Blood Establishment

Implications & Practical Advice from the Blood Establishment Computer Validation Guidance

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When the FDA released the guidance for “Blood Establishment Computer Validation”, you probably logically thought it didn’t apply to you. While the focus of guidance is explicitly blood establishment computer systems, it represents the FDA’s current expectations for validation of high risk computer systems and includes some of the most explicit requirements released by the FDA for computer system validation. If you haven’t studied this document, you’ve missed a missed a thorough and pragmatic case study of FDA’s current expectations for computer validation of high impact computer systems. The guidance includes specific elements that should be included in validation procedures and cites specific methods and testing that should be performed on these systems.

What You Will Learn

  • Specific validation testing cited in the guidance
  • Practices that should be included in your validation procedures
  • System documentation your organization should be maintaining
  • Expected validation deliverable content, including validation plans, risk assessments and validation reports
  • For enterprise level projects, which validation activities can be performed for the entire organization and which activities must be performed at each site
  • Validation activities the FDA expects after system changes

On Wednesday, October 30 at 1:00pm EST, join FOI Services and Ofni Systems for a 90-minute teleconference to gain practical knowledge about this new computer system validation guidance, including a discussion of the testing, system documentation, validation and change control procedures that your organization needs to have implemented to ensure compliance.

About Ofni Systems

Ofni Systems is an industry leader for 21 CFR Part 11 compliance. Their products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech, and medical device companies across the globe, while it’s products for computer validation, auditing, and FDA submissions ensure that their clients meet every requirement for electronic records and electronic signatures. The company provides live desktop support for superior customer support and training and has been providing solutions to their clients since 1999. For more information, call (919) 844-2494 or visit