Our Services
Quality Management
Ensure excellence in your operations and products with our Quality Management service. Identify areas for improvement, streamline processes, and meet regulatory requirements.
Key Features of Our QMS
Implement a robust Quality Management System (QMS) to design, develop, and deliver high-quality products and services while ensuring compliance.
Document Management
Validate, approve, sign, and track SOPs, procedure trials, and other documents electronically, with secure electronic signatures and approvals.
Change Management
Streamline audits, corrective and preventive actions (CAPA), and change control processes to ensure efficient identification, investigation, and resolution of quality issues.
Training and Compliance Management
Assign, track, and verify training requirements for employees to ensure compliance with regulations and standards to maintain a competent and qualified workforce.
Electronic QMS Dashboard and Analytics
Provide real-time visibility into quality performance with customizable dashboards, analytics, and reporting.
Why Choose Our QMS solution
Our expert services help you ensure compliance with industry standards and regulations (ISO 13485), streamline change control, and drive continuous improvement.
- Expertise
- Compliance
- Continuous Improvement
- Efficiency
Frequently Asked Questions
FAQs about our Quality Management Services
A QMS is a formal system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps you meet customer and regulatory requirements, reduce errors and costs, and improve overall performance. Additionally, if you manufacture medical devices, a QMS is a requirement to meet FDA regulations, ensuring compliance and patient safety.
We partner with Solabs to deliver comprehensive EQMS services, ensuring compliance with ISO 13485 standards. Our services include an electronic QMS dashboard for real-time visibility, document control for centralized management, change management, and training management for ongoing compliance. Our QMS service helps medical device manufacturers meet FDA requirements for audit trails to reduce the risk of regulatory issues.
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