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Compliance

If you deliver products with software in a regulated industry such as medical devices (governed by the FDA’s CFR 21 Part 820) or aerospace (impacted by the FAA’s DO-178B) you face significant compliance requirements that drive up costs, lengthen cycle times and drive increased risk for your organization. Other governance demands like ITIL, CMMI and SOX can also have a major impact on your organization’s development and delivery of software, regardless of your industry.

The demands of compliance and governance tend towards similar business challenges for your organization; you must document and report on your processes; you must show traceability across assets and activities; you must prove that risks have been mitigated while disclosing all verification and validation results; and you must keep a complete record of what changes were made, when and by whom. To consistently address your compliance needs without excessive cost and effort, you must clearly understand the challenges as well as how a solution can address them.

The table below lists common challenges associated with compliance and governance, along with the MKS platform capabilities that will help you solve them.

 

Issue MKS Solution Capability and Benefits
Manual and Inconsistent Processes
Audit costs go up significantly when processes are not well documented or are manual. Automation plays a major role in the cost and effort required for compliance.
  • End to end process automation and enforcement
  • Identify bottlenecks with comprehensive metrics dashboards
  • Accurate reporting across all processes and assets
Manual Document Management
When requirements, specifications, risks, test cases, etc, are managed manually in spreadsheets and word processors, change management, traceability, and impact analysis are all severely hindered.
  • Best in industry requirements management with advanced traceability support
  • Automated change tracking and history
  • Configurable notification services
Inability to Manage Growing Product Lines
Documented and automated reuse across product variants improves quality and reduces the cost of compliance.
  • Advanced reuse of all lifecycle assets including features, requirements, code, test cases, test results, etc.
  • Perform rapid impact analysis across all products variants and product lines, based on real-time data
  • Automated propagation of changes and fixes across applicable variants
Disconnected Tools and Repositories
Data redundancy, siloed processes, and disconnected tools leads to lack of auditability and errors.
  • A single platform for managing all activities and assets
  • An enterprise integration gateway ensures assets are accessible and relate-able while reducing data redundancy
  • Generate needed reports and documentation in mouse-clicks instead of person-weeks
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