GxP Lifeline reporters regularly consult with government and association publications including FDA Medwatch, U.S. FDA Center for Drug Evaluation and Research (CDER), American Association of Blood Banks (AABB), and others to gather information pertinent to employees in the medical arena.
Particular attention is paid to regulatory issues because of their impact on medical manufacturing, clinical studies and pharmaceutical laboratories. CFR Part 11 compliance, CFR Part 11 software, corrective action plans and FDA requirements are all regularly reviewed in the newsletter.
Because of recent guidelines issued by the FDA, the newsletter also covers issues pertinent to electronic document control. Readers will enjoy articles about document control software, electronic document management, online document management systems, enterprise document management systems and change control software.
Life science news also encompasses all areas of total quality management. GxP Lifeline reports on total quality management and information technology as it relates to pharmaceutical and medical device areas. Total quality management in health care is covered too, as it relates to blood and tissue organizations. The publication also covers total quality management tools useful to life science companies.
To learn more about MasterControl, computer system validation and compliance with 21 CFR Part 11, visit MasterControl's Resource Center. The Resource Center offers industry white papers, product data sheets, Q & A's, case studies and webinars which provide extensive information for companies seeking new tools for change management.
Contact MasterControl online or call toll free at 1-800-825-9117.