SafeLink Consulting is pleased to announce its new strategic relationship with Grand Avenue Software, a leading provider of electronic quality management systems, or eQMS tools for organizations creating medical devices. This collaboration delivers Grand Avenue’s advanced eQMS software with SafeLink’s expertise to help companies manage quality FDA compliance.
Grand Avenue eQMS is scalable to the maturity and scope of a business' needs starting with the basics and adding modules when the business model changes.
SafeLink’s consulting and Grand Avenue’s software come together to deliver effective quality compliance that is automated, efficient, validated, and effective. This eQMS solution meets the dental FDA compliance needs, fits within budget, and delivers clear and timely business value. This software is fully web-based, eliminating the need to switch between Sharepoint or other platforms for document control. The Grand Avenue product suite is aligned with ISO 13485:2016, 21 CFR Part 820 and EU 2017/745-MDR. This is especially important since on 1.31.2024 FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard. This eQMS is also designed from the beginning to address the requirements of 21 CFR Part 11 for electronic records and electronic signatures.
The process-specific workflows are designed based on industry best practices to keep users informed about new tasks and upcoming deadlines. In addition, our validation package, which is included with each software release, serves as a solid foundation for your computer software assurance efforts. By reducing the cost, effort, and time required to set up and maintain a compliance system, it streamlines your processes. Furthermore, our process metrics offer visual indicators on customizable charts, providing you with real-time status updates for your quality system processes. With Grand Avenue Software, you can establish a robust compliance foundation that grows and adapts alongside your business, catering to the needs of multi-division and multi-national organizations. Read the full Press Release.
At SafeLink Consulting, we know how challenging the FDA process can be for a dental laboratory, dental device company or medical device manufacturer, which is why we are committed to helping our customers enhance their compliance processes, improve document control and maintain a quality culture. We are confident that our deep risk management expertise, combined with Grand Avenue Software’s quality management software and support, will help companies achieve compliance quickly, standardize processes, increase productivity, control overhead expense and ultimately increase profit.
Explore more about Grand Avenue eQMS.
Protect your assets by implementing a proven FDA/Quality System to ensure your business thrives. Ensuring that your management team has access to a knowledgeable resource on the regulations that apply to your organization will set your business apart from others. Our compliance advisors are ready to help you succeed through our dedicated service. Contact SafeLink Consulting to learn more about quality management systems and FDA compliance or safety and OSHA compliance.
Learn more about FDA Dental Regulations