Compliance with FDA regulations is part of doing business for life science companies. Regulations exist to protect consumers and the public in general. They are a major driving force for companies to manufacture and sell products (or provide services) that are safe, reliable, and effective.
Since 1993, hundreds of companies in a wide range of regulated industries have relied on the MasterControl™ integrated quality management suite to attain and sustain compliance with FDA regulations such as:
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A laboratory's ultimate goal is to ensure the accuracy and quality of tests. To achieve this goal, the lab must address many challenges, including:
Compliance is a state, not an event. A laboratory must not only attain compliance, but sustain it year after year. The MasterControl™ integrated quality management suite is a configurable, easy-to-use solution that helps companies attain and sustain compliance with FDA and other regulations by automating and managing quality processes in an efficient and cost-effective manner.
Recognizing that validating a software solution and keeping it in a constant state of validation is half the battle in sustaining compliance, MasterControl is actively developing new ways to reduce the time and effort involved in validating a system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.
In this question-and-answer article, MasterControl Inc. interviewed a CDER official who discussed:
The MasterControl™ integrated quality management suite is a configurable, easy-to-use solution that helps companies attain and sustain compliance. MasterControl connects different departments with each other and with data and processes under a secure and centralized web-based system. This connectivity helps promote quality throughout the enterprise by allowing management to continuously monitor and proactively improve the quality processes. MasterControl helps pharmaceutical companies meet key CGMP requirements and ISO quality standards, and at the same time increase efficiency and keep compliance costs down.
To get quality software solutions from MasterControl regarding automating life science business processes, feel free to contact a MasterControl representative today.