Enzyme provides an electronic Quality Management System (eQMS) designed for life sciences companies to streamline FDA approval and regulatory compliance processes. The software is flexible and scalable, enabling organizations to manage quality and compliance from premarket to postmarket stages efficiently.
Funding
$2M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
SCFounders
Product
Problem
Life sciences companies face significant challenges in maintaining quality and achieving regulatory compliance, particularly with FDA 21 CFR Part 11 requirements. Traditional quality management systems often rely on manual processes and disparate systems, leading to inefficiencies, errors, and difficulties in tracking and managing documentation across the product lifecycle. This complexity can hinder innovation, delay product launches, and increase the risk of non-compliance.
Solution
Enzyme provides a cloud-based electronic Quality Management System (eQMS) designed to streamline quality processes and ensure regulatory compliance for life sciences companies. The platform offers a centralized, validated environment for managing documentation, change control, training, design control, risk management, supplier management, audits, complaints, nonconformances, and corrective/preventive actions (CAPA). Enzyme eQMS integrates with existing tools, allowing users to import data and generate reports directly from the system. By automating workflows and providing real-time visibility into quality data, Enzyme helps organizations improve efficiency, reduce errors, and accelerate time to market while maintaining full compliance with industry regulations.
Target Audience
Enzyme's primary customers are medical device, digital health, and biopharmaceutical companies, ranging from startups to enterprises, that require a robust and compliant quality management system.
Features
- Document control with versioning, approval workflows, and electronic signatures to meet 21 CFR Part 11 requirements
- Automated change control management with impact assessment and audit trails
- Training management with role-based access control and competency tracking
- Design control features to manage product development from concept to launch
- Risk management tools for hazard analysis, FMEA, and risk mitigation
- Supplier management module for evaluating and monitoring supplier performance
- Audit management with scheduling, checklists, and findings tracking
- Complaint management system for capturing, investigating, and resolving customer complaints
- Nonconformance management for identifying, documenting, and resolving deviations from specifications
- CAPA management to investigate root causes, implement corrective actions, and prevent recurrence
- Microsoft Office 365 integration, allowing users to edit Word, Excel, and PowerPoint files directly within the Enzyme platform
- Pre-validated and 21 CFR Part 11 compliant out-of-the-box