2004 FDA Announces Part 11 Public Meeting June 11

FDA has issued a notice of a public meeting to obtain input on changes to the 21 CFR Part 11 Electronic Records;Electronic Signatures regulation. FDA has published a set of questions on which it is requesting input. The link provided is for the federal register notice announcing the meeting and containing the questions. Comments to be considered for presentation at the meeting are due by May 12, 2004 and comments will be accepted for consideration until July 9, 2004.

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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