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Moobaytech

  1. Systems that are properly configured with metadata for electronic submissions are essential
  2. Web based document management and regulatory publishing systems are essential for virtual companies
  3. Good document management is essential for good electronic submissions
  4. Valuable time and money can be lost searching for documents
  5. 1M/week is the approximate amount of lost revenue for each week that your product is not on the market
  6. A non-existent or poorly configured EDMS have a negative impact on your regulatory submissions
  7. A poorly configured document management system can pose many risks for Regulatory Affairs
  8. Running a life science company without a proper document management system is risky
  9. Does your metadata in your document management system meet the requirements for electronic submissions?
  10. Are your documents stored in more than one file location?
  11. Is your organization operating without a document management system?
  12. How should content be managed for subsequent submissions?
  13. Please visit our new website at www.moonbaytech.com
  14. How do you manage/version your native or Word files after a submission to a Regulatory Agency?
  15. If an EDMS is poorly configured, how will electronic submissions and Regulatory Affairs suffer?
  16. Who should be the major players in the EDMS configuration process?
  17. To what extent should Regulatory Affairs play a role in the selection of an EDMS?