Product specification management is the discipline of managing all of the data needed to make a product and its related components, such as packaging, raw materials, formulations, ingredients. Over the past decade, managing product specifications has become increasingly important.
But, with its rise in importance also comes a rise in complexity. Product specification management in the biopharmaceutical industry is notoriously complex and demands meticulous attention to detail, as specifications impact every phase from R&D to regulatory approval.
The Challenges
The Solution
The Product Specification Management solution from Dassault Systèmes allows biopharma companies to manage specifications as structured data, making information more reusable and simplifying change management. With this solution, teams can collaboratively build and standardize specifications for each raw material in a secure, controlled platform. By reusing specifications across multiple products, it ensures consistency and accuracy in medicinal products. This dynamic, data-driven approach provides a single source of truth, enabling users to focus on higher-value work while maintaining high-quality, accurate, and consistent specifications.
The Benefits
25% Time reduction to develop
40% Regulatory compliance improvement
20% of time reduced to scale up and transition to manufacturing