Intellect QMS Product Overview
Intellect QMS (Quality Management System) is a comprehensive software solution designed to help organizations, particularly in the pharmaceuticals, healthcare, and manufacturing industries, meet stringent regulatory compliance requirements such as those set by the FDA, ISO, and other global GxP standards.
Key Functionality
- Regulatory Compliance: Intellect QMS ensures that organizations adhere to various regulatory standards, including FDA, ISO, and other global GxP regulations. It provides features such as 21 CFR Part 11 electronic signatures and virtual auditing to maintain compliance.
- Document Control: The system centralizes document management, tracking versions, revisions, and approvals in a single database. This ensures that teams have access to only approved and up-to-date quality documents, data, and reports anytime, on any device.
- Change Management: Intellect QMS includes robust change management capabilities, allowing organizations to automate workflows, track product changes, and ensure that all changes are documented and approved. It provides real-time notifications and visibility into change requests at any point in the production process.
- Automation and Efficiency: The software automates repetitive tasks such as routing, signing, and archiving of documents, complaints, Non-Conformance Reports (NCRs), and Corrective and Preventive Actions (CAPAs). This reduces manual errors, cycle times, and enhances overall operational efficiency.
- No-Code Platform: Intellect QMS is built on a no-code platform, enabling users to create and configure applications without requiring specialized programming skills. This flexibility allows organizations to adapt the system quickly to meet their unique needs.
Key Features
- Audit Management: Conduct virtual audits and manage audit processes efficiently.
- Calibration and Maintenance: Manage calibration and maintenance activities to ensure equipment compliance.
- CAPA and Nonconformance: Handle CAPAs and nonconformances with automated workflows.
- Dashboards and Analytics: Utilize real-time reporting and analytics to make informed decisions.
- Employee Training: Manage employee training programs to ensure compliance and quality standards.
- Risk Management: Identify, assess, and mitigate risks within the organization.
- Supplier Management: Oversee supplier quality and compliance.
- Validation and Verification: Ensure that processes and systems are validated and verified.
- Mobile App: Access the system via a mobile app for on-the-go management.
Deployment and Support
Intellect QMS can be deployed both on-premise and in the cloud, offering flexibility based on the organization’s infrastructure preferences. The system is designed for mid-size to large enterprises and is particularly beneficial for those in highly regulated industries.
In summary, Intellect QMS is a powerful tool that streamlines quality management processes, enhances compliance, and improves operational efficiency through automation, real-time reporting, and a user-friendly no-code platform.