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Technology expertise

Regulatory compliance

We integrate regulatory and industry-specific compliance standards into the software lifecycle, ensuring systems meet legal, security, and audit requirements from day one.

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Expertise

Compliance-ready from day one

At Enliven Systems, we build regulatory and industry-specific compliance into your software from the ground up, ensuring global legal, security, and audit standards are met across markets, from development through deployment.

Global standards. Built-in compliance.

At Enliven Systems, regulatory compliance is foundational, not optional. We architect software with compliance implemented on every layer of the development lifecycle, helping your systems meet legal, security, and audit requirements across borders and industries.

Whether deploying SaaS products, building financial applications, or managing sensitive user data, we ensure your systems comply with the regulatory frameworks that matter most to your business.

Key regulatory standards we support

Based in Hungary and operating internationally, we support compliance across jurisdictions and industries, focusing on scalable, secure, and transparent solutions.

GDPR (General Data Protection Regulation)

Required for any organization handling personal data of EU citizens. We implement privacy-by-design, data minimization, consent management, and cross-border data handling practices that align with GDPR obligations.

ISO 27001

The international gold standard for information security management systems (ISMS). We can align your product and internal practices with ISO 27001 requirements for enterprise trust and market expansion.

NIS 2 Directive (EU Directive on Network and Information Security)

A key update to the EU’s cybersecurity framework, NIS 2 imposes stricter obligations on essential entities across sectors. We help integrate incident response, risk management, and supply chain security practices to meet NIS 2 requirements and avoid penalties.

DORA (Digital Operational Resilience Act)

DORA targets financial entities operating in the EU and focuses on ensuring operational resilience in the face of cyber threats. Our approach supports ICT risk management, incident reporting, and third-party risk controls aligned with DORA mandates.

ISO 9001 (Quality Management Systems)

ISO 9001 (Quality Management Systems) To ensure consistent quality and customer satisfaction, we build systems and internal practices that support ISO 9001 certification, including continuous improvement, documentation, and quality assurance mechanisms.

ISO 14001 (Environmental Management Systems)

ISO 14001 (Environmental Management Systems) For clients prioritizing sustainability, we help align digital operations with ISO 14001 standards — integrating environmentally conscious practices into project planning, lifecycle management, and cloud infrastructure choices.

HIPAA (Health Insurance Portability and Accountability Act)

Essential for healthcare software used in the U.S., we design systems with safeguards for electronic Protected Health Information (ePHI), supporting confidentiality, access controls, audit trails, and breach notification compliance.

TISAX (Trusted Information Security Assessment Exchange)

Tailored for the automotive sector and its suppliers, TISAX ensures strict compliance with information security, data protection, and prototype handling. We support the implementation of controls based on the VDA ISA framework, helping you achieve TISAX labels efficiently.

PCI DSS (Payment Card Industry Data Security Standard)

PCI DSS (Payment Card Industry Data Security Standard) Critical for any credit card transaction system. Our solutions enforce secure payment flows, encryption, tokenization, and vulnerability management to meet PCI DSS controls.

SOC 2 (System and Organization Controls)

A trusted compliance standard for service organizations, especially SaaS providers. We help implement controls across Security, Availability, Processing Integrity, Confidentiality, and Privacy (the SOC 2 Trust Service Criteria), and support the creation of evidence for third-party audits.

What does our approach include?

60% of firms cite budget/talent shortages as barriers to compliance. See how we help.

KPI-driven

We proactively monitor Risk Severity Distribution (categorizing risks as low, medium, or high) and third-party compliance scores to assess vendor adherence. For software teams, Defect Density (bugs per code unit) and Escaped Defects (issues reaching production) are critical quality indicators that indirectly reflect compliance maturity.

Regulatory Compliance Rate

Percentage of systems/components meeting all applicable standards (e.g., GDPR, HIPAA, PCI DSS).

Our target: ≥95% compliance rate

0%

Audit Success Rate

Percentage of audits passing without major non-conformities.

Our target: 95% success rate.

0%

Mean Time to Resolution (MTTR)

Average time to resolve compliance issues from detection.

< 24 h

Our target: critical issues resolved within 24–72 hours.

Risk Severity Distribution

Percentage of risks categorized as low, medium, or high impact.

Our target: <5% high-severity risks.

0%

Defect Density

Number of compliance-related code defects per 1,000 lines.

Our target: <0.25 critical defect/KLOC.

< 0

Vendor Compliance Score

Percentage of third-party vendors meeting contractual compliance obligations.

Our target: 100% for critical vendors.

0%

Software Bill of Materials (SBOM) Completeness

Percentage of open-source/components with validated licenses and vulnerabilities.

Our target: 100% SBOM coverage.

0%

Stay in control with actionable compliance metrics.

We help you track defect density, vendor risk, audit success, and more — all mapped to industry standards. Our KPI-driven approach ensures that you not only meet expectations, but exceed them.

Explore KPI Solutions

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Compliance isn’t bolted on – it’s built-in from the start. Shifting left in software development refers to integrating security and compliance considerations as early as possible in the development lifecycle. This includes:

Integrating regulatory logic and controls such as role-based access control, audit logging, data encryption, and user consent mechanisms into the development process.

Automating compliance checks within CI/CD pipelines, enabling real-time policy enforcement and defect detection before code reaches production.

Embedding compliance validation into pull requests and automated testing, reducing manual review efforts by 30–50%.

This embedded approach ensures compliance is continuous, automated, and aligned with development velocity, preventing costly remediation later.

See how we manage Security on the software stack level

Industry-aligned practices

The average enterprise must comply with 50+ regulations, creating significant operational overhead. Software agencies face particular challenges in third-party risk management, where 40% of breaches originate from vendor vulnerabilities. Our clients increasingly demand proof of supply chain security, requiring documented assessments of subcontractors and open-source components.

