In today's world of regulated pharmaceuticals, it's no longer good enough to say you run a laboratory that adheres to best practices; now you must use cGLP software systems to prove it.
There is a set of FDA regulations (21 CFR 58) that must be applied in order for a laboratory to claim Good Laboratory Practice (GLP) compliance. 21 CFR 58 describes good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration.
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cGLP software helps a laboratory with document control, organizing and storing the records that allow them to maintain the GLP designation. GLP data records that are stored in cGLP system include:
cGLP software can also help laboratories with global regulatory requirements to improve quality and ensure compliance. These solutions, include:
For compliance to standards of current good laboratory practices, the global regulatory bodies continue to require all core processes and systems within a company to be identified, evaluated, and prioritized. MasterControl's cGLP system allows companies to attain compliance, and all the following, from a trusted professional software company:
MasterControl ensures that all standards to assure cGLP are met and sustained in hundreds of regulated companies worldwide.
MasterControl was the very first content and quality management system provider to offer software applications that directly address the challenges of complying with cGLP and other global quality regulations. The software solutions include integrated, easy-to-use applications that help companies automate the requirements of GLP compliance, such as GLP audit, GLP training, and other requirements.
For more information about cGLP software for ensuring GLP compliance, please feel free to contact a MasterControl representative.