Tuesday, January 19, 2010

Transfer of Clinical and Regulatory Submission Data and Documentation for QC

Clinical and regulatory data and documentation presented for QC must be version-controlled, protected and transferred from one site to another, one location to another, worldwide, with proper security via standard process, procedure and acceptable media.

For QC to be effective, clinical and regulatory submission data and documentation must be transferred via acceptable media:

  • floppy disk
  • paper
  • CD
  • DVD
  • DLT
  • shared secured, password protected drives
  • FTP servers - secured, password protected
  • a validated, process-controlled documentum tool
  • a validated, process-controlled publishing tool
  • a validated submission-ready template
  • pharma servers - proprietary and protected.

Clinical and regulatory submission data and documentation for QC must not be transferred at any time or under any circumstance via unacceptable media:

  • email
  • excel spread sheet
  • fax
  • telephone
  • blackberry
  • power point slides.

According to QC and GCP (Good Clinical Practice) guidance, clinical and regulatory submission data and documentation must be securely transported and version-controlled. Any media that allows modification to the data and documentation, before, during or after transport is unacceptable according to ICH, GCP, SOP, FDA standards. A QMP (Quality Management Plan) SOP outlining the process, procedure and transport of clinical and regulatory data and documentation is recommended. Adherence to the SOP is strongly advised without deviation.

No comments:

Post a Comment