FDA Final Electronic Source Data Guidance

FDA issued a FINAL”Guidance for Industry and Food and Drug Administration Staff – Electronic Source Data in Clinical Investigations” Spetember 2013. The full document is at the link provided. It discusses the value of electronic source data for clinical investigations as well as types of controls to ensure integrity and trace origin. AMong other requirements it states: “When data elements are transcribed from paper sources into an eCRF, the clinical investigator(s) must also retain the paper sources, or certified copies, for FDA review. Other records (electronic and paper) required to corroborate data in the eCRF (see section III.A.2.a) may also be requested by FDA during an inspection.

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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