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Ensure U.S. Healthcare Compliance with HIPAA & FDA Testing

Achieve full HIPAA and FDA compliance for EMRs, medical apps, and device platforms in the U.S. healthcare landscape.

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Critical Compliance Solutions for Modern Healthcare Platforms

PHI Security & Privacy Controls Assessment

We rigorously test your system’s authentication, encryption, logging, and access controls to ensure HIPAA-level protection of personal health data.

FDA 21 CFR Part 11 Validation

Validate electronic record-keeping and signatures per FDA standards—ensuring audit readiness through rigorous functional and trace testing.

HIPAA & FDA Gap Analysis & Remediation

We identify compliance gaps via automated and manual audits, prioritize issues, and support remediation to close compliance risks quickly.

Comply with HIPAA & FDA — Fast

Prevent costly fines and secure user trust through end-to-end healthcare compliance.

Vervali Systems

Versatile Across Industries, Focused on Your Business

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Built with the Tech That Powers the World

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Build Resilient & Compliant Healthcare Workflows

Align product releases with rigorous compliance testing and documentation standards.

Vervali Systems

Our Process: From Idea to Execution with Precision

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Requirements

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  • Requirements Review
  • Q & A
  • User Personas
  • Usage Statistics

Test planning

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  • Sprint Planning
  • Resourcing
  • Story Traceability
  • Test Environments

Test Prep

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  • Sprint Refinement
  • Test Cases Creation
  • RTM
  • Test Data Creation

Test execution

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  • Exploratory Testing
  • Regression Testing
  • Automation, Performance, Security, 508c
  • Cross Browser, Multi Device testing

Go live & support

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  • Prod Sanity
  • Hotfixes
  • User Feedback
  • Review & Retrospective

Key Benefits

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Secure PHI and ensure patient privacy

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Meet international healthcare regulatory standards

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Reduce risk of fines, legal exposure, and reputational harm

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Build audit-ready software with clear documentation

Why Vervali?

Data Security

Protecting digital information from unauthorized access, theft, or corruption.

Targeted Testing

Identifying specific areas of the website or application that are most critical or vulnerable to errors, and focusing testing efforts on those areas.

-30% Reduce Bug Cost

Through effective quality assurance practices, such as implementing automated testing, conducting regular code reviews etc.

Focused on Business goals

Aim to maximizing the website's potential to drive growth, increase revenue, and achieve other key performance indicators (KPIs).

-20% Testing Time

Through prioritizing testing efforts based on risk analysis and streamlining the testing process.

Risk Based testing

Involves identifying and prioritizing potential risks associated with a software application or system, and using this information to guide testing efforts.

Build Trust Through Regulatory Rigor

Release with confidence, knowing HIPAA and FDA compliance is built in, not bolted on.

Vervali Systems

Challenges into Triumphs

Turning problems into opportunities for growth and innovation

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Unencrypted PHI in transit

Secured with end-to-end encryption using TLS 1.2+ and secure transmission protocols

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Incomplete audit logs

Addressed with comprehensive activity tracking and immutable, tamper-proof logs

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Electronic record non-compliance

Ensured with 21 CFR Part 11 functional validation and electronic signature compliance

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No incident response process

Implemented with tested breach detection workflows and structured reporting protocols

Launch Compliant and Secure

Prevent costly compliance failures—validate before deployment.

Vervali Systems

Frequently Asked Questions (FAQs)

HIPAA ensures the confidentiality and security of patient health data (ePHI). It's a legal requirement for healthcare software handling sensitive information and critical for building patient trust.

It governs electronic records and signatures used in medical systems. Compliance ensures your software meets integrity, access, and audit requirements defined by the FDA.

We assess data encryption, access controls, user authentication, audit logs, and breach handling to ensure end-to-end HIPAA safeguards are in place and effective.

Yes. We validate security and compliance for mobile health apps, IoT medical devices, and wearables, ensuring safe data sync, BLE encryption, and privacy protection.

A full HIPAA/FDA validation typically takes 4–6 weeks depending on app complexity, audit scope, and the number of integrations involved.

Yes. We provide a detailed compliance report, gap analysis, and remediation summary—ready to support internal or external audits.

Absolutely. We support audit preparation, documentation, and real-time responses to queries from HIPAA or FDA auditors.

Launch with Full Compliance Confidence

Align product releases with rigorous HIPAA and FDA compliance.

Vervali Systems
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Development Help?

Our Expertise

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  • AI & DevOps Solutions
  • Custom Web & Mobile App Development
  • Manual & Automation Testing
  • Performance & Security Testing
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Trusted by 150+ Leading Brands

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A Strong Team of 275+ QA and Dev Professionals

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Worked across 450+ Successful Projects

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