Best Requirements Management Software for Apache Subversion

Aligned provides a purpose built eQMS and design management solution created exclusively for medical device and in vitro diagnostic manufacturers. It addresses the demands of global regulatory compliance while removing the friction typically associated with traditional QMS tools. The system enables organizations to operate in line with key regulations and standards including ISO 13485, FDA QSMR, EU MDR, and IVDR. It is relied upon by experienced quality and development professionals who require transparency, control, and consistency across all stages of product development and post market activities. Aligned brings quality management and design control together in a single coherent platform that supports cross functional teamwork. Quality, regulatory, R and D, and leadership teams work within the same controlled environment, where requirements, design data, verification and validation activities, risk files, and changes are inherently linked. This built in connectivity delivers complete traceability and clear evidence for audits, inspections, and regulatory submissions.

ReqView is an industry standard requirements management tool that allows SW, HW, and Systems (such as ISO 29148) to be managed in compliance with industry standards. It supports V-Model, end-to-end tracability, and version control in Git/SVN. It integrates with Jira, ReqIF and ReqIF. ReqView allows you to get started quickly. Import your documents, then elaborate on requirements, risks and tests. Customize the attributes of requirements according to your workflow. Link related requirements to verification & Validation, safety risks, and other factors. Create traceability reports in MS Word, Excel PDF or HTML formats, and share them with reviewers. Estimate the impact of changes in order to avoid unexpected costs. Prove that safety risks have been mitigated and that all requirements are met. Improve the overall quality of your product.