Turning Compliance Into a Strategic Advantage
Every day, businesses face unseen risks: regulatory fines, operational disruptions, and reputational damage—all stemming from inefficient compliance processes. But what if you could turn compliance into a strategic advantage?
Global organizations lose millions annually due to compliance gaps—missed deadlines, inconsistent reporting, and overwhelming documentation requirements. For example:
- In 2021, Dutch bank ABN Amro was fined €480 million for failing to identify accounts involved in money laundering, showcasing the severe financial repercussions of poor compliance. (Source: fintech.global)
- In 2024, Boeing faced a $243.6 million fine for breaching a deferred prosecution agreement tied to safety compliance issues, emphasizing the critical need for robust compliance management programs. (Source: int-comp.org)
Legacy systems simply can't keep up with today’s dynamic regulatory environment. That’s where Inflectra’s Compliance Management Platform steps in.
Why Choose Inflectra’s Compliance Management Platform?
We go beyond helping you manage compliance—we help you master it. When Inflectra underwent its own FDA desk audit, a process typically lasting five hours, it was completed in just 90 minutes. How? Thanks to SpiraPlan, our centralized compliance management solution. Instead of scrambling through scattered documents and disconnected systems, every critical record—from regulatory requirements and development activities to customer complaints and validation reports—was accessible in real time within a single integrated environment. The result?
- A flawless audit with zero observations
- Auditors were impressed
- The organization remained fully in control
Key Benefits of Inflectra’s Compliance Management Platform:
- Automates regulatory workflows for efficiency
- Centralizes documentation to eliminate data silos
- Provides real-time visibility for proactive compliance
- Ensures you're always audit-ready with half the effort
Don’t wait for your next audit to reveal the gaps. Take control of your compliance strategy today with Inflectra’s Compliance Management Platform.
Trusted Frameworks for Global Compliance
From safeguarding sensitive data to ensuring product quality and risk management, Inflectra’s solutions simplify compliance with globally recognized standards. But it’s not just about meeting requirements—it’s about exceeding them with efficiency and confidence.
Key Benefits of Inflectra’s Compliance Management Platform:
- Automates regulatory workflows for efficiency
- Centralizes documentation to eliminate data silos
- Provides real-time visibility for proactive compliance
- Ensures you're always audit-ready with half the effort
Don’t wait for your next audit to reveal the gaps. Take control of your compliance strategy today with Inflectra’s Compliance Management Platform.
ISO 9001
QUALITY MANAGEMENT SYSTEMS
ISO 9001 is the global standard for establishing and maintaining Quality Management Systems (QMS). It focuses on improving customer satisfaction, operational efficiency, and product quality across industries.
How The Inflectra Platform Supports ISO 9001 Compliance
- Full QMS Implementation: Provides tools for documenting, customizing, and enhancing business processes, ensuring alignment with ISO 9001 requirements.
- Audit and Compliance Monitoring: Supports internal audits, process adherence monitoring, and certification preparation.
- Risk Management: Centralizes incident tracking and corrective actions to maintain consistent quality improvement.
- Defect Reduction: Automates testing and tracking to identify and correct issues early.
- Scalable Compliance: Adapts to organizations of all sizes, from small businesses to global enterprises.
Industries Served:
ISO 26262
FUNCTIONAL SAFETY FOR ROAD VEHICLES
ISO 26262 is the global standard for ensuring functional safety in automotive systems. It applies a risk-based approach across the lifecycle of safety-related systems, from concept to decommissioning, to minimize risks from electronic and software failures.
Why Choose Inflectra for ISO 26262 Compliance?
Adhering to ISO 26262 and ASPICE ensures both functional safety and process quality. Inflectra provides:
- Lifecycle Management: Ensures safety is prioritized from design to decommissioning.
- Risk-Driven Development: Focuses development efforts on mitigating the highest risks.
- Process Improvement: Leverages ASPICE to continuously enhance software quality.
Industries Served:
ISO 27001
INFORMATION SECURITY MANAGEMENT SYSTEMS (ISMS)
ISO 27001 provides a globally recognized framework for managing information security risks. It ensures the implementation of security controls to protect sensitive data, reduce cyber risks, and safeguard organizational assets.
