FDA CBER issued CPG 7342.002 a “Compliance Program Guidance Manual for Inspection of Source Plasma Establishments” Dec 1, 2004. The full document with references to computer systems and software highlighted by SoftwareCPR in yellow is at the link provided.
This manual includes requirements for computer system validation in plasma establishments. It also states that plasma establishment that create their own computer systems/software are subject to the requirements of the Medical Device Quality System Regulation 820. Attachment F Computers goes into more detail on the regulatory requirements for Source Plasma Establishment Computer Software. and under what conditions the software might also require a 510(k) premarket clearance.
It specifically mentions computer security and data integrity provisions must be established and implemented. Section G. item 4 states that software and computers “…used in the manufacture of Source Plasma are validated prior to implementation and qualified at the location where used, and revalidated as required.”
The manual also suggest to FDA inspectors that they inspect computer system functions based on their criticality, problem reports and biologic product deviation reports, and review of change control records.
Keywords: BECS, Blood Establishment, Plasma, CBER