PIC/S PE 011-1 Guide to Good Distribution Practice for Medicinal Products, 6/14

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In June, 2014, PIC/S Guide to Good Distribution Practice for Medicinal Products went into effect to ensure high standards of quality assurance and integrity for distribution of medicinal product.

The following sections provide guidance for computer systems and software:

• Section 3.2.3 requires validation for any system providing segregation of products
• Section 3.5.1 requires validation or verification of system prior to use
• Section 3.5.2 requires up-to-date, written documentation of systems
• Section 3.5.3 requires authorization for people who enter or change data
• Section 3.5.4 requires data protection and retention
• Section 3.5.5 requires implementation of procedures to be followed in the event of system failure
• Sections 4.2.1 and 4.2.9 allow for computerized record retention and specify required data elements