Software Validation for Computerized Food Processing Systems John W. Larkin, Ph.D. Food and Drug Administration National Center for Food Safety and Technology, Chicago, IL FDA Advanced LACF course June 4 - June 15, 2001

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21 CFR Part 11 A Food Industry Perspective FDA
Public Meeting June 11, 2004
Sia Economides Center Director Center for
Development of Research Policy and New
Technologies National Food Processors Association
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• National Food Processors Association (NFPA)
• Is the principle scientific and technical trade
  association representing the 500 billion dollar
  food processing industry on government and
  regulatory affairs, scientific research,
  technical assistance, education, communications
  and crisis management.

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Food Industry Perspective

• Original Concerