Warning Letter: Firm has not validated or documented software changes (ucm516079)

Tags:

Ofni Systems

Failure to establish and maintain adequate procedures for the identification, documentation, validation, or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example: your firm has not validated or documented software changes for the Omega XP Laser System; Omega XP-Clinic Laser System; and Omega Excel Laser System.

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