FDA

Parasoft supports FDA compliance by:

• Delivering the industry's most comprehensive defect prevention and detection capabilities in an integrated solution: Parasoft provides out-of-the-box automation of the validation practices named in the FDA's General Principles of Software Validation, including:
  • Static code analysis -coding standards, data flow, metrics.
  • Dynamic analysis - unit/component testing, integration testing, functional testing, memory error detection, coverage analysis, continuous regression testing.
  • Peer code review (and document review) process automation.
• Orchestrating a traceable policy-based compliance process: Parasoft's policy-based approach establishes the organization's expectations for quality, leverages an automated infrastructure to ensure consistent, unobtrusive policy application, and automatically monitors policy compliance for visibility and auditability. Parasoft's unique automated infrastructure orchestrates both automated and manual compliance tasks and tracks the execution of all policy based tasks, analyses, and approvals/sign-off tasks.
• Leveraging 20+ years of experience establishing sustainable, repeatable, predictable quality processes: With extensive experience helping top organizations implement a broad range of validation and verification practices, Parasoft knows what it takes to ensure adoption and establish a sustainable, repeatable, and predictable process.
• Integrating compliance tasks into the workflow and across the SDLC: Parasoft establishes a continuous compliance process that ensures compliance tasks begin early and are deployed across every stage of the SDLC, as recommended by the FDA. We've learned that even the best tool eventually becomes shelfware if it is not integrated into a sustainable process. To ensure that the compliance process remains on track and does not disrupt project progress, Parasoft ingrains compliance tasks into the team's existing workflow and automates them so team members can focus on tasks that truly require human intelligence.
• Delivering extensive reporting for documentation and process improvement: Our centralized reporting system provides real-time visibility into overall compliance status and processes, documents compliance efforts, and helps you determine what additional actions are needed to ensure continued compliance.

IEC 62304

Software is often an integral part of MEDICAL DEVICE technology. Establishing the SAFETY and effectiveness of MEDICAL DEVICE containing software requires knowlage of what the software is intended to do and demonstration that the use of the software fulfills those intentions without causing any unacceptable RISKS.

IEC 62304 standard provides a framework of life cycle PROCESSES with ACTIVITIES and TASKS necessary for the safe design and maintenance of MEDICAL DEVICE SOFTWARE. This standard provides requirements for each life cycle PROCESS. Each life cycle PROCESS is further divided into a set of ACTIVITIES with most ACTIVITIES further divided into a set of TASKS.

Here is how Parasoft Quality Solution helps to meet IEC 62304 requirements (* - chapters ids of IEC 62304 ed 1.0)

Parasoft Concerto

• 5.2* Software Requirements Analysis - Requirements management
• 5.7.4 Software System test procedures trace to software requirements - Tests to tasks, PRs, FRs, requirements connection
• 5.7.4 Defects traceability - Bug Tracking System connection
• 5.6.6 Regression tests - Manual tests

Parasoft C++test / dotTEST / Jtest

• 5.5.2 Software unit verification - Unit Tests
• 5.6 Software integration and integration testing - Application Hosted Tests (dotTEST), Functional tests (SOAtest)
• 5.7.3 Retest after changes - Server tools
• 5.6.6 Regression tests - Server tools
• 5.5.3 Software unit acceptance criteria - Static Analysis, Metrics, Bug Detective
• 5.5.2 Test procedures shall be evaluated for correctness - Code Review
• 5.6.7 Integration test record contents - Reports, Concerto reports

IEC 62304 does not impose specific set of static analysis rules, however Parasoft can provide a template of Test Configuration with most valuable ones.