FDA Drug & Biologics Data Integrity Draft guidance

FDA issued a draft guidance for Drugs and Biologics titled: Data Integrity and Compliance With CGMP. While s number of the concepts are conceptually relevant to device manufacturers one must be careful with interpretation since the requirements in this guidance are specifically related to elements of the Drug CGMPs and these are not identical to the requirements of Device CGMPs in 21 CFR 820 and related regualtions.

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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