FDA Compliant Electronic Records

Full 21 CFR Part 11 compliance built into every feature. Audit-ready documentation included.

What is 21 CFR Part 11?

21 CFR Part 11 is FDA guidance that establishes when electronic records and signatures are equivalent to handwritten ones and considered trustworthy, reliable, and generally equivalent to any handwritten records or handwritten signatures executed on paper.

Why It Matters

Pharmaceutical companies must maintain secure, verifiable records for regulatory inspection by the FDA. 21 CFR Part 11 compliance is mandatory for any company handling:

  • Manufacturing protocols
  • Quality control records
  • Batch records
  • Validation documentation
  • Audit documentation
  • Training records

SwiftDocs Approach

We've built compliance into the core architecture rather than bolting it on afterward. Every feature—from document versioning to e-signatures—is designed with 21 CFR Part 11 requirements in mind.

This means your team can focus on their work while SwiftDocs handles compliance automatically.

Built-In Compliance Features

Every SwiftDocs feature is designed to meet or exceed 21 CFR Part 11 requirements.

Electronic Signatures (11.100)

FDA-validated e-signatures with full intent-to-sign verification. Each signature is cryptographically bound to the document and signer identity.

Data Integrity (11.10)

Ensure accuracy, completeness, and authenticity of electronic records through HMAC and cryptographic verification.

Audit Trails (11.10)

Immutable, comprehensive audit trails tracking all system activity. Timestamps, user identity, and actions permanently recorded.

System Validation

Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation available for regulatory submissions.

Access Control (11.100)

Role-based access control ensures only authorized personnel can view, edit, or sign documents. Multi-factor authentication required.

Backup & Archive

Automatic backup and long-term archival of all electronic records. Restore capability for document inspection and regulatory review.

21 CFR Part 11 Requirements

Here's how SwiftDocs addresses each key requirement of 21 CFR Part 11.

Section 11.10(a): Accuracy, Completeness, Security, and Confidentiality

SwiftDocs maintains strict controls to ensure electronic records are accurate, complete, secure, and confidential throughout their lifecycle.

Implemented

Section 11.10(b): Identification of Persons

All system activity is identified by unique user IDs. User identification is captured and maintained in audit trails.

Implemented

Section 11.10(c): Document/Record Discrepancies

Investigation procedures for discrepancies are logged. Changes are tracked with user identification and timestamps.

Implemented

Section 11.10(e): Automatic Logoff

System implements automatic session termination after configurable inactivity periods. Re-authentication required for resumption.

Implemented

Section 11.100: Electronic Signatures

E-signatures satisfy all legal requirements equivalent to handwritten signatures. Each signature includes date, time, and intent verification.

Implemented

Section 11.70: Meaning of "Electronically Signed"

Signers attest they have reviewed records and agree with their contents. Signature status is visibly displayed on documents.

Implemented

Section 11.100(b): Signature/Initial Codes and Passwords

Signers establish unique codes and passwords. Only authorized signers can apply their electronic signatures. Biometric authentication supported.

Implemented

Section 11.200: Copying or Transferring of Records

Electronic records can be copied or transferred while maintaining integrity and audit trail associations.

Implemented

Electronic Signatures

E-signatures in SwiftDocs are legally equivalent to handwritten signatures under 21 CFR Part 11.

How E-Signatures Work

  1. Signatory reviews document in detail
  2. Signatory enters signature code and password
  3. Intent-to-sign confirmation required
  4. Signature applied with date, time, and user ID
  5. Document locked and becomes immutable
  6. Audit trail created automatically

Signature Attributes

Each electronic signature in SwiftDocs includes:

  • Printed name of signatory
  • Date and time of signature
  • Meaning of signature (executed by, reviewed by, approved by)
  • Cryptographic hash verification
  • Biometric authentication option

Comprehensive Audit Trails

SwiftDocs maintains detailed, immutable audit trails for every action on every document.

Tracked Events

  • Document creation
  • Version changes
  • Document access
  • Editing and modifications
  • Review actions
  • Electronic signatures
  • Approval workflow steps
  • Deletion and archival

Audit Trail Details

Each audit trail entry includes:

  • Date and time (system-generated)
  • User identification
  • Action performed
  • Document version affected
  • Reason for action (if applicable)
  • System-generated checksum
  • Immutable storage

Regulatory Submission Support

We provide comprehensive documentation to support your FDA submissions and inspections.

Documentation Provided

  • System IQ/OQ/PQ Documentation
  • Security & Control Assessment
  • Audit Trail Sample Reports
  • E-Signature Validation Data
  • Data Integrity Verification
  • Disaster Recovery Procedures

Ready for FDA Inspection

SwiftDocs generates FDA inspection reports on demand. Export complete documentation for:

  • NDA/ANDA submissions
  • Preapproval inspections
  • Routine compliance inspections
  • Process validation audits

HR Compliance & Employee Credentials

FDA inspectors expect to see documented evidence of employee competency, training, and qualifications. SwiftDocs makes HR compliance simple.

Employee Credential Management

Maintain centralized records of:

  • Resumes and CVs with version control
  • Professional licenses and certifications
  • Training completion records
  • Qualification documentation
  • Background check records
  • Competency assessments

FDA Inspection Ready

Generate compliance-ready reports showing:

  • Employee competency for each role
  • Training completion dates and status
  • Certification validity periods
  • Complete audit trails of all changes
  • Signed approval records
  • Historical documentation for inspections

Compliance & Security Working Together

21 CFR Part 11 compliance relies on security as its foundation. Learn how our security practices ensure your compliance requirements are met.

Ready to Get Started?

SwiftDocs makes 21 CFR Part 11 compliance effortless. See how your team can focus on science while we handle compliance.