive validation packages including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and templates. These documents are designed to support your validation activities and can be customized to meet your specific requirements.

How does ATEK handle electronic signatures?

ATEK's platform supports electronic signatures that comply with 21 CFR Part 11 requirements. Each signature captures the printed name of the signer, the date and time of signing, and the meaning of the signature (such as review, approval, responsibility, or authorship). All signature events are recorded in the immutable audit trail.

Can I export data for FDA inspections?

Yes, ATEK allows you to export monitoring data, audit trails, and compliance reports in multiple formats including PDF and CSV. These exports include all required metadata and can be provided to FDA inspectors upon request.

Need Help with 21 CFR Part 11 Compliance?

Our team of compliance experts can help you implement monitoring solutions that meet 21 CFR Part 11 requirements. Contact us for a consultation or demo.

Customized compliance assessment for your facility

Validation documentation packages (IQ/OQ/PQ)

Expert support for audits and inspections

Speak with a Compliance Expert

Our team is available to discuss your specific 21 CFR Part 11 compliance requirements.

compliance@atek.io

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Related Regulations

International

GAMP 5

GAMP 5 provides a risk-based framework for validating computerized systems in pharmaceutical and related industries. ATEK's environmental monitoring platform is designed with GAMP 5 principles, providing the validation documentation needed for GxP environments.

Canada

GUI-0050 Annex 11

Health Canada's GUI-0050 Annex 11 provides detailed guidance on the application of Good Manufacturing Practices (GMP) to computerized systems used in pharmaceutical, radiopharmaceutical, biological, and veterinary manufacturing. This guidance was adopted from PIC/S PE-009-15 Annex 11: Computerised Systems, ensuring that Canadian manufacturers meet internationally recognized standards for data integrity, security, and system validation. ATEK's environmental monitoring platform is designed to help organizations achieve and maintain compliance with these comprehensive requirements.

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