Why Choose Inflectra for ISO 27001 Compliance?
Inflectra ensures end-to-end compliance with ISO 27001.
- Risk and Incident Management: Tracks and mitigates security risks with real-time dashboards and incident management tools.
- Comprehensive Security: Protects sensitive data and personal information with advanced encryption and access controls.
- Audit-Readiness: Generates reports and maintains audit trails to simplify compliance reviews.
- Cloud Security: Leverages AWS’s compliance with SOC2, PCI-DSS, and ISO 27001 to provide an industry-leading secure hosting environment.
Industries Served:
ISO 13485
QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES
ISO 13485 is the global standard for QMS in medical devices, ensuring safe, effective products that meet regulatory requirements with a focus on risk management, documentation, and process control.
How The Inflectra Platform Supports ISO 13485 Compliance
- QMS Integration: SpiraPlan facilitates end-to-end QMS processes, ensuring compliance across the lifecycle of medical devices.
- Risk Management Tools: Support early identification and analysis of risks and their control on product lifecycle.
- Software Lifecycle Compliance: Supports IEC 62304 for regulatory-compliant medical device software development.
- Regulatory Audit Support: Provides audit trails and documentation necessary for regulatory inspections and certifications.
Industries Served:
IEC 62304
MEDICAL DEVICE SOFTWARE LIFECYCLE PROCESSES
IEC 62304 is the global standard for medical device software development, defining SDLC requirements for design, testing, and risk management. Harmonized with FDA regulations and ISO 13485, it applies a risk-based approach for Class A, B, and C software.
How The Inflectra Platform Supports IEC 62304 Compliance
- Comprehensive Traceability: Links system requirements, design, risk mitigations, test cases, and defect logs, ensuring audit-ready traceability.
- Integrated Risk Management: Support early identification and analysis of risks and their control on product lifecycle
- V-Model Lifecycle Support: Implements IEC 62304's V-model, covering planning, design, implementation, and testing.
- Agile Integration: SpiraPlan enables iterative development while adhering to IEC 62304.
- Tool Validation: Provides workflows for validating development tools, meeting IEC 62304's requirements.
Industries Served:
ISO 20022:
UNIVERSAL FINANCIAL INDUSTRY MESSAGE SCHEME
ISO 20022 is a global standard for financial data exchange, enabling seamless communication across banking, investment, and insurance sectors. It improves interoperability, reduces risks, and streamlines cross-border transactions.
How The Inflectra Platform Supports ISO 20022 Compliance
Inflectra offers comprehensive solutions to facilitate ISO 20022 adoption:
- Requirements Management: Captures and manages detailed requirements to ensure alignment with ISO 20022 standards.
- Test Management: Develops and executes test cases to validate compliance with ISO 20022 messaging protocols.
- Risk Management: Identifies and mitigates risks associated with the implementation of ISO 20022, ensuring a smooth transition.
- Platform Compliance: Inflectra's solutions assist financial institutions in adopting ISO 20022 by providing tools that support the necessary development, testing, and validation processes.
Industries Served:
ISO 31000
RISK MANAGEMENT — GUIDELINES
ISO 31000 provides principles, a framework, and a process for managing risk. It is designed to help organizations identify, assess, and mitigate risks in a structured and systematic manner. ISO 31000 is applicable to any organization, regardless of size, industry, or sector, and improves decision-making.
How The Inflectra Platform Supports ISO 20022 Compliance
Inflectra offers comprehensive solutions to facilitate ISO 20022 adoption:
- Enhanced Decision-Making: Facilitates a structured framework to identify, analyze, and address risks, enabling informed decision-making at all levels of the organization.
- Stakeholder Confidence: Demonstrated commitment to robust risk management practices fosters trust among stakeholders, including customers, investors, and regulatory bodies.
- Effective Value Creation: Integrates risk management into organizational processes, helping to optimize resource allocation, reduce waste, and seize opportunities while mitigating threats.
