Welcome to RapidFacto Documentation

RapidFacto is a comprehensive Quality Management System (QMS) designed specifically for medical device manufacturers. This documentation will help you understand and use all the features of the system.

What is RapidFacto?

RapidFacto helps medical device companies manage their entire quality and manufacturing process, from purchasing raw materials to delivering finished products, while maintaining compliance with regulatory requirements like 21 CFR Part 11.

System Overview

Getting Started

New to RapidFacto? The Getting Started section will guide you through the basics of using the system, including how to log in, navigate the interface, and understand your role and permissions.

Purchase

Manage your entire procurement process in one place. This section covers everything from finding and managing suppliers, creating requests for quotations (RFQ), placing purchase orders, receiving goods, and tracking payments to suppliers. Keep track of all your purchasing activities and maintain proper documentation for quality audits.

Production

Track and manage your manufacturing operations from start to finish. Create and manage product models, track production batches, monitor machine and equipment usage, and analyze production performance. This section helps you maintain complete traceability of your manufacturing process, which is essential for medical device compliance.

Maintenance & Calibration

Ensure your equipment and machinery are properly maintained and calibrated according to schedule. This section helps you schedule maintenance activities, track calibration records, and maintain a complete history of all maintenance work. Proper maintenance and calibration are critical for ensuring product quality and regulatory compliance.

QMS (Quality Management System)

The heart of RapidFacto's quality management capabilities. This section includes:

• Documents & Records: Manage all your quality documents, create records from templates, and maintain version control
• Approval Workflows: Set up and manage approval processes for documents and other quality records
• Training: Track employee training and certifications
• Internal Audits: Plan, conduct, and track internal quality audits
• CAPA: Manage Corrective and Preventive Actions to address quality issues
• MRM: Conduct Management Review Meetings and track action items
• Logbooks: Maintain various quality logbooks as required

All activities in the QMS section support 21 CFR Part 11 compliant electronic signatures, ensuring your quality records meet regulatory requirements.

Settings

Configure your account preferences, update your profile, and adjust system settings to match your workflow. Administrators can also manage user permissions and system-wide configurations from this section.

Getting Help

If you need assistance with any feature, refer to the specific section in this documentation. Each section contains detailed guides and tutorials to help you use RapidFacto effectively.