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:
|Download Free Resources|
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:
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:
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.