- Improved Resilience: By proactively managing risks and their impact on product delivery, organizations can minimize disruptions adapting to manage change.
GDPR
GENERAL DATA PROTECTION REGULATION
GDPR is the European Union’s standard for personal data protection, emphasizing transparency, accountability, and enhanced individual rights over their data.
How Inflectra Supports GDPR Compliance
- Data Access Control: Provides tools for managing user permissions and ensuring secure data access.
- Data Subject Rights Management: Tracks and manages GDPR requirements like data deletion and portability requests.
- Transparent Data Processing Practices: Maintains clear and accessible data processing policies, ensuring customers are informed about how their data is handled.
- Platform Compliance: Inflectra’s cloud services are fully GDPR-compliant, with Data Protection Agreements (DPA) included in its Terms of Service (TOS).
FDA 21 CFR Part 11
ELECTRONIC RECORDS AND SIGNATURES
FDA 21 CFR Part 11 sets the criteria for electronic records and signatures to be trustworthy, reliable, and equivalent to paper records. Applicable to FDA- regulated industries, it ensures compliance in data integrity, security, audit trails, and electronic signatures.
How Inflectra Supports FDA 21 CFR Part 11 Compliance
- Complete Traceability: Links electronic records, test cases, risks, and defects to ensure compliance with Part 11 traceability mandates.
- Data Security: Protects electronic records with advanced encryption, access control, and secure signatures.
- Secure Audit Trails: Tracks changes with user details and timestamps for tamper-proof audit readiness.
- E-Signatures: Provides FDA-compliant electronic signatures for traceable and secure approvals.
- Access Control: Enforces role-based permissions and secure authentication to protect data.
- Validation Packages: Offers validation certificates for streamlined FDA submissions.
- Automated Testing: Integrates with Rapise to automate test case creation and reduce manual effort.
Industries Served:
HIPAA
HEALTH INSURANCE PORTABILITY AND ACCOUNTABILI TY ACT
HIPAA sets national standards for safeguarding sensitive patient health information (PHI). It requires organizations to implement strict administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and availability of electronic PHI (ePHI).
How Inflectra Supports HIPPA Compliance
- Comprehensive Security: Role-based access control, data encryption, and session timeouts ensure PHI is protected from unauthorized access and maintained with industry-standard safeguards.
- Audit-Ready Visibility: Automatic logging and detailed audit trails provide full transparency into user activity, simplifying compliance reviews and inspections.
- Integrated Risk and Hosting Management: Customizable workflows, secure hosting options, and tools for managing access, risks, and incidents align with HIPAA’s administrative and physical safeguard requirements.
- HIPAA Business Associate Agreement: Availability of BAAs as part of Inflectra software support contracts.
Industries Served:
EUDRALEX VOLUME 4
EU GUIDELINES FOR GOOD MANUFACTURING PRACTICE (GMP)
EudraLex Volume 4 outlines the EU’s GMP guidelines for medicinal products for human and veterinary use. It is divided into Part I for GMP basics and Part II for active substances, ensuring high-quality standards in manufacturing, testing, and distribution to protect patient safety and product efficacy.
How Inflectra Supports EudraLex Volume 4 Compliance
Inflectra helps companies align with GMP requirements by offering:
- GMP Traceability: Tracks and manages critical manufacturing data to align with GMP standards.
- Deviation Management: Logs deviations and corrective actions to ensure compliance.
- Audit-Ready Documentation: Generates traceability matrices, audit trails, and batch records for inspections.
- Risk and Quality Tools: Integrates risk management and quality assurance workflows.
- Validation Support: Facilitates process validation, tracking testing and outcomes.
Industries Served:
NIST
NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY
National Institute of Standards and Technology (NIST) provides frameworks like the NIST Cybersecurity Framework (CSF) and NIST SP 800-53 to manage risks and protect sensitive data. These standards ensure the confidentiality, integrity, and availability of information across industries.
How Inflectra Supports NIST Compliance
- Risk Management Tools: Identifies, evaluates, and mitigates risks in line with NIST’s Risk Management Framework (RMF).
