Enzyme eQMS

Enzyme provides a flexible and scalable Electronic Quality Management System (eQMS) tailored specifically for the life sciences sector, including medical devices, digital health, and biopharma companies. The platform supports the entire product lifecycle, from premarket to postmarket, making it suitable for both startups and large enterprises. Users have reported significant improvements in their quality processes and compliance following its adoption.
The Enzyme eQMS includes essential features such as:
- Document Control: An intuitive document management experience allows users to draft, review, approve, and archive documents without being restricted by proprietary formats. The system supports integration with popular drafting tools, automated document management, version control, and compliance with industry regulations.
- CAPA (Corrective and Preventive Actions): This module helps organizations manage quality issues effectively, addressing complaints and nonconformances through a structured four-phase process. The CAPA module allows task assignment, deadline tracking, and workflow adaptability, facilitating continuous improvement and adherence to compliance standards.
- Change Control: This feature ensures that all changes are documented, reviewed, and approved systematically to maintain compliance and quality.
- Risk Management: It supports users in identifying, assessing, and controlling risks throughout the product lifecycle.
Enzyme's QMS is designed to integrate seamlessly with existing tools, enhancing overall efficiency without disrupting established workflows. Feedback from users indicates that the platform's ease of use, combined with professional support, fosters a smoother transition from traditional paper-based processes to digital solutions.