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Requirements Management Software

Manage and trace requirements across systems with ease

 

Duplicating requirements across systems creates rework and wastes valuable time and resources.

Without an easy way to manage and trace requirements, teams are forced to copy and paste from Jira or Git into another system, like an eQMS or ALM. This wastes valuable developer time and increases the risk of developer attrition.

Connected Requirements Management

Manage requirements from wherever you work

Create your requirements in Jira or the tool of your choice. You’ll have full requirements visibility and traceability within both Jira and Ketryx.

Trace requirements from Jira, source code, ALM, or PLM

  • Use the pre-configured issue type “Requirement” in Jira to create new requirements with ease
  • Trace requirements and see them progress as their issue status changes

Establish links between requirements

  • Set the Parent requirements in Jira as appropriate — these constitute the design input for each requirement
  • Ensure that requirements are traceable to all other needed items, like specifications and tests 
  • Create new risk items and trace them to the requirement if new risks emerge from a requirement

See requirements traceability in real time

  • Automatically maintain a real-time requirements traceability matrix across all connected systems so it’s always up to date — no manual work required 
  • See and resolve coverage gaps across systems at a glance

Create documentation automatically

  • Generate artifacts directly from requirements, like your change management file, risk control matrix, risk management file, risk matrix, SRS, SDS, test plan, and traceability matrix
  • Automatically produce fully configurable submission-ready documentation at the end of each development cycle

Control closed requirements

  • Automatically move the Requirement to a Closed state after all approval rules have been passed (all required groups have approved the Requirement)
  • Automatically add a comment to the Jira issue with a link to the effective controlled record in Ketryx

Streamline change management

  • See a detailed record of what changes were made, when they were made, and who made them
  • Automate your Part 11-compliant audit trail
  • Get context for why certain changes were made with audit-ready documentation
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Configure custom approval rules

  • Configure approval rules and groups to match your workflows and SOPs 
  • Include the item assignee (author of the requirement), product managers, R&D leads, and quality managers in your approval groups as needed