FDA 21 CFR Part 11
Electronic records and electronic signatures
COMPLIANCE & SECURITY
Protect the records.
Make the evidence reviewable.
Inspection readiness depends on trustworthy records and clear evidence. Allyfe brings privacy, security and traceable review into the workflows clinical teams use every day.
Explore our approach ↓OUR APPROACH
Security by design.
Experts in control.
Protect access to study information. Keep evidence connected to its sources. Give reviewers the context to make and explain their decisions.
Discuss the current controls and supporting documentation for your intended use with our team.
REGULATORY & SECURITY REFERENCES
The frameworks behind the requirements.
GDPR
Personal data protection
ICH GCP
Good Clinical Practice
PRIVACY & DATA PROTECTION
Protection starts with the design.
Allyfe’s approach incorporates data minimisation, user authentication, access control and encryption. Pseudonymisation and anonymisation are part of the privacy measures described in the original platform design.
The appropriate controls, data flows and responsibilities should be reviewed for each deployment and intended use.
Read our Privacy Policy →SECURITY FOUNDATIONS
Control access. Separate data.
Protect the infrastructure.
Access at study level
The platform design separates study data logically and limits access on a study-by-study basis. Deployment requirements include data location, tenant separation and authorised access.
Encryption and recovery
The original security design describes encryption in transit and at rest, alongside encrypted backups and disaster-recovery arrangements. Review the current configuration and recovery requirements with Allyfe.
Layered safeguards
Network segmentation, firewalls, application protections, vulnerability scanning and security monitoring form part of the approach described for the platform.
TRANSPARENT EVIDENCE REVIEW
Follow the finding.
Keep the decision with your experts.
CEE connects findings to supporting documents. Reviewers can inspect the evidence and accept, change or reject an assessment. Rules handle defined comparisons; AI supports tasks that need interpretation.
The scope of a review depends on the checks agreed and the documents available. A finding supports investigation; it does not certify a study or guarantee an inspection outcome.
Explore the Compliance Evidence Engine →BEFORE DEPLOYMENT
Review the controls for your intended use.
Discuss your study workflow, data handling requirements and review responsibilities with Allyfe. Agree the scope of the deployment and the evidence your organisation needs for its own assessment.
Privacy and security review
Discuss data location, access permissions, encryption, backup arrangements and the documentation available to support your assessment.
Quality and compliance review
Agree intended use, review coverage, validation responsibilities and the role of your clinical and quality experts before relying on outputs in your workflow.
LET’S TALK ABOUT YOUR REQUIREMENTS
See the workflow. Ask the questions.
Book a short walkthrough and discuss the privacy, security and evidence-review requirements for your study.
Book a demo ↗