Simploud is a cloud-native compliance platform tailored for life sciences and medtech companies, integrating Quality Management System (QMS), Laboratory Information Management System (LIMS), and Design Control into a unified ecosystem. Built on Salesforce, it offers a subscription-based model that includes design, configuration, validation, training, support, and upgrades without hidden costs. This ensures businesses can maintain compliance with regulations such as 21 CFR Part 11 and Annex 11 while optimizing operational efficiency.
Key Features and Functionality:
- Quality Management: Provides a customizable eQMS platform that adapts to unique company needs, facilitating document control, audits, risk management, and corrective actions.
- Laboratory Management: Offers a LIMS solution that revolutionizes lab operations by combining lab and quality activities in a single platform, ensuring comprehensive and easy-to-implement lab management.
- Design Control: Manages the entire design process from input to output, review, verification, and validation, simplifying complex processes for medical device management.
- Electronic Notebook (EN): A robust, flexible, and user-friendly solution for managing data, coordinating workflows, and facilitating collaborative projects, extending beyond the lab to various functions within life science companies.
- Manufacturing Operations: Enables management of materials, batch manufacturing processes, and maintenance of audit-ready Device History Records (DHRs) within a unified, cloud-based platform.
Primary Value and Solutions for Users:
Simploud addresses the critical need for efficient compliance and quality management in highly regulated industries. By unifying QMS, LIMS, and Design Control, it eliminates the complexities associated with managing multiple disparate systems. The platform's flexibility allows businesses to tailor processes to their specific requirements without incurring additional costs or extended implementation times. This results in streamlined operations, reduced manual efforts, and enhanced regulatory adherence, ultimately driving efficiency and ensuring audit readiness.