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Go-to Microsoft partner for requirements management since 2015

Azure DevOps

Standards

Learn how Modern Requirements4DevOps is aligned with popular industry standards

Managing ISO 26262 Compliance with Modern Requirements

Easily manage ISO 26262 compliance while accelerating development cycle
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Managing ASPICE Compliance with Modern Requirements

Managing ASPICE Compliance with Modern Requirements Automotive Software Performance Improvement
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21 CFR Part 11: Frequently Asked Questions

A CFR Part 11 questions and answers blog by Modern
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Facilitate the Medical Device Design Controls with Modern Requirements

Achieve quicker compliance, shorter development cycle times, and faster value
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Managing ISO 17491 Compliance within Azure DevOps using Modern Requirements

Comply with ISO 17491 in an automated and efficient manner
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Compliance Matrix

Standards Description Industry Relevant Features Feature Description MR4DevOps Feature
SOC2 This is a standard for service organizations that handle customer data. SOC2 requires that organizations establish and maintain a system of controls to ensure the confidentiality, integrity, and availability of customer data. Requirements management is an important part of these controls, as it ensures that customer requirements for data handling and protection are met. General Access Control Access controls to ensure that only authorized users can access data. Access controls should be in place to ensure that only authorized individuals are granted access to view or modify requirements or other sensitive data. Smart Docs, CoPilot4DevOps
      Requirements Gathering Ability to gather and document requirements from stakeholders, including identifying the needs and expectations of the system or service under review Smart Docs, FAQ
      Requirements Management Ability to manage and maintain the requirements throughout the development process, including version control, change management, and approval workflows Versioning, Impact Assessment and Approval
      Traceability Ability to establish and maintain traceability between requirements and other project artifacts, such as design, testing, and documentation Traceability Matrix
      Testing Ability to design and execute tests to verify that the system or service under review meets the requirements and specifications Test Hub
      Documentation Ability to document the requirements, design, testing, and other project artifacts in a clear and concise manner Smart Docs, Simulation, Smart Reports, Smart Note and Email
      Security Ability to ensure the security and confidentiality of the requirements and other project artifacts, as well as the system or service under review Security and Access Control
      Collaboration Ability to enable collaboration among team members and stakeholders, including sharing and discussing project artifacts Smart Docs, Simulation, Smart Reports, Smart Note, Email and Review
      Auditing Audit logging to record any changes made to requirements. Audit logs should be maintained to provide an audit trail and flag all changes made to requirements, including who made the change and when it was made. Traceability Matrix and Review
      Reporting Reporting capabilities to provide evidence of compliance. The requirements management tool should be able to produce reports that provide evidence of compliance with SOC2, such as reports on access controls or audit logs. Smart Reports
Standards Description Industry Relevant Features Feature Description MR4DevOps Feature
ISO 9001 This is an international standard for quality management systems. It requires that an organization establish a process for managing its requirements and ensure that they are met throughout the product or service lifecycle. General Traceability Ability to trace requirements to their source Traceability Matrix
      Change Management Ability to track and manage changes to requirements Versioning, Impact Assessment and Approval
      Version Control Ability to track versions of requirements Versioning, Impact Assessment and Baseline
      Baseline Management Ability to manage and track approved requirements Baseline
      Requirements Analysis Ability to analyze and validate requirements Requirements Analysis
      Requirements Collaboration Ability to collaborate and share requirements Smart Docs, Simulation, Smart Reports, Smart Note and Email
      Requirements Reporting AAbility to generate reports on requirements Smart Reports
Standards Description Industry Relevant Features Feature Description MR4DevOps Feature
ISO 9000 ISO 9000 requires that organizations establish a process for managing their requirements and ensure that they are met throughout the product or service lifecycle. General Documented requirements The organization must establish and maintain documented requirements for its products or services, including those related to quality. Smart Docs, Smart Note and Email
      Requirements review The organization must review the documented requirements before they are finalized to ensure that they meet the customer’s needs. Review and Approval
      Requirements validation The organization must validate the requirements to ensure that they are complete, correct, and unambiguous. FAQ, CoPilot4DevOps, Review and Approval
      Requirements changes The organization must have a process in place for managing changes to the documented requirements. Baseline, Versioning and Impact Assessment
      Requirements traceability The organization must establish and maintain traceability between the requirements and the product or service design and development stages. Traceability Matrix and Coverage Analysis
      Requirements verification The organization must verify that the product or service meets the documented requirements. Test Hub, Review and Approval
      Requirements acceptance The organization must obtain customer acceptance of the product or service in accordance with the documented requirements. Test Hub, Review and Approval
Standard
Description
Industry
Relevant Features
Feature Description
MR4DevOps Feature
ISO 26262
ISO 26262 requires that organizations establish a process for managing the safety requirements of their systems, including the management of safety requirements throughout the development lifecycle.
General
Traceability
Ability to trace requirements and their implementation throughout the development process
Baseline Management
Ability to manage multiple versions of requirements and their associated artifacts
Change Management
Ability to manage changes to requirements and associated artifacts throughout the development process
Change Management. Versioning and Impact Assessment
Review and Approval
Ability to review and approve requirements and associated artifacts prior to implementation
Requirements Validation
Ability to validate requirements and ensure they are complete, consistent, and unambiguous
Requirements Reuse
Ability to reuse requirements across multiple projects or products
Requirements Reuse
Requirements Prioritization
Ability to prioritize requirements based on their importance and impact on the system
Requirements Prioritization
Requirements Traceability Reporting
