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Compliance

Regardless of the industry, size or maturity of the organization, SoftExpert offers an integrated platform to support compliance management, enabling organizations to meet norms, standards and regulations in a structured, auditable manner that is aligned with global best practices.

Standards

AS9100

AS9100

Streamline and standardize legal and regulatory compliance management in accordance with AS9100/EN9100 requirements using a comprehensive solution, ensuring quality, safety, and consistency in the delivery of aerospace products.

BPMN

BPMN

Maximize the efficiency and security of your processes with SoftExpert Suite using BPMN [Business Process Model and Notation].

BSC

BSC

Achieve your strategic objectives effectively with Balanced Scorecard (BSC). Centralize, monitor, and evaluate organizational performance against key performance indicators (KPIs) to ensure the integrity and efficiency of processes across your organization.

CBOK

CBOK

Bring together the best practices, skills and competencies necessary for excellence in Business Process Management (BPM) with SoftExpert Suite.

COBIT

COBIT

Optimize resources and standardize processes with COBIT, an IT governance management method that provides a holistic view of your business and contributes to the optimal functioning of the organization.

COSO

COSO

Transform governance management with an integrated and innovative tool. Coordinate, enhance, and oversee compliance and internal audit processes, strengthening transparency and organizational performance with COSO risk management software.

FSSC 22000

FSSC 22000

Ensure maximum food safety and efficiency and compliance with FSSC 22000 with SoftExpert Suite.

IATF 16949

IATF 16949

Drive compliance with IATF 16949 and transform automotive quality management. Centralize documents, manage CAPA, FMEA, and APQP, and optimize processes to reduce failures, costs, and risks with SoftExpert’s integrated platform.

ISO 10015

ISO 10015

Align training and skills with strategic objectives, maximizing performance and ensuring compliance with ISO 10015.

ISO 13485

ISO 13485

Manage documents, quality control activities and process monitoring, ensuring the safety and effectiveness of medical devices with SoftExpert Suite.

ISO 14001

ISO 14001

Maximize sustainability and reduce your company's environmental impact. Centralize, manage and monitor ISO 14001 legal and regulatory requirements, ensuring the integrity and efficiency of environmental processes in your organization.

ISO 14971

ISO 14971

Implement robust and effective processes for medical device and IVD risk management. Be aligned with the requirements and best practices of the ISO 14971 standard, ensuring the safety and effectiveness of your products throughout their entire life cycle.

ISO 15189

ISO 15189

SoftExpert Suite helps you with everything from document management to quality control to ensure the excellence and reliability of laboratory services in accordance with ISO 15189.

ISO 19011

ISO 19011

Improve audit and management practices with precision and clarity. Coordinate, perform and monitor internal and external audit procedures, ensuring compliance and continuous improvement. Raise the standard of audits with an integrated and dynamic solution.

ISO 20000

ISO 20000

ISO 2000, Incident Management Process promotes IT compliance and excellence. Transforming service management and maximize efficiency, reducing costs and risks. Meet all the ISO 20000 Certification Requirements.

ISO 22000

ISO 22000

Strengthen your food safety management by facilitating compliance with ISO 22000 and the updated PRPs of ISO 22002:2025. Centralize documents, integrate processes, and streamline audits efficiently.

ISO 22301

ISO 22301

Implement comprehensive management in your company with a solution that monitors all ISO 22301 requirements, such as risks, incidents, performance indicators and process flows. Be better prepared to prevent disruptive events and improve efficiency, ensuring the continuity of operations.

ISO 26000

ISO 26000

Improve corporate social responsibility with integrity and innovation. Manage, integrate and monitor sustainability and business ethics initiatives, aligning them with global social responsibility practices.

ISO 27001

ISO 27001

Achieve excellence and compliance with the ISO 27001 standard. Manage requirements, monitor risks, and optimize responses to information security incidents with agility and efficiency on a single cloud platform.

ISO 31000

ISO 31000

Minimize risks and maximize opportunities with ISO 31000 software . Discover the solution to promote efficient risk management and demonstrate responsibility in business continuity and operational security.

ISO 37001

ISO 37001

Enhance your organization's credibility by fully adhering to ISO 37001. Demonstrate a clear commitment to transparency, governance, and corporate responsibility to combat bribery and foster an ethical business culture.

ISO 42001

ISO 42001

Achieve ISO 42001 compliance with a cloud-based Artificial Intelligence Management System (AIMS).

ISO 45001

ISO 45001

Reduce costs and improve effectiveness and productivity. Discover the solution to strengthen legal compliance and demonstrate your organization's commitment to a safe and healthy work environment.

ISO 50001

ISO 50001

Reduce costs and waste, optimize processes, and strengthen sustainability with an efficient and continuously improving energy management system.

ISO 55000

ISO 55000

Improve the control of your assets with a robust solution that monitors the equipment lifecycle, increasing management system efficiency while reducing rework and process waste.

ISO 9001

ISO 9001

Achieve excellence and compliance with the ISO 9001 standard. Manage documents, optimize processes with AI, and enhance customer satisfaction with agility and efficiency.

ISO/IEC 17025

ISO/IEC 17025

Ensure the quality and reliability of your test and calibration results with SoftExpert Suite in accordance with the ISO/IEC 17025 standard requirements.

ITIL

ITIL

Achieve effective IT process management with ITIL, a practical, comprehensive, and consistent framework that helps you drive business effectiveness and service management efficiency.

PMBOK

PMBOK

Ensure efficient project management with SoftExpert Suite aligned with PMBOK compliant project management best practices.

Six Sigma

Six Sigma

Use SoftExpert Suite to implement and ensure a quality management and continuous improvement practices aligned with Six Sigma business management methodology principles.

Regulations

FDA 21 CFR Part 11

FDA 21 CFR Part 11

Manage electronic records and signatures with data traceability and security. SoftExpert Suite supports organizations in implementing best practices aligned with FDA 21 CFR Part 11, helping reduce risks and streamline audits.

FDA 21 CFR Part 820

FDA 21 CFR Part 820

Achieve regulatory compliance and medical device excellence, ensuring quality and safety with robust management of FDA 21 CFR Part 820 requirements.

GDPR

GDPR

Ensure compliance with GDPR and protect personal data with SoftExpert Suite, the complete solution for privacy and information security management.

SOX

SOX

Ensure financial transparency and corporate responsibility. Discover the solution to streamline regulatory compliance and reaffirm your commitment to financial reporting integrity and risk mitigation.