QbDVision is a cloud-based software platform designed to streamline quality management and product development in regulated industries such as pharmaceuticals, biotechnology, and medical devices. The platform focuses on the principles of Quality by Design (QbD), which integrates quality assurance into the early stages of product development to ensure that products meet regulatory requirements and maintain high standards throughout their lifecycle. QbDVision offers tools for risk management, design control, and data analysis, helping companies accelerate development while ensuring compliance.

Key Features:

1. Quality by Design (QbD) Framework: QbDVision is built around the QbD framework, allowing teams to integrate quality assurance into product design and development from the very beginning.

2. Risk Management: Provides risk assessment and management tools to identify potential product risks, assess their impact, and implement mitigation strategies, ensuring compliance with regulatory guidelines like FDA and EMA.

3. Design Control: Enables structured and compliant product development processes by integrating design controls into the product lifecycle, ensuring that products meet all regulatory requirements.

4. Real-Time Collaboration: QbDVision offers collaborative tools that allow cross-functional teams to work together in real-time, sharing data, insights, and progress throughout the product development cycle.

5. Data Analytics and Visualization: The platform includes powerful analytics tools that help organizations visualize and analyze data related to product quality, allowing for better decision-making and continuous improvement.

6. Document Control: QbDVision provides centralized document management, ensuring that all quality documents, such as protocols, risk assessments, and design history files, are securely stored and easily accessible.

7. Regulatory Compliance: QbDVision helps companies maintain compliance with industry regulations, including FDA and ISO standards, by providing structured workflows and audit trails for product design and development.

Why Companies Choose QbDVision:

• Streamlined Quality Management: QbDVision integrates quality assurance into every step of product development, ensuring that products meet regulatory requirements and quality standards from the outset.

• Risk Mitigation: By integrating risk management tools, QbDVision helps companies proactively identify and address potential issues, reducing the likelihood of product recalls or regulatory setbacks.

• Improved Collaboration: QbDVision fosters real-time collaboration between product development teams, ensuring that all stakeholders have access to the latest data and insights, improving efficiency and decision-making.

• Regulatory Compliance: The platform helps companies meet the stringent regulatory requirements of industries like pharmaceuticals and medical devices, providing the necessary tools for audit trails, documentation, and design controls.

How AiDOOS Can Support QbDVision Implementation:

Implementing QbDVision effectively requires customization to align with specific quality management workflows and regulatory requirements. AiDOOS provides on-demand talent to:

• Integrate QbDVision with existing product lifecycle management (PLM) and quality management systems (QMS), ensuring smooth data exchange and workflow integration.

• Customize QbDVision’s risk management and design control features to fit the unique requirements of pharmaceutical, biotech, and medical device companies.

• Provide training and support to ensure teams can fully leverage QbDVision’s quality management tools, enhancing collaboration and compliance efforts.

• Offer ongoing technical support to optimize platform performance, ensuring QbDVision continues to support evolving quality management processes and regulatory needs.