Solution Overview

Proven validated quality compliance software solutions for life science companies.

Modular, Configurable, Scalable, Easy-to-Use

Grand Avenue Software is a flexible suite of out-of-the-box quality management and compliance solutions for medical products companies. The solutions are delivered through a unique combination of web-based processes and proven best practices, each completely validated to assure compliance.

Assured Compliance

Easy to Use

Low Cost of Ownership

Saving Time & Money

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.

Solution Building Blocks

Compliance Functionality

Grand Avenue’s out-of-the-box features, forms, and workflows incorporate proven best practices to deliver needed functionality for compliance.

Service and Support

Grand Avenue’s best-in-class software support combined with an extensive implementation partner network ensures your deployment success.

Advanced Technology

Grand Avenue’s web-based solution leverages state-of-the-art user interface and data center advancements to provide a reliable, always available, and secure solution.

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.


Frequently Asked Questions

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Is my organization’s data and information safe in the cloud?

Yes, Grand Avenue Software provides strong security measures like encryption, access control, and audit trails, ensuring data protection and compliance with industry standards such as ISO 13485 and FDA 21 CFR Part 11​. We’re partnered with a multi-site data center that has ISO 27001 certification along with a backup policy that performs hourly transaction log backups, daily differential backups and a bi-weekly full backup. You can also view the status of your backups at any given time.

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How does Grand Avenue Software help my company achieve regulatory compliance?

Grand Avenue ensures regulatory compliance by providing tools for document control, Complaint Handling, CAPA management (SCARs), Supplier Management, Nonconforming Material Reports, Training Management (assessments are available within the module), and Audit readiness. The software aligns with standards like ISO 13485 and 21 CFR Part 11, offering features such as electronic signatures, audit trails, and out-of-the-box compliant workflows​.

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How do I migrate my existing QMS docs and processes into Grand Avenue Software?

Migrating your existing QMS documents and processes into Grand Avenue Software is a streamlined process involving several key steps. First, assess and clean up your existing data to determine what will be transferred. Next, update your QMS procedures to align to Grand Avenue’s module workflows. Then, use the platform’s bulk upload feature to import documents and configure workflows to automate your operations. Finally, validate the system to ensure compliance, and provide training for your team to ensure a smooth transition, or ask Grand Avenue about their full service implementation option.

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Can my medical device company use Grand Avenue Software if we are internationally based or intend to sell our devices into international markets?

Yes, Grand Avenue Software can be used by internationally based medical device companies or those intending to sell devices in international markets. The platform supports compliance with global regulatory standards, including ISO 13485 and the EU Medical Device Regulation (MDR), as well as FDA 21 CFR Part 11 for U.S. markets. Its flexible, modular design allows it to adapt to different regulatory requirements across various regions, making it ideal for companies operating globally. Additionally, its cloud-based architecture allows easy access from any location, supporting international operations.

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How long does onboarding take?

Onboarding for Grand Avenue Software typically takes 4 to 8 weeks, depending on the complexity of your organization’s needs and the modules being implemented. This timeframe includes steps such as:

1. Initial setup and configuration

2. Data migration

3. Process customization

4. Employee training

5. Testing and validation

Grand Avenue’s support team works closely with your organization to ensure a smooth transition and successful implementation. However, the timeline can be adjusted based on your company’s specific requirements and readiness.

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How is the software licensed? Can I install it on my own server?

Grand Avenue Software is primarily a cloud-based SaaS platform, offered via a subscription model based on the features and number of users you need. It’s hosted on secure cloud servers, and all maintenance and updates are managed by Grand Avenue.

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Do you offer onboarding services?

Grand Avenue Software offers onboarding services that include setup, data migration, training, and customization. Reach out to us to discuss your needs, time-frame and our cost-effect solutions.

Grand Avenue is your solution for quality compliance

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