Factbird's Quality & Compliance (CFR Part 11)

WHAT THIS IS

• 21 CFR Part 11 defines the requirements for using electronic records and electronic signatures in FDA-regulated industries. Factbird supports the core principles of the regulation by providing features that help ensure electronic records are trustworthy, traceable, and attributable to the correct individual. 
  
  

• Rather than being a single feature, Quality & Compliance is a collection of capabilities that work together to support compliant digital quality processes
   

• Need a formal document for your quality or validation team? Download the 21 CFR Part 11 Validation Support Package (PDF), also available in our PDF Hub
   

WHY IT MATTERS

Manufacturers operating in regulated industries must be able to demonstrate that electronic records:

• Are attributable to the correct individual.
• Cannot be modified without traceability.
• Maintain a complete audit history.
• Are protected from unauthorized access.
• Remain available during internal and regulatory audits.

• Factbird provides the controls needed to support these requirements while replacing paper-based quality processes with digital workflows.
   

WHEN YOU WOULD USE THIS

• Use this when:
  • You operate in an FDA-regulated industry
  • You want to replace paper-based documentation with digital systems
  • You need to ensure records are legally valid and audit-ready
  • You must prove data integrity and user accountability across operations
     

HOW IT WORKS

Factbird supports the key principles of 21 CFR Part 11 through the following capabilities:

Electronic Signatures

• Activities can require electronic signatures before completion. Signatures are uniquely linked to an individual and require authentication using an operator profile or user account with a PIN, ensuring actions are attributable to the person performing them.
   

Multi-Level Approval

• Critical activities can require both an operator signature and an independent reviewer approval before the record is considered complete, supporting controlled review workflows.
   

Audit Trails

• Factbird automatically records who performed an action, what changed, and when it occurred. Audit trails preserve the complete history of each record and provide the traceability required during audits.
  
  

Controlled Record Corrections

• Completed records are not overwritten. When corrections are required, Factbird preserves the original information while recording the reason for the change and the identity of the person making it.
   

Access Control

• Permissions determine who can perform activities, review activities, approve records, and manage electronic signatures. This helps ensure only authorized users can perform regulated actions.
   

Traceable Records

• Every activity maintains a complete record of signatures, approvals, corrections, and version history, ensuring historical information remains available for review.
  
   

KEY TERMS / COMPONENTS

• Electronic Signature

  A uniquely authenticated confirmation linked to a specific individual and activity record.
   

• Audit Trail

  A time-stamped history showing who performed each action and when it occurred.
   

• Access Control

  Permissions that determine which users can perform regulated actions.
   

• Multi-Level Sign-Off

  A workflow requiring both operator completion and reviewer approval before an activity is finalized.
   

• Traceable Records

• Records that preserve their complete history, including signatures, approvals, and corrections.
   

COMMON MISUNDERSTANDINGS

• Factbird does not become "21 CFR Part 11 compliant" on its own. Compliance depends on both the platform capabilities and how your organization configures and uses them.
   

• Electronic signatures are only one part of 21 CFR Part 11. Audit trails, access control, traceable records, and controlled corrections are equally important.  
  
  
   

  
  
   

Related Articles

• Hub: 21 CFR Part 11