Quality Management
End-to-End Digital Quality Management
Drive Data-Centric Quality Excellence in Biopharma
Quality is essential for patient safety, treatment efficacy, sustainability and protection of brand reputation. Dassault Systèmes helps organizations achieve Quality and Business Excellence with a new and comprehensive data-centric approach to Quality that supports patient safety, treatment efficacy, sustainability and protection of brand reputation—all based on digital continuity, data integrity and a “Single Source of Truth.” Integrated capabilities include Quality Document and Content Management including automated tasks, electronic signatures, standardized processes, audit trails and Quality Process Management (e.g., CAPA investigations or root-cause analysis).
The system provides immediate access to data and documents with hyperlinks and Quality Intelligence using machine learning and federated search. Developed for the highly regulated BioPharma industry, this cloud-based solution supports full regulatory compliance with a modern, intuitive user interface and is readily scalable from only a few to 100,000 users.
BIOVIA Quality Management Software Key Benefits
Saves Money
Minimizes mistakes, improves yield and ensures predictability in processes
Leverages Data
Ingests legacy customer data and present that equally with new quality processes that can be used for analytics and AI/ML
Streamline Processes
Uses both OOTB processes and customers own configurations – treated equally
3DEXPERIENCE on Cloud
Links to the line of business applications on 3DEXPERIENCE – connected digital quality
Preserves Workflow
Combines best practice processes, an industry standard workflow engine and analysis capabilities for end-to-end quality
A SaaS Cloud Solution
BIOVIA Quality Management is available on the 3DEXPERIENCE platform to help deliver the benefits of an analyst application that uses data to provide insights on similar issues and potential trends.
Key Benefits:
- A single application available to all key stakeholders
- Simplified access to all records with the ability to easily expand into insights to get details of impacted items, contributors, change history the full reports
- Simple "one click" to filter and sort "likely similar"
- Issues link through all processes making cause and effect easier to determine
Explore BIOVIA Quality Management Solutions Related to Your Professional Role
BIOVIA Quality Management solutions are packaged as Roles to get you up to speed faster and work more efficiently with all needed applications available at your fingertips. Select a package that corresponds to your role in an organization.
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The world of Quality Management is changing. Discover how to stay a step ahead with BIOVIA
FAQ About QMS in the Pharma Industry and ICH Q10 Quality Guidelines
A pharmaceutical quality management system (QMS) is a structured system of procedures and processes intended to ensure the production, control, and distribution of pharmaceutical products meet the required safety, efficacy, and quality standards. This system is critical in maintaining the integrity of drug production and compliance with regulatory requirements. Here are the key elements and functions of a pharmaceutical QMS:
- Quality Assurance (QA): This involves the overall management and guarantee that all pharmaceutical products are manufactured to meet the standards required for their intended use. QA includes developing, implementing, assessing, and continually improving processes.
- Quality Control (QC): QC deals specifically with the operational techniques and activities used to fulfill quality requirements, such as laboratory testing and product inspections.
- Documentation: Comprehensive documentation is essential to ensure compliance and traceability. This includes recording every aspect of the development and manufacturing process, as well as changes and investigations into deviations.
- Standard Operating Procedures (SOPs): These are detailed, written instructions to achieve uniformity in the performance of a specific function. SOPs are central to a robust QMS.
- Risk Management: Identifying, evaluating, and mitigating risks associated with pharmaceutical manufacturing to ensure product quality and compliance.
- Continuous Improvement: The QMS includes mechanisms for monitoring system performance and implementing improvements based on data-driven insights.
- Audits and Self-Inspections: Regular audits and inspections are conducted to ensure that the operational processes and SOPs are being followed and are effective.
- Regulatory Compliance: Compliance with local and international regulatory requirements is fundamental to a pharmaceutical QMS. This includes adhering to guidelines from agencies like the FDA (Food and Drug Administration) in the USA or the EMA (European Medicines Agency) in Europe.
Good Manufacturing Practice (GMP) is not a quality management system (QMS) in the traditional sense like ISO 9001; rather, it is a system for ensuring that products are consistently produced and controlled according to quality standards. GMP is specifically designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
The difference between Quality Management System (QMS) and Pharmaceutical Quality System (PQS) lies in their scope and application:
- Quality Management System (QMS):
- Scope: General, applicable across various industries.
- Purpose: Ensures compliance with customer requirements and regulatory standards.
- Components: Includes document control, internal audits, corrective actions, and continuous improvement.
- Pharmaceutical Quality System (PQS):
- Scope: Specific to the pharmaceutical industry.
- Purpose: Ensures quality, safety, and efficacy of pharmaceutical products.
- Components: Includes QMS elements plus Good Manufacturing Practices (GMP), risk management, and pharmaceutical regulatory compliance.
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