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White Paper Discusses Software Validation For FDA Regulations

Document Control Systems Inc. (DCS), a Salt Lake City-based provider of integrated quality management software solutions, is offering a free white paper and downloadable presentation discussing validation principles for implementing and validating software systems in compliance with industry quality standards and Food and Drug Administration regulations. The white paper, Good System Implementation and Validation Practices for Implementing and Validating Software, and the presentation, which is hosted by Carl Accettura, DCS' senior vice president of FDA solutions, are available at the Document Control Systems Web site. During the 11-minute pre-recorded presentation, Accettura discusses the following topics:

  • realities of software validation;
  • FDA expectations for GxPs (comprised of Good Manufacturing Practice, Good Laboratory Practice and Good Clinical Practice) and 21 CFR Part 11;
  • Good Automated Manufacturing Practice (GAMP) validation framework;
  • risk assessment and risk management planning;
  • processes for implementing and validating quality management systems.
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