Quality by Design (QbD)

Improve Your Quality, Efficiency and Agility With Quality by Design

Quality by Design (QbD) is a systematic approach to ensuring consistent quality in your products from the earliest design stages through production. For regulated and ISO companies, attaining high product quality is a business-critical endeavor, as insufficient quality can lead to costly consequences such as rework, warranty claims, noncompliance, recalls and lost customer loyalty. MasterControl can help your company implement QbD so that you can:

  • Plan and build quality into all stages of the design and manufacturing process
  • Get your products' critical characteristics to operate on target with minimal variation
  • Troubleshoot and identify the root causes of quality issues quickly and precisely, reducing production downtime
  • Facilitate continuous improvement of your operating procedures from start to finish
  • Reduce the likelihood of receiving an FDA inspection, and minimize the time to complete inspections when they do occur by having the data you need to answer questions
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Implement QbD With the Help of MasterControl's Industry-Leading Expertise

Traditional product development and production rely on inspection and testing of finished products to determine their quality. In this type of environment, manufacturing processes tend to be inflexible in an attempt to keep them reproducible, while the variability in materials and other inputs is rarely accounted for. It is an approach that merely observes and documents quality, offering little opportunity to efficiently improve it.

QbD, on the other hand, is a proactive approach to product development which involves risk management and continuous improvement. By identifying the parameters that impact the variability of a product’s critical characteristics (e.g., chemical composition, weight, flexibility, heat tolerance, cost, etc.) and implementing methods to isolate, monitor, control and document these parameters, QbD allows you to achieve end products that consistently hit their target levels of quality, safety and efficacy with minimal variation. With your processes so carefully dialed in, you can systematically identify the source of any issue or deviation and resolve it quickly, saving your company valuable time and money.

MasterControl's consultants and product managers have decades of combined experience in regulated and ISO industries. They understand the principles of QbD and offer their expertise and consulting to companies like yours that want to increase efficiencies in their design, development and production processes.

MasterControl's QbD experts can help you:

  • Minimize the risk of unexpected costs and production delays, expediting your time to market
  • Develop a better understanding of your processes - their strengths and potential weaknesses, and known sources of variability
  • Identify and control the production parameters that influence your products' critical characteristics
  • Employ a systematic, data-driven approach to identifying the root causes of quality issues, deviations and out of specifications (OOS) instead of relying on trial and error
  • Align with the FDA's recommendations and avoid deficiency letters citing the lack of QbD

Streamline Your QbD Processes With MasterControl's Integrated Software Solutions

MasterControl's integrated enterprise quality management software (EQMS) solutions fully support QbD in your design and production processes. With solutions like MasterControl Documents, Change Control and CAPA, you can:

  • Manage a product's information throughout its entire lifecycle using a centralized web-based repository which can be accessed any time by any authorized user, making search and retrieval easy during inspections
  • Automate and connect enterprisewide processes such as document control, change control, CAPA, nonconformances, training management, customer complaints and audit
  • Enhance your risk management process by adding essential capabilities, including electronic workflows, risk assessment forms, and analytics and reporting tools, which can all be integrated with your other quality processes

Learn More About How to Implement QbD

For more information about how MasterControl can help you implement QbD in your processes or to learn about MasterControl's line of integrated EQMS solutions, please contact a MasterControl representative.