Compliance Services (HIPAA, 21 CFR Part 11)

Specialized compliance solutions for healthcare and pharmaceutical industries. Ensure regulatory compliance with HIPAA, 21 CFR Part 11, and other industry standards.

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Who This Is For

Healthcare Providers

Hospitals, clinics, and medical practices that need HIPAA compliance for patient data protection.

Pharmaceutical Companies

Drug manufacturers requiring 21 CFR Part 11 compliance for electronic records and signatures.

Medical Device Companies

Device manufacturers needing FDA compliance and quality management system validation.

Compliance Challenges We Solve

Regulatory Fines and Penalties

Non-compliance with HIPAA, FDA, or other regulations leading to costly fines and legal issues.

Data Breach Risks

Inadequate protection of sensitive patient or research data, exposing organizations to security breaches.

Failed Audits

Inability to demonstrate compliance during regulatory audits, resulting in operational disruptions.

Compliance Success Record

100%
Audit Success Rate
Clients passing regulatory audits
Zero
Data Breaches
Post-implementation security record
90%
Faster Compliance
Reduction in compliance preparation time
$500K
Avoided Penalties
Average regulatory fines prevented

Compliance Standards We Support

HIPAA Compliance

  • Privacy Rule implementation
  • Security Rule compliance
  • Breach notification procedures
  • Business Associate Agreements
  • Risk assessments

21 CFR Part 11

  • Electronic signature validation
  • Electronic records management
  • Audit trail implementation
  • System validation
  • Data integrity controls

Ensure Your Compliance Today

Don't risk regulatory penalties. Get a comprehensive compliance assessment and protect your organization.

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