Whether the goal is R & D or medical testing, laboratories play an essential role in the prevention, diagnosis, and treatment of diseases and in the overall delivery of health care. Like other life sciences industries, labs invest heavily in research and development of new technologies. Most of all, labs must ensure the quality, accuracy, and integrity of test results and other laboratory data.
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Clinical labs must comply with the Clinical Laboratory Improvement Amendments (CLIA) to be certified to perform testing on human specimens. Labs involved in development of new tests and technologies and in clinical studies also must comply with FDA regulations. FDA-regulated labs maintaining electronic record-keeping systems must comply with 21 CFR Part 11. Public companies or those planning to go public or are acquired by public companies are covered by Sarbanes-Oxley Act (SOX) requirements.
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 making it easier to validate software upgrades, both of which are essential in lowering overall validation cost.
To learn more about clinical and medical laboratory software systems, feel free to contact MasterControl representative today.