Software

Verification  &Validation

 

 

Process development

Risk-based V&V Planning and review

Test Outsourcing

Test Automation - we are a Ranorex Silver Partner for FDA regulated industry

Product software and FDA submission documentation

Production and Quality System Software

Retrospective Validation

Electronic record and signature systems – 21 CFR Part 11

Embedded Systems

Mobile Medical Apps

Standalone Software and Medical Device Data Systems (MDDS)

FDA Compliance and EN 62304 Conformance

Tailored to your process & preferences

Optimized for efficiency – not one size fits all

Call 781-721-2921 or email brian@softwarecpr.com  to talk to one of our experts

 

 

 

We will work with you to plan your software verification and validation (prospectively or retrospectively). Our involvement can range from V&V planning and procedures to detailed test case design execution for regulated products or Production and Quality System Software including development tools and electronic record and signature systems. Our clients range from large corporations to small start-up companies. Many companies find that having us provide hands-on support for all of their validation activities helps speed up product submissions and alleviates the need for hiring extra staff.

Our approach is risk-based, emphasizing risk analysis early in the process to help prevent costly changes late in the development cycle and to provide the safest products possible. Emphasizing a risk-based approach for V&V activities can help you spend less time on the least risky areas and tools, concentrating your efforts on critical areas.

Our involvement is tailored to your needs, your products, your regulatory perspective, and your business objectives – services range from training to review to hands-on testing.

Our staff has years of experience managing, developing and testing regulated products. Alan Kusinitz, SoftwareCPR¨Ős Managing Partner, is the lead instructor for public AAMI/FDA Software Validation Training courses and has performed internal training for FDA and Health Canada staff. We understand regulatory agency expectations and standards conformance including how best to articulate your approach.

V&V Documentation – We can help prepare the software documents for Test Plans, Test Cases, Test Summaries, and Trace/coverage maps as well as specifications, risk analysis and all other required documentation.

 

Code Review – Our staff can establish a review process for your organization, help you create software coding guidelines, or perform independent code reviews

Unit Testing – Our staff can recommend unit test strategies and develop unit test software for your target environment or on standard PC environments (e.g. Windows).

Static Test – Our staff can establish a static test process for your organization or perform independent static reviews using tools such as LDRA, other supporting tools or your own tools.

Software Test Planning, Test Execution and Traceability – Our staff can help you plan and execute unit, integration and system tests. Testing work may be done at your site, or off-site. Testing work also includes documents to trace the requirements, risk mitigations and software components to the tests that cover these areas.

User/Usability Test Planning, Test Execution and Traceability – Our staff can provide training or help you plan and execute User or Usability tests.  Testing work also includes documents to trace the user or device-level requirements to the tests that cover these areas.

Automated Testing – Our staff can recommend  and implement automated test strategies, even for embedded systems!  Many Agile approaches depend heavily upon test automation and our team can assist or provide turn-key systems for automating your software verification testing.

Process documents – We can help you create the necessary plans and procedures that are essential for software V&V compliance.