Ability to generate reports that show the traceability of requirements and their implementation throughout the development process
Requirements Change Impact Analysis
Ability to analyze the impact of changes to requirements on the system and its associated artifacts
Standard
Description
Industry
Relevant Features
Feature Description
MR4DevOps Feature
CFR Part 11
This is a regulation that governs electronic records and signatures in the pharmaceutical and medical device industries. CFR Part 11 requires that organizations manage their requirements for electronic records and signatures and ensure that they are accurate, complete, and secure.
Medical
Electronic Records
Ability to manage electronic records in a secure, reliable, and auditable manner
Electronic Records Management
Electronic Signatures
Ability to capture and manage electronic signatures in a secure, reliable, and auditable manner
Standard
Description
Industry
Relevant Features
Feature Description
MR4DevOps Feature
ISO 13485
ISO 13485 requires that organizations establish a process for managing the requirements for their medical devices and ensure that they are safe, effective, and meet regulatory requirements.
Medical
Risk management
Risk management capabilities to identify and manage risks related to medical device requirements. The tool should provide risk management capabilities that allow risks related to medical device requirements to be identified and managed.
Traceability
Ability to trace requirements and their implementation throughout the development process
Design and Development Planning
Ability to plan and manage the design and development process, including requirements management and verification
Simulation, Diagramming and Usecase
Design Input
Ability to capture and manage requirements and input from stakeholders and other sources
Design Output
Ability to manage design output and ensure that it meets all applicable requirements and specifications
Design Verification and Validation
Ability to verify and validate the design to ensure that it meets all applicable requirements and specifications
Design Changes
Ability to manage changes to the design throughout the development process, including their impact on other requirements and specifications
Document Control
Ability to manage documents and records associated with the product or service in a controlled and auditable manner
Supplier Management
Ability to manage suppliers and ensure that they meet all applicable requirements and specifications
Supplier Management
Training and Competence
Ability to provide training and ensure the competence of personnel involved in the design, development, and production or service delivery process
Document Management
Document management capabilities to manage documentation related to medical device requirements: The tool should provide document management capabilities that allow documentation related to medical device requirements to be managed and tracked.
Standard
Description
Industry
Relevant Features
Feature Description
MR4DevOps Feature
ISO 14971
ISO 14971 requires that organizations establish a process for managing the requirements for risk management and ensure that risks are identified, analyzed, evaluated, and controlled throughout the product lifecycle.
General
Risk management
The tool needs to identify and manage risks related to the safety of medical devices throughout the development process, including the use of risk analysis techniques and risk management plans.
Risk Analysis
Ability to analyze and evaluate risks associated with medical devices, including identifying hazards and assessing their severity and probability of occurrence
Post-Market Surveillance
Ability to monitor and report on the performance and safety of medical devices after they have been released to the market
Production and Post-Production Information
Ability to manage information related to the production and post-production of medical devices, including changes to the device and any associated risks
Document Control
Ability to manage documents and records associated with medical devices in a controlled and auditable manner
Traceability
Ability to trace requirements and their implementation throughout the development process, including the identification of risks and risk control measures
Design and Development Planning
Ability to plan and manage the design and development process for medical devices, including requirements management and verification
Simulation, Diagramming and Usecase
Design Input
Ability to capture and manage requirements and input from stakeholders and other sources for medical devices
Traceability features
The tool needs to enable the linking of safety requirements to other requirements and work products to ensure that safety requirements are met.
Work item linking
Reporting capabilities
The tool needs to provide evidence of compliance with ISO 14971 by generating reports on risk management activities.
Standard
Description
Industry
Relevant Features
Feature Description
MR4DevOps Feature
ISO 17491
ISO 17491 specifies a test method for determining the resistance of protective clothing against penetration by chemicals.
General
Traceability features
The tool needs to enable the linking of software requirements to system requirements and design to ensure that software requirements are met.
Requirements Documentation
Ability to document requirements in a clear and concise manner
Design and Development Planning
Ability to plan and manage the design and development process for medical devices, including requirements management and verification
Simulation, Diagramming and Usecase
Reporting capabilities
The tool needs to provide evidence of compliance with ISO 14971 by generating reports on risk management activities.
Change Management
Ability to manage changes to project artifacts, including requirements, design, and code
Standard
Description
Industry
Relevant Features
Feature Description
MR4DevOps Feature
ASPICE
(Automotive Software Process Improvement Capability determination) is an industry-standard guideline for evaluating software development processes.
Automotive and Manufacturing
Traceability features
The tool needs to enable the linking of software requirements to system requirements and design to ensure that software requirements are met.
Requirements Elicitation
Ability to identify, collect and document requirements from stakeholders
Requirements Analysis
Ability to analyze requirements for consistency, completeness, feasibility, and testability
Requirements Documentation
Ability to document requirements in a clear and concise manner
Requirements Management
Ability to manage changes to requirements, including version control and approval workflows
Requirements Verification
Ability to verify that requirements have been implemented correctly and meet the specified criteria
Change Management
Ability to manage changes to project artifacts, including requirements, design, and code
Metrics and Analysis
Ability to collect and analyze metrics related to project progress, quality, and efficiency
Metrics and Analysis
Collaboration
Ability to enable collaboration among team members and stakeholders, including sharing and discussing project artifacts
Configuration
The tool needs to control and document changes to software requirements, including who made the changes and why.
Test Plans
Capability to manage work products related to software requirements: The tool needs to provide support for work products related to software requirements, such as test plans and test cases.

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