The concept of quality goes hand and hand with consumer safety. In the United States, Congress passed the Pure Food and Drug Act in 1906, which made it (for the first time) illegal to sell contaminated food and also required truthful labeling on drugs. It was the beginning of government oversight over the food and drug industries. Subsequent regulations required manufacturers to establish a quality management system (QMS system) to ensure product quality and safety. The QMS software in the market today is based on the same belief that quality is essential to consumer safety.
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Over the years consumer safety problems served as a catalyst for change in industry regulation. For example, 107 people in the United States died in 1937 due to the antibacterial drug Elixir Sulfanilamide, forcing authorities worldwide to establish Good Manufacturing Practice (GMP) standards. QMS systems using QMS software are designed to implement GMP standards.
In the U.S., the Food and Drug Administration (FDA) enforces regulations for pharmaceutical, medical device, blood and biologics, and other regulated industries. The agency also provides guidances that offer a framework for establishing QMS systems.
In other parts of the world, there are similar regulations and standards that are driving the increasing use of QMS software. They include MHRA, EMA, and MHLW rules; EU Annex 11 and ICH guidelines; and ISO and EU GMP standards.
Of all the regulations that the FDA enforces, the two below are among the most important and the most widely applied worldwide. QMS software for life science companies are designed based on requirements that can be found in these regulations:
In addition to regulations that the FDA enforces, the agency encourages manufacturers to adhere to standards and guidelines that are deemed complementary. Robust QMS software usually address these standards in addition to FDA regulations:
FDA, ISO, EU directives, and other regulatory requirements require the establishment of a QMS system. MasterControl quality and compliance software provides an effective framework for a company’s QMS system by automating all documents- and forms-based processes, connecting all quality processes, and providing a centralized location for all documents.
Mobile Access: MasterControl offers a distinct advantage by providing mobile access, allowing users to access information and perform tasks using a tablet or a smartphone. Mobile access will offer greater flexibility for users and help boost overall efficiency and productivity.
Cloud-Based Services: Buying QMS software doesn’t have to be prohibitive. For companies concerned about the high cost of owning a QMS system, MasterControl offers cloud-based services. A cloud-based QMS system offers the same robust system in a secure environment without the need for a huge, up-front cost of, or a large IT staff.
MasterControl QMS software offers the following modules:
To learn more about MasterControl solutions, contact a MasterControl representative