What is Enzyme QMS?
Enzyme QMS is a comprehensive electronic Quality Management System (eQMS) designed to support the full product lifecycle for medical device, digital health, and biopharma companies. This software is 21 CFR Part 11 compliant and validated out-of-box, ensuring regulatory adherence.
Enzyme QMS offers an industry-leading number of integrations, allowing seamless incorporation into existing workflows. The system is built to adapt and scale with growing businesses, providing a flexible and versatile QMS solution from premarket stages to postmarket compliance and beyond.
Features
- Document Control: Manage and control documents.
- Change Control: Track and manage changes.
- Training: Manage employee training records and requirements.
- Design Control: Supports design control processes.
- Risk Management: Integrated risk management tools.
- Suppliers: Manage supplier information and quality.
- Audits: Facilitate and manage audits.
- Complaints: Handle and track complaints.
- Nonconformance: Manage nonconformance issues.
- CAPA: Corrective and Preventive Actions management.
- eSignatures: Electronic signature capabilities.
- Integrations: Integrates with popular business applications.
Use Cases
- Streamlining quality processes in medical device companies.
- Managing post-market compliance in digital health.
- Ensuring 21 CFR Part 11 compliance in biopharma.
- Facilitating audits for regulatory compliance.
- Managing risk throughout the product lifecycle.
- Centralizing document control for improved organization.
