FDA Guidance: Blood Establishment Computer System Validation in the User’s Facility, 4/13

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In April, 2013, the FDA published this Guidance for Industry, Blood Establishment Computer System Validation in the User’s Facility.

This guidance is intended to assist blood establishments in developing computer system validation programs consistent with recognized principles of software validation, quality assurance, and current good software engineering practice.

This comprehensive document includes detailed recommendations on topics such as:

• Software vendor selection
• System documentation and records
• Contents of Validation Plans and Validation Reports
• Validation scope
• System risk assessments
• Validation procedures and activities
• Validation after changes