Our team understands the nuances of compliance across various industries, including healthcare, fintech, and enterprise SaaS. We adopt development methodologies and architectural decisions to meet regulatory and sector-specific expectations.

Tailoring compliance strategies

To industry-specific standards across healthcare, fintech, SaaS, and more.

Conducting documented assessments of subcontractors and open-source components

To ensure supply chain security.

Implementing vendor compliance monitoring

To achieve 100% adherence among critical suppliers, reducing operational overhead and breach risks.

Automated documentation & monitoring

Over 60% of organizations cite limited budgets and cybersecurity talent shortages as barriers to compliance. Automated tools such as GRC platforms and CI/CD-integrated scanners help mitigate these gaps by streamlining audits and policy enforcement.

We implement automated testing, CI/CD pipeline checks, and system logging that generate the documentation and visibility needed for internal governance and external audits. For example, embedding compliance checks into pull requests reduces manual review efforts by 30–50%.

See how we tackle challenges for monitoring key applications, data, and business performance data.

Deploying Governance, Risk, and Compliance (GRC) platforms integrated with CI/CD pipelines for continuous compliance monitoring.

40%

Automating audit documentation and evidence gathering, which cuts audit preparation time by over 40%.

Using system logging and compliance dashboards to provide real-time visibility into compliance status for internal governance and external audits.

AI-driven compliance automation

Machine learning models can now predict audit failures with 85% accuracy by analyzing historical compliance data, enabling preemptive corrections. This translates to reduced non-compliance costs and faster certification cycles for our clients.

Automated risk scoring and prioritization

AI continuously assesses compliance risks across your software environment, prioritizing high-impact issues for immediate resolution. This ensures resources focus on the most critical vulnerabilities.

Integration with CI/CD pipelines

Compliance checks powered by AI are embedded directly into your development workflows, automatically flagging compliance defects during code commits and pull requests, thereby minimizing escaped defects and improving overall software quality.

Continuous learning and adaptation

Our AI models evolve with your environment, incorporating new regulatory updates and audit outcomes to refine predictions and maintain compliance effectiveness over time.

Strategic implementation of compliance practices

Successful programs require cross-functional collaboration. Tone-from-the-top messaging, exemplified by executive video endorsements on compliance pages, increases employee policy adherence by 35%. Gamified training modules and quarterly compliance hackathons further reinforce engagement, boosting certification pass rates by 20%.

Compliance hackathons and workshops

Quarterly events encourage cross-functional teams to identify compliance challenges and develop innovative solutions, fostering a culture where compliance is a shared responsibility.

Clear communication channels

We establish dedicated compliance portals and feedback loops, ensuring employees can easily access policies, report concerns, and receive timely guidance.

Continuous improvement framework

Through regular audits, feedback, and performance reviews, we help embed compliance into everyday workflows, driving sustained adherence and operational excellence.

International standards readiness

With clients and operations across multiple jurisdictions, we help you align with evolving global standards - GDPR in the EU, HIPAA in the U.S., or cross-border data transfer frameworks such as SCCs or the EU-U.S. Data Privacy Framework.

Regulatory change monitoring

We maintain automated monitoring of global regulatory bodies and promptly update your compliance frameworks to reflect new or amended standards, including the GDPR, HIPAA, SCCs, and the EU-U.S. Data Privacy Framework.

Impact analysis and gap assessment

When regulations change, we conduct detailed impact assessments to identify affected systems, processes, and controls, prioritizing remediation efforts accordingly.

Policy and process updates

We revise internal policies, consent mechanisms, data handling procedures, and security controls to ensure complete alignment with international requirements.

Cross-border data transfer compliance

We implement technical and contractual safeguards, such as Standard Contractual Clauses (SCCs), to enable lawful data flows between jurisdictions.

Documentation and audit support

Comprehensive records of compliance activities and regulatory changes are maintained to support audits and demonstrate due diligence.

Training on regional requirements

We provide targeted training to ensure teams understand jurisdiction-specific obligations and best practices.

Benefits of compliance integration with Enliven Systems

Risk mitigation

Proactively address legal and security risks before deployment.

Operational efficiency

Streamline development with integrated compliance processes.

Audit readiness

Maintain thorough documentation and reporting for seamless audits.

Competitive advantage

Demonstrate commitment to industry best practices and regulatory adherence.

Customer trust

Build confidence through robust security and privacy protections.

FAQs

Compliance is embedded from the earliest stages — from architecture design through development, testing, deployment, and maintenance. We apply secure coding practices, role-based access controls, encryption, automated auditing, and continuous monitoring, all aligned with your specific regulatory requirements.

We have deep experience in healthcare, finance, enterprise SaaS, automotive supply chains, and e-commerce. Each vertical has its compliance nuances, and our cross-sector experience helps ensure best practices are applied holistically.

The timeline varies based on the complexity of your systems and the specific regulatory framework. For most clients, an initial compliance assessment and roadmap can be delivered within two to four weeks. Implementation for common standards (e.g., GDPR, ISO 27001) typically ranges from 2 to 6 months, depending on your starting point, system size, and resource availability. We provide a detailed project plan after our initial assessment.

We offer ongoing support packages tailored to your needs. This can include continuous monitoring, regulatory update alerts, periodic compliance reviews, support during audits, and rapid response to new regulatory changes. Our managed compliance services ensure you stay compliant as your business and regulations evolve.

Ready to simplify audits and strengthen trust?

Let us help you embed compliance into every layer of your software lifecycle—so you can reduce audit stress, meet global standards, and build lasting confidence with customers and regulators alike.