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Dataveris
ENSK

Secure Software. Compliant by Design.

With offices in Austin, Texas and Bratislava, Slovakia, in the heart of Europe, Dataveris helps organizations in regulated industries assess risk, document compliance, and build, validate, test and maintain software that passes audits: GxP, HIPAA, SOC 2, PCI-DSS, ISO 27001, GDPR, the EU AI Act and more.

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Two continents, one standard

Dataveris combines a U.S. presence with a European base in Slovakia, supporting clients on both sides of the Atlantic with U.S. and EU regulatory requirements, in overlapping time zones.

Dataveris Services

Six practice areas covering the full lifecycle of regulated software.

01

Compliance & Risk Assessments

Dataveris provides independent assessments of software, data processes, IT controls and AI systems against regulatory and governance requirements.

  • Readiness and gap assessments (HIPAA, SOC 2, PCI-DSS, ISO 27001, GDPR)
  • EU regulatory readiness: GDPR, EU AI Act, NIS2 and DORA
  • Security architecture reviews
  • AI governance assessments (EU AI Act, NIST AI RMF, ISO/IEC 42001)
  • Risk assessments and risk-based decision support
  • Prioritized findings report with remediation roadmap
02

Compliance Documentation Consulting

Dataveris provides consulting on setting up and maintaining documentation for regulatory compliance.

  • Policies, procedures and SOPs
  • SDLC and validation policies and procedures
  • Risk registers and control matrices
  • Audit and inspection readiness, audit evidence and audit-ready records
  • CAPA documentation
03

IT Consulting: Software Installation, Maintenance & Repair

Dataveris provides IT consulting services relating to installation, maintenance and repair of computer software.

  • Compliant installation and configuration of software, governance and security tools
  • Installation qualification and post-release verification
  • Change control, patch and release management
  • Maintaining the validated state through change control and periodic review
  • Defect remediation and repair of compliance gaps
  • Root-cause analysis and corrective actions
04

Software Testing & Quality Assurance

Dataveris provides software testing and quality assurance for regulated environments.

  • Risk-based test strategy and planning
  • Functional, integration, regression and user acceptance testing
  • Test automation and CI/CD integration
  • API testing
  • Performance and load testing
  • Security testing aligned with OWASP
  • Traceable, audit-ready test documentation
05

Computer System Validation (CSV/CSA)

Dataveris provides validation of computerized systems in GxP-regulated environments, in line with GAMP 5 and the FDA's Computer Software Assurance approach.

  • Validation strategy and risk assessments
  • Installation, operational and performance qualification (IQ/OQ/PQ)
  • Requirements, traceability matrices and validation reports
  • Transition from CSV to risk-based CSA
06

Custom Software Development

Dataveris designs and builds secure, compliance-focused software.

  • Compliance-focused SaaS applications
  • Enterprise and cloud-native solutions
  • Full SDLC with audit-friendly documentation

Approach

A structured path from first finding to a maintained, audit-ready state.

  1. 1

    Assess

    We map your systems, data and controls against the regulations that apply and rank the risks.

  2. 2

    Document

    We create the policies, procedures and records auditors expect to see.

  3. 3

    Build & Implement

    We engineer and configure the fixes, with security and traceability built in.

  4. 4

    Test & Validate

    We verify every requirement with risk-based testing and documented evidence.

  5. 5

    Maintain

    We keep systems in a validated, compliant state through change control and periodic review.

Industries

Regulated sectors where precision and evidence matter.

  • Life Sciences & Pharma

    GxP, GAMP 5, 21 CFR Part 11, EU Annex 11, CSV/CSA

  • Healthcare

    HIPAA, HITECH

  • Finance & Fintech

    SOC 2, PCI-DSS, DORA

  • eCommerce & SaaS

    GDPR, CCPA

  • Government & Public Sector

    FedRAMP, NIST 800-53, NIS2

  • Aviation & Aerospace

    DO-178C, DO-330, FAA, EASA Part-IS

Contact

Tell us about your system, your regulatory scope and your timeline. We reply within two business days.

United States

Dataveris LLC
5900 Balcones Drive #20540
Austin, TX 78731
United States
(346) 680-1990

Slovakia (European headquarters)

Dataveris s.r.o.
Košická 19650/11
821 09 Bratislava – Ružinov
Slovakia

Email

contact@dataveris.com