FDA
Helping Life Science Companies with FDA Compliance
The life science industry is stringently regulated by FDA and EU regulations and current best practices. In order to compete in this regulated environment, companies must comply with EU quality standards. Hundreds of regulated companies worldwide turn to MasterControl 's GxP content and process management solution as they seek to attain and sustain compliance year after year.
FDA Validated Electronic Record Keeping System
EMEA passed Annex 11 to ensure accuracy, reliability, and efficiency in the performance of electronic record keeping systems. Both FDA and EU regulations requires that such systems be validated according to industry best practices, and in so doing hopes to ensure the production of higher quality goods. MasterControl was the first company to create an electronic record keeping system that specifically addressed the regulations unique to the EU-regulated environments. MasterControl helps companies validate their software solutions so they can experience faster software ROI.
White Paper Downloads - FDA Requirements
Implementation and Training Services
In order to realize the full capabilities of MasterControl's electronic content management system, implementation and training services are provided. With more than a decade of experience in the FDA and EU-regulated environments, MasterControl's implementation and training personnel have developed time-tested methods to improve time to market.
During the implementation phase , MasterControl works with the customer's IT department to fulfill the following implementation guidelines:
- Database creation and installation
- Database configuration
The Professional Services team, which consists of former ISO auditors and system administrators with experience in FDA and EU-regulated environments, lead MasterControl's comprehensive training programme. Training services are conducted in the state-of-the-art Training Center in Salt Lake City or at customers' facilities.
For More Information
Learn more about FDA and EU regulations, ISO quality standards, and Sarbanes-Oxley Act requirements at MasterControl's Resource Center. Here, companies concerned with meeting FDA current industry best practices can find all of the following resources:
Contact MasterControl online today or call toll free at 1-800-825-9117.
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