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Enzyme QMS
VS
QEdge eQMS
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.
QEdge eQMS
QEdge eQMS is an industry-ready, GxP-compliant enterprise quality management system tailored for the pharmaceutical and life sciences industries. This platform centralizes essential quality processes, such as change control, deviation, investigation, CAPA, market complaint management, and vendor qualification on a single, configurable dashboard. The system provides seamless integration with ERP, LIMS, and MES solutions, optimizing organizational workflows while supporting regulatory compliance and robust audit trails.
Backed by over 25 years of domain expertise, QEdge eQMS leverages advanced technology including generative AI for analytics, customizable data-driven dashboards, and automated document management. Its features enable efficient handling of documentation, streamlined audit management, effective training scheduling, automated PQR/APQR generation, and cloud readiness to enhance operational efficiency and regulatory adherence for life science enterprises.
Pricing
Enzyme QMS Pricing
Enzyme QMS offers Contact for Pricing pricing .
QEdge eQMS Pricing
QEdge eQMS offers Contact for Pricing pricing .
Features
Enzyme QMS
- 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.
QEdge eQMS
- Configurable Workflows: Adaptable modules to fit various business scenarios and regulatory needs
- Automated Document Management: Centralized control of manuals, SOPs, BMRs, and work instructions
- AI-Enabled Analytics: Advanced data analysis and reporting powered by generative AI
- Comprehensive Training Management: Auto-scheduling, certification, and compliance tracking
- Vendor Qualification: Streamlined communication and approval management with vendors
- Process Control: Unified change control, CAPA, deviation, investigation, and risk assessment
- Audit Management: Detailed audit trails and compliance support for regulatory inspections
- Seamless Systems Integration: Compatible with ERP, LIMS, and MES platforms
- User-Driven Dashboards: Customizable and interactive reporting features
- Cloud-Ready Solution: Secure, scalable cloud infrastructure ensuring availability and security
Use Cases
Enzyme QMS 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.
QEdge eQMS Use Cases
- Automating quality event management for pharmaceutical manufacturing
- Centralizing compliance documentation and issuance
- Scheduling and tracking workforce training and certifications
- Managing change control and deviation workflows for life science operations
- Generating regulatory-compliant product quality review reports
- Facilitating vendor qualification and document exchanges
- Conducting risk assessments and audit management with robust traceability
Uptime Monitor
Uptime Monitor
Average Uptime
100%
Average Response Time
131.47 ms
Last 30 Days
Uptime Monitor
Average Uptime
99.56%
Average Response Time
1536.8 ms
Last 30 Days
Enzyme QMS
QEdge eQMS
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