Whether a FDA-regulated company is training its employees on the basics of 21 CFR Part 11 or training employees to become users of a Part-11 compliant electronic system, part 11 training is essential to achieving 21 CFR Part 11 compliance.
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Since its original release in 1997, FDA 21 CFR Part 11 has changed and evolved to match the needs of life science companies using software technology to manage their GxP processes. Life science companies must conduct FDA 21 CFR Part 11 training so that their personnel know how to ensure the ongoing maintenance of the electronic system according to industry best practices. MasterControl Inc. provides GxP process management software solutions to help regulated life science companies conduct FDA 21 CFR Part 11 training with greater ease to ensure regulatory compliance.
MasterControl Inc. is a leading global provider of GxP process management software solutions dedicated to helping life science companies easily deploy, validate, and maintain their FDA 21 CFR Part 11 training software. MasterControl™ incorporates industry best practices for automating and connecting ever stage of the product development cycle, ensuring that FDA 21 CFR Part 11 training processes are connected to change control, document control, and CAPA processes. With over a decade of experience, MasterControl provides time-tested software solutions to the day-to-day challenges of sustaining regulatory compliance.
FDA 21 CFR Part 11 requires life science companies to demonstrate that the software they employ consistently does what the company intends it to do. 21 CFR Part 11 training is needed so all people involved with the validation process know how to maintain the system according to industry best practices.
MasterControl 21 CFR Part 11 training software solutions automate the assignment and monitoring of training tasks and grading of online exams so regulated companies are always ready for inspections and audits.
MasterControl suite distinguishes itself from other FDA 21 CFR Part 11 training software providers by keeping companies compliant, connected, and complete.
MasterControl believes that compliance with FDA 21 CFR Part 11 training requirements is a state, not an event. MasterControl optimizes quality and business processes by fostering efficiency and lowering compliance costs. Connected: MasterControl FDA 21 CFR Part 11 training software solutions are integrated to effectively connect people with data and processes so life science companies can see the big picture across their enterprise.
MasterControl believes that FDA 21 CFR Part 11 training initiatives must be integrated into an organization's corporate culture. Along with a web-based platform, MasterControl offers a line of validation products and services to allow continuous validation.
Subscribe to GxP Lifeline today to learn more about FDA 21 CFR Part 11 training requirements and MasterControl's software solutions. Each edition of this complimentary monthly newsletter includes features stories, articles, life science news, life science events, and a best-practice tip to help regulated companies make the right decisions about regulatory compliance.
To learn more about MasterControl's software systems, please contact a MasterControl representative.
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