FDA · Life Science & Pharma: GxP - CSV & Data Integrity
Blood Establishment Computer System Validation in the User's Facility (FDA guidance)
Final CSV · Guidance Last verified: not yet · Source last checked 3 Nov 2026
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FDA's guidance on validating the computer systems that blood establishments use. It is also a compact example of a validation plan.
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Lifecycle
Solid steps have happened. A dashed step is expected, and it is not a fact. Only dated steps in our record appear here.
- Final guidance issued (April 2013)
In plain English
FDA guidance on how a blood establishment validates its computer system, including blood establishment computer software, in its own facility.
Summary drafted with AI assistance. Not yet reviewed by the SME Reviewer. Read the official text before acting.
Context and history
FDA issued this guidance in April 2013 for blood establishments validating their own computer systems. It explains what validating in the user's facility means, using familiar stages of qualification.
Who and what it applies to
Blood establishments using Blood Establishment Computer Systems and Software.
What it contains
- Background
- Describes blood establishment computer systems and software, and key definitions.
- Planning
- Vendor selection, system documentation, validation plan, scope and risk assessment.
- Execution
- Validation procedures, activities, reports and validation after a change.
- Integrated or stand-alone
- How validation differs for packages.
Key points
- It gives a worked approach to validation for one regulated sector.
- Validation continues after a change.
- Vendor selection is part of validation.
In practice
General reading, not advice. This is drafted with AI and may not fit your situation. It does not replace the official text, your own quality system or qualified advice, and an inspector may take a different view.
- Even outside blood establishments, it is a useful, compact example of a validation plan's structure.
Read from the source document on 1 Nov 2026. This is our own description, not the official text. Check the full dated history in the change log below.
Change log
Key dated events only, not a complete history. Status after is the status once that event happened. Event kinds explained
| Date | Event | Status after | Source |
|---|---|---|---|
| ~1 Apr 2013 | Final guidance issued (April 2013) | Final | Source for Final guidance issued (April 2013) |
Related
How other documents connect to this one. Links explained
- Related to FDA software validation· Compare with FDA software validation Unverified link
Official source
The official text always prevails over anything on this site.
Source: FDA. Public domain.
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