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Modular, Configurable, Scalable, Easy-to-Use

Grand Avenue Software provides the industry-leading quality management software solution for medical product companies. We are the affordable, scalable, and efficient eQMS deployed by med-tech innovators and leaders around the world. Our team has extensive experience in software development, Software as a Service (SaaS) delivery, and quality compliance, specifically for the life sciences industries. We work hand-in-hand with startups, emerging growth and established companies to navigate the complex regulatory affairs (RA) and quality assurance (QA) environment.  With Grand Avenue, compliance is assured, your budget is preserved.

Our Solution Suite

Business Advantages

Business Benefits of Compliance through Grand Avenue:

  • Achieves compliance quickly.
  • Delivers a high return on investment with rapid deployment and low cost of ownership.
  • Reduces overall costs and shortens time-to-market.
  • Establishes a solid compliance foundation that grows and evolves with your business.
  • Delivers for startup and early stage companies.
  • Scales to the needs of multi-division and multi-national organizations.

System Capabilities

The Grand Avenue solution suite meets your compliance needs, fits within your budget, and delivers clear and timely business value.

  • 100% web-based – All configuration, setup, and user features are delivered via web browser over the Internet. The user interface dynamically adapts to your device – from smart phones to tablets to laptops to large displays.
  • Compliance Features – The Grand Avenue product suite is aligned with ISO 13485:2016, 21 CFR/Part 820 – QSR, and EU 2017/745 – MDR.
  • Electronic signatures, Electronic Records – Grand Avenue was designed from the beginning to address the requirements of 21 CFR Part 11 for electronic records and electronic signatures.
  • Process Driven – Process-specific workflows based on industry best practices notify users of new tasks to be completed and upcoming deadlines for existing work.
  • Streamlined validation – The validation packet available for no additional cost with each software release serves as the foundation for your computer software assurance (CSA) efforts – reducing the cost, effort, and time to set up and maintain a compliant system.
  • Process Metrics – Visual indicators on configurable charts provide status for quality system processes.
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