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Product Software Validation



Product Software Validation

ADB Automation and Validation Group offers a wide range of product software validation that guarantees reliability, cost effective and high-quality systems with the shortest turn-around time. Our services offer an objective evaluation of software products throughout the software development life cycle (SDLC) to detect flaws at the outset.

ADB conducts formal product software validation of class I, II, and III medical devices. We use a well-structured approach for validation to make sure software effectiveness and reliability. Our team of engineers is certified and experienced in FDA regulations, and will ensure your product software meets the appropriate regulatory requirements. The product software validation services include:

  • Validation testing
  • Regression testing
  • Traceability analysis
  • OTSS (Off-the-Shelf Software Validation)
  • Automated testing

We provide a full complement of product software validation and verification services such as code inspections, formal validation, design reviews, test plan development, and off-the-shelf software formal testing for medical products as per the Food and Drug Administration guidelines. We assist in validating your product software to assure you are compliant with all 21 CFR part II rules. We offer validation packages that have the following:

  • Installation Qualification (IQ) - IQ ensures that the software is installed and configured correctly
  • Operational Qualification (OQ) - OQ verifies if the software is functioning as per the pre-defined specifications once installed and configured on the end-users hardware.
  • Performance Qualification (PQ) - PQ shows and documents that the product software will perfectly perform as per the pre-defined software specification.

The benefits of using ADB product software validation services:

  • Timely detection and modification of product software anomalies 
  • Advanced software development and maintenance procedures
  • Improved management insight into product and process risk
  • Process upgrading support
  • Timely assessment of system and software performance
  • Professional support in life cycle process
  • Objective scrutiny of software and system to ensure conformity to regulations and certification process




Testimonial / What Our Client Say

Andre and his team were professional, focused and sensitive to the timing issues associated with my project. Most importantly, after the project completed Andre and his team did not disappear. As I needed answers and follow up information, his team followed up in a timely and accurate manner. I look forward to using the services again and would recommend them highly.

Erik Emerson, President & CEO at Symplmed

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