21 CFR Part 11 Assessment

Comprehensive compliance assessment for electronic records and signatures in regulated environments.

Key Capabilities

100%
Regulatory compliance
Zero
FDA 483 observations
50%
Faster validation cycles
Audit-ready
Documentation

What We Do

1. Commercial AI
1. Commercial AI
1. Commercial AI
Problem Addressed
Electronic systems in life sciences must comply with FDA regulations. Organizations need expert assessment with remediation to prove GxP compliance.
Where It Fits
Compliance layer ensuring all systems meet regulatory requirements for electronic records.

Key Capabilities

1. Commercial AI
1. Commercial AI
1. Commercial AI
Gap Assessment
Comprehensive evaluation against 21 CFR Part 11 requirements.
Remediation Planning
Prioritized roadmap addressing compliance gaps.
System Validation
Computer system validation including IQ, OQ, PQ.
Policy Development
SOPs and policies for electronic records management.
Training Programs
User training on compliant system use and documentation.
Audit Support
Preparation and support for regulatory inspections.

How Clients Engage

1. Commercial AI
1. Commercial AI
1. Commercial AI
Assess
Evaluate current state and identify opportunities
1
Design
Architect solutions tailored to your needs
2
Implement
Execute with proven methodologies and best practices
3
Scale
Optimize and expand for enterprise-wide impact
4

Our Solutions

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