Manufacturing GMP

cGMP Regulations

cGMP Regulations (Current Good Manufacturing Practices)

MasterControl Inc. is a GxP process management software provider that helps regulated companies attain and sustain compliance with good manufacturing practice (GMP) regulations.

GMP regulations are set forth to ensure the quality and safety of life science products. However, in the globalizing market of today, the pressure to produce products at a higher rate of efficiency and at a lower cost, challenge many regulated companies. MasterControl Inc. is a GxP process management software provider that helps regulated companies attain and sustain compliance with good manufacturing practice regulations.

FDA's current good manufacturing practice regulations ensure that products are consistently produced in a controlled environment with quality standards guiding their intended use. For over a decade, MasterControl has led the quality management software industry providing the products, training, and support companies need to sustain compliance.

GAMP®5: A Risk-based Approach to Compliant GxP Computerized Systems

GxP Process Management Software - Helping Companies to Comply with GMP Regulations

Sustain Compliance with Good Manufacturing Practice Regulations. MasterControl GxP process management software is time-tested and fully supported, offering regulated companies the solutions they need to attain and sustain regulatory compliance with good manufacturing practice regulation. The GxP process management software solution, MasterControl suite, includes a continuum of configurable, easy to use applications that specifically address the unique needs of FDA and ISO regulated companies. These applications include the following:

  • MasterControl Documents™

  • MasterControl CAPA™

  • MasterControl Training™

  • MasterControl Forms™

  • MasterControl Change Control™

  • MasterControl Audit™ According to GMP Regulations

  • MasterControl Customer Complaints™

  • MasterControl Nonconformance™

  • MasterControl Submissions Gateway

Risk management software on machinery

Implementation and Validation Software Services According to Good Manufacturing Practice Regulations

There is more to deploying GxP process management software than simply investing in it. FDA regulated companies must also follow GMP regulations when they implement and validate their software. With years of experience in the rigorous FDA and ISO environements, MasterControl has developed time-tested implementation and validation methods to help companies deploy softer sooner and receive software ROI faster.

Implementation Services: MasterControl works with their customers' IT Department to effectively and efficiently create, install, and configure software database.

Software Validation Services: MasterControl offers a continuous validation approach compliant with that dramatically cuts the time, pain, and cost involved in good manufacturing practice regulation validation with MasterControl Transfer OQ and MasterControl Automated OQ.

Two office workers discussion by laptop

For More Information on GMP Regulations

Good manufacturing practice regulations guide the way natural science companies conduct business. From employee training management to CAPA process management, MasterControl software solutions help companies effectively manage their document and quality processes. With MasterControl's Resource Center, regulated companies can find the educational and research materials they need to make the right decisions about compliance management. The Resource Center includes industry white papers about GMP regulation, industry current events, and GxP process management software solutions.

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