Organizations use MasterControl Audit Essentials to manage their entire audit process from beginning to end...
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MasterControl’s patented Validation Excellence Tool (VxT) is our answer to risk- based validation. We worked with former FDA officials and industry experts to develop the tool, which lets you leverage
Connect training to other quality processes and automate the routing, tracking, and follow-up of training tasks and even the grading of online exams.
The MasterControl CQMS manages all documents, tasks, processes, relationships, audits and training that must be administered and controlled throughout the clinical trial lifecycle.
Corrective and preventive action (CAPA) is the single-most critical element of any quality system, and must be managed as such to satisfy both FDA and ISO requirements.
Bridges the traditional gaps that paper-based or disparate processes create between quality and manufacturing to drive immediate performance improvements and operational efficiencies.
ICH Q10 is a guideline that describes a model approach for a modern pharmaceutical quality system.
MasterControl Supplier™ provides a single repository for maintaining all supplier quality data and documentation.
"How-to" information for medical device companies complying with regulations standardized by the MDDs (Medical Device Directives). Access the MEDDEV-5 when developing quality and compliance processes.
Examine the FDA's Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations and how MasterControl software can help modernize your quality system.
Our customers are highly regulated companies whose goal is to create lifechanging products used by millions of people worldwide. Quality is critical to ensuring product safety and compliance.
As practiced by many regulated companies today, software validation is the single most expensive and time-consuming aspect of automating or upgrading their quality management and compliance systems.