If your company belongs to a regulated industry, it is likely that you are familiar with the term "GxP," which refers to "Good Practice" regulations and guidelines. Perhaps your company has already established a GxP system, or is in the process of creating one and looking for the appropriate GxP software.
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The "x" in GxP is a variable that stands for manufacturing, clinical, laboratory, or clinical laboratory. GxP generally refers to GMP, GLP, and GCP regulations and guidelines established by the U.S. Food and Drug Administration (FDA). There are also similar ISO, ICH, and EU directives and principles. The World Health Organization (WHO) has developed GCLP guidelines. GxP software solutions available in the market today are based on those regulations and standards. Many regulated companies utilize a GxP system, which typically consists of various processes designed for the purpose of GxP compliance.
The FDA enforces GMP regulations for the pharmaceutical industry (21 CFR 211) and medical device industry (21 CFR 820, also known as Quality System Regulation). The concept of GMP is also incorporated in the FDA's "GMP Guidelines and Inspections Checklist," based on the Federal Food, Drug, and Cosmetic Act. Most GxP software solutions address these regulations.
The GMPs for pharmaceutical and medical device companies are applicable to the entire process of development and manufacture of products including design, manufacture, packaging, and labeling. If your company is evaluating GxP software solutions, be sure to look for a solution that addresses these different processes.
Many manufacturers seek ISO certification to position their products and services in the global market more competitively. Just like the FDA's GMP regulations, the overall goal of the ISO 9000 series for general manufacturers and ISO 13485 for medical device companies is to ensure safe and high-quality products and services. Manufacturers are increasingly relying on GxP software when they establish a quality system for the purpose of both FDA and ISO compliance.
The FDA has harmonized QSR with ISO standards, making them complementary. In looking for GxP system, companies should make sure that the solution they choose addresses both GMP and ISO standards.
Manufacturers usually establish a GxP system with GCP requirements in mind, either by utilizing software or a traditional, paper-based system. When manufacturers create a GxP system, it is likely that they are addressing the requirements of any or all of the following GCP regulations and standards for conducting clinical trials:
MasterControl GxP software solutions address GMP, GCP, GCLP, GLP, and CLIA requirements, making it an ideal foundation for any GxP system. MasterControl offers the following solutions:
To learn more about MasterControl GxP software systems, please feel free to contact a MasterControl representative.