Quality
Out of Specification (OOS)
Interconnected OOS software lets you comply with U.S. Food and Drug Administration (FDA) regulations and ISO standards. Current good manufacturing practices (CGMPs) require regulated manufacturers to follow specifications that define parameters for a product. When a product is OOS, a company must investigate and document the results.
An OOS doesn’t happen in a vacuum. So, we connect it to all your quality processes.
Corrective Action Preventive Action (CAPA)
Audit Management
Document Control
Trusted By
Correct an OOS During Manufacturing
Part of the tension between quality and manufacturing comes from quality events, such as OOS. In-line quality event management eases this tension. With a solution like MasterControl Manufacturing Excellence, an out of specification during the manufacturing process can be fixed without slowing down the process.
The Perks of a Platform
Quality and manufacturing are only two parts of the product life cycle. There's also product development, clinical, regulatory, supplier, and postmarket. A platform approach interconnects all processes and stores data and documentation on the same cloud-based system.
