PIC/S PE 005-3 GMP Guide for Blood Establishments, 9/07

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In September, 2007, PIC/S published this guidance for GMP-inspectors to use during inspections of blood establishments.

Note sections 9.8 – 9.13 for recommendations on computer system validation, security, backups, training, change control, and retention of change records.

See sections 11.19 – 11.20 for additional recommendations to apply when the computer system is used for blood product release.