Fraud Alert

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.

Request Compliance Consultation zigzag-border

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

underline

Built with the Tech That Powers the World

Microsoft

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

underline

Requirements

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

Test planning

icon
  • Sprint Planning
  • Resourcing
  • Story Traceability
  • Test Environments

Test Prep

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

Test execution

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

Go live & support

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

Key Benefits

underline
Key benefits visual
benefit-icon

Secure PHI and ensure patient privacy

benefit-icon

Meet international healthcare regulatory standards

benefit-icon

Reduce risk of fines, legal exposure, and reputational harm

benefit-icon

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

underline
update
Unencrypted PHI in transit

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

rule_folder
Incomplete audit logs

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

cloud_sync
cloud_done
Electronic record non-compliance

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

public
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
ZigZag Border Insight Dots Group

We are excited to hear your idea and we are always open to discuss it! Tell us a bit more about you and the project you have in mind.

Book Your Free Strategy Call

line-svg

Vervali in a brief:

line-svg

15+

years of

Industry Experience

250+

Experts

Onboard

ISTQB-

Certified

Test Engineers

Upwork ISTQB Certification 1 Certification 2

Contact Us

line-svg
phone

India – Mumbai

+91 7219-22-5262
vervali-logo

EoR

Quality Assurance

Development

Cloud

Devops

Market Research

EoR

Quality Assurance

Development

Cloud

Devops

Market Research

EoR

Quality Assurance

Development

Cloud

Devops

Market Research

EoR

Quality Assurance

Development

Cloud

Devops

Market Research

EoR

Quality Assurance

Development

Cloud

Devops

Market Research

EoR

Quality Assurance

Development

Cloud

Devops

Market Research

EoR

Quality Assurance

Development

Cloud

Devops

Market Research

EoR

Quality Assurance

Development

Cloud

Devops

Market Research

EoR

Quality Assurance

Development

Cloud

Devops

Market Research

EoR

Quality Assurance

Development

Cloud

Devops

Market Research

EoR

Quality Assurance

Development

Cloud

Devops

Market Research