QMS Lite

A streamlined, digital Quality Management System designed to help pharmaceutical, life sciences, and early‑stage medtech companies rapidly establish a compliant, efficient, and user‑friendly quality framework, aligned with ISO 13485:2016 principles and the FDA’s new QMSR where relevant.

Experience a foundational QMS setup tailored to your organization’s specific needs, combining essential documentation templates with basic training to ensure smooth implementation and effective user adoption—all delivered through a modern, cloud-based platform.

Key Features:

Digital QMS Setup
Implement a structured, electronic QMS platform that centralizes your quality processes, documentation, and responsibilities in one accessible system. Our QMS Lite supports compliance with critical pharmaceutical and life sciences standards including ISO 9001, FDA 21 CFR Parts 210/211, ICH Q10, and EU GMP, and can be extended to reflect ISO 13485:2016 and the FDA’s QMSR expectations for medtech teams.

Ready-to-Use Templates
Access a comprehensive suite of standardized templates covering core QMS documentation: quality manuals, SOPs, work instructions, training records, deviation and CAPA forms, change control, and audit management. These templates provide a consistent and controlled foundation for your quality operations.

Basic Training
Equip your team with introductory training on QMS principles, system navigation, and best practices for document control, change management, and compliance monitoring. This ensures your staff understands their roles within the QMS and can confidently use the digital tools provided.

Efficient and Scalable
Ideal for organizations seeking a fast, cost-effective way to build a compliant QMS foundation, QMS Lite scales with your company’s growth and evolving quality needs.

Supplier & Process Quality Management (optional add‑on)

Supplier Qualification and Audits
We set up and execute supplier qualification and monitoring processes in line with ISO 13485 §7.4, including supplier audits, quality agreements, and incoming inspection strategies for critical materials and services.

Risk Management per EN ISO 14971:2019
We design and maintain risk management files aligned with EN ISO 14971:2019 and MDR expectations, covering hazard identification, benefit‑risk evaluation, and risk control measures across the product lifecycle.

Process Validation and Ongoing Control
We plan and document manufacturing process validation in accordance with ISO 13485 §7.5.6 and help implement ongoing controls such as sampling plans and basic statistical process monitoring to keep processes capable and inspection‑ready.

Partner with us to implement a modern, digital quality management system that accelerates compliance, empowers your team, and supports your regulatory success—without complexity or delay.