- Access Control and Security: Implements role-based access, multi-factor authentication, and encryption to meet security requirements.
- Incident Tracking: Logs and resolves security incidents in accordance with NIST guidelines.
- Automated Documentation: Generates compliance reports and audit trails for inspections.
- Continuous Monitoring: Tracks vulnerabilities and compliance gaps with real-time dashboards.
Industries Served:
DORA
THE DIGITAL OPERATIONAL RESILIENCE ACT
DORA is a regulation enacted by the EU in 2025 to strengthen ICT risk management and operational resilience for financial entities and service providers. It emphasizes risk management, incident reporting, resilience testing, and third-party oversight to ensure operational continuity amidst digital risks.
How Inflectra Supports DORA Compliance
- Risk Management: Centralized tracking and automated risk scoring with dashboards for proactive monitoring.
- Incident Reporting: Streamlined tracking, regulatory reporting, and audit-ready workflows.
- Resilience Testing: Penetration testing and resilience simulations to ensure recovery readiness.
- Governance: Role-based dashboards deliver insights for informed decision-making.
Industries Served:
DO-178C
SOFTWARE CONSIDERATIONS IN AIRBORNE SYSTEMS AND EQUIPMENT CERTIFICATION
DO-178C is the industry standard for ensuring software reliability and safety in airborne systems. This standard mandates a rigorous software development lifecycle, focusing on requirements traceability, testing, and quality assurance to meet certification standards for aviation software.
How Inflectra Supports DO-178C Compliance
Inflectra platforms provide comprehensive tools (SpiraPlan) to streamline DO-178C compliance:
- End-to-End Traceability: Tracks requirements through design, implementation, and testing, ensuring complete coverage for certification.
- Test Management: Automates test case creation, execution, and reporting, enabling robust validation and verification processes.
- Configuration Management: Tracks changes with version control, meeting DO-178C’s transparency and accountability requirements.
- Compliance Reporting: Generates audit-ready reports and traceability matrices for seamless regulatory reviews.
Industries Served:
FMEA
FAILURE MODES AND EFFECTS ANALYSIS
FMEA is a systematic and structured approach used to identify, analyze, and prioritize potential failure modes in a process, product, or system. The primary purpose of FMEA is to improve reliability, safety, and quality by proactively identifying risks and implementing actions to mitigate them.
How Inflectra Supports FMEA
Inflectra enhances FMEA through its dedicated FMEA SpiraApp, offering the following features:
- Risk Priority Number (RPN) Calculation: Automatically computes the RPN by multiplying user-defined values for Probability, Impact, and Detectability, aiding in the prioritization of potential failure modes.
- Custom Properties for Detectability and RPN: Allows the creation of custom fields to capture Detectability ratings and store calculated RPN values, facilitating detailed risk assessments.
- Top Open Risks Widget: Provides a dashboard widget that displays the top open risks ranked by RPN, enabling teams to focus on the most critical issues.
- Integration with Risk Management Module: Seamlessly integrates with SpiraPlan's risk management features, allowing for comprehensive tracking and mitigation of identified risks.
Industries Served:
GAMP
GOOD AUTOMATED MANUFACTURING PRACTICE
GAMP guidelines by ISPE ensure computerized systems in pharmaceuticals are safe, effective, and compliant with regulatory standards, focusing on patient safety, product quality, and data integrity.
How Inflectra Supports GAMP
- Requirements Management: Tracks and manages system requirements to ensure compliance with GAMP principles.
- Risk Assessment: Incorporates risk-based approaches for evaluating and addressing system vulnerabilities.
- Test Management: Provides robust testing tools to verify and validate system functionality against GAMP requirements.
- End-to-End Traceability: Links requirements, tests, and risks for comprehensive traceability and regulatory compliance.
- Lifecycle Documentation: Supports documentation and control of processes throughout the system's lifecycle.
Industries Served:
Conclusion
Inflectra transforms compliance chaos into clarity. Our platform automates regulatory workflows, centralizes documentation, and gives you real-time visibility—ensuring you’re always audit-ready, with half the effort
Don’t wait for your next audit to find the gaps—take control of compliance now