FDA Quality

Compliance to FDA Quality Standards is an Essential Requirement that Can Easily Be Met by the MasterControl Quality Management System

FDA quality standard guidelines focus on implementing the latest quality management systems and risk management approaches. Because of this, companies are incorporating innovative manufacturing technologies and methods in their existing quality systems. The MasterControl suite of applications adheres with FDA regulations so that the risk of fatal violations and calamitous fines is eliminated.

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How to Successfully Complete an FDA Inspection

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Hundreds of companies around the world use MasterControl to automate core business processes and document management activities to promote collaboration, improve decision making, and accelerate time to market.

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Free Resources on FDA Quality Compliance

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Industry Brief: 8 Best Practices for Compliant and Quick Software Validation in the Cloud
White Paper: How to Successfully Complete an FDA Inspection White Paper: FDA Inspections of Clinical Investigators: Are You Ready? White Paper: Most Common Reasons for FDA Form 483 Observations and Warning Letters in Medical Device Environments
e-book: FDA and ISO Compliance for Pharmaceutical Manufacturers e-book: FDA and ISO Compliance for Medical Device Manufacturers

MasterControl and FDA Quality Standards

FDA approval is considered to be the final word in manufacturing products designed for human use which is why companies across the globe are incorporating quality systems that are consistent with FDA regulations. The MasterControl quality management system suite of applications provides companies with the essential features that help in achieving and sustaining FDA compliance.

The main emphasis of FDA quality standards is to educate companies in inventing consistent means or embracing proven methods for incorporating quality in products from the very start of the product development lifecycle. An efficient quality system addresses the needs of various stakeholders which is why MasterControl provides companies with a web-based repository that is accessible to authorized users from virtually anywhere. The online platform serves as a consolidated portal for collaboration on new ideas and standard practices. Users are able to discuss and finalize plans for enforcing quality in products from the start of the development phase.

FDA quality standards emphasize the implementation of a quality management system (QMS) that is customizable to fit into any company's framework and methodology. MasterControl allows companies to build a QMS that can be tailored to meet any business requirements, taking into account several factors such as the scope of business operations, complexity of processes, and allocation of resources. This allows companies to align their quality processes with their business model and develop products that are FDA compliant. With quality procedures in sync with the overall business operations, it is inevitable that quality management principles will converge across different departments, sectors, branches, and regions.

Meeting FDA Quality Standards with MasterControl

The holistic approach to quality management provided by the MasterControl software solution suite creates a seamlessly integrated quality system that allows companies to easily attain FDA compliance. Moreover, adherence with FDA quality standards also assures that the company is also able to comply with CGMP and ISO standards. Our software ensures that a well built quality management system is implemented that can ultimately reduce the number of rework and recalls for defective or out-of-specification products while also upholding the company's reputation in the marketplace.

While heavily regulated companies rely on many employees to achieve FDA quality compliance, it is upper management that is primarily responsible for quality and compliance breaches. To avoid the dreaded FDA 483 statement, the MasterControl suite of applications ensures that the quality system requirements are successfully established and maintained.

Effective internal quality standards in conjunction with a proven and reliable QMS solution help companies avoid non-compliance to FDA quality standards that lead to irrevocable consequences such as fines ranging in the millions of dollars or lost manufacturing licenses. To avoid such issues, upper management needs to establish quality and compliance safeguards by following the established quality management plan and regularly communicating with quality management representatives. In addition, the quality team must properly review and document the quality maintained during production. Any issues pointed out during reviews must be dealt with immediately with solutions being reflected in an updated quality policy. MasterControl cements and simplifies these policies and procedures through use of technology enablers that enforce FDA quality efforts. By solidifying a company's standard quality practices with FDA quality measures MasterControl helps companies maintain compliance in their business while getting products to market quickly and inexpensively.

For More Information on the FDA Quality

The MasterControl team is here to answer your questions and get your company's products on the right track toward FDA quality process. Call 800-825-9117 to speak with a MasterControl team member or contact MasterControl for more information.