Go-to Microsoft partner for requirements management since 2015

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

Managing ASPICE Compliance with Modern Requirements

Managing ASPICE Compliance with Modern Requirements Automotive Software Performance Improvement

21 CFR Part 11: Frequently Asked Questions

A CFR Part 11 questions and answers blog by Modern Requirements

Facilitate the Medical Device Design Controls with Modern Requirements

Achieve quicker compliance, shorter development cycle times, and faster value delivery

Managing ISO 17491 Compliance within Azure DevOps using Modern Requirements

Comply with ISO 17491 in an automated and efficient manner

Covered Standards

Standards
SOC2
ISO 9001
ISO 9000
ISO 26262
CFR Part 11
ISO 13485
ISO 14971
ISO 17491
ASPICE

Compliance Matrix

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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

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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

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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

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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	Traceability Matrix
			Baseline Management	Ability to manage multiple versions of requirements and their associated artifacts	Baseline
			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	Review and Approval
			Requirements Validation	Ability to validate requirements and ensure they are complete, consistent, and unambiguous	FAQ, CoPilot4DevOps, Review and Approval
			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	Traceability Analysis
			Requirements Change Impact Analysis	Ability to analyze the impact of changes to requirements on the system and its associated artifacts	Impact Assessment

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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	Electronic Signatures

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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.	Smart Docs, Baseline, Requirements Reuse, Traceability Analysis and MatCal
			Traceability	Ability to trace requirements and their implementation throughout the development process	Traceability Matrix
			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	FAQ and Email
			Design Output	Ability to manage design output and ensure that it meets all applicable requirements and specifications	Test Hub
			Design Verification and Validation	Ability to verify and validate the design to ensure that it meets all applicable requirements and specifications	Review and Approval
			Design Changes	Ability to manage changes to the design throughout the development process, including their impact on other requirements and specifications	Baseline, Versioning and Impact Assessment
			Document Control	Ability to manage documents and records associated with the product or service in a controlled and auditable manner	Smart Docs, Smart Note and Smart Reports
			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	Review and Approval
			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.	Smart Docs and Smart Note

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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.	Smart Docs, Baseline, Requirements Reuse, Traceability Matrix and MatCal
			Risk Analysis	Ability to analyze and evaluate risks associated with medical devices, including identifying hazards and assessing their severity and probability of occurrence	Impact Assessment
			Post-Market Surveillance	Ability to monitor and report on the performance and safety of medical devices after they have been released to the market	Test Hub
			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	Baseline, Versioning and Impact Assessment
			Document Control	Ability to manage documents and records associated with medical devices in a controlled and auditable manner	Smart Docs
			Traceability	Ability to trace requirements and their implementation throughout the development process, including the identification of risks and risk control measures	Traceability Matrix
			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	FAQ and Email
			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.	Smart Reports

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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.	Traceability Matrix
			Requirements Documentation	Ability to document requirements in a clear and concise manner	Smart Docs and CoPilot4DevOps
			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.	Smart Reports
			Change Management	Ability to manage changes to project artifacts, including requirements, design, and code	Baseline

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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.	Traceability Matrix
			Requirements Elicitation	Ability to identify, collect and document requirements from stakeholders	FAQ and Email
			Requirements Analysis	Ability to analyze requirements for consistency, completeness, feasibility, and testability	Review and Approval
			Requirements Documentation	Ability to document requirements in a clear and concise manner	Smart Docs and CoPilot4DevOps
			Requirements Management	Ability to manage changes to requirements, including version control and approval workflows	Versioning and Approval
			Requirements Verification	Ability to verify that requirements have been implemented correctly and meet the specified criteria	Test Hub
			Change Management	Ability to manage changes to project artifacts, including requirements, design, and code	Baseline, Versioning and Impact Assessment
			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	Smart Docs, Simulation, Smart Reports, Smart Note, Email and Review
			Configuration	The tool needs to control and document changes to software requirements, including who made the changes and why.	Impact Assessment
			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.	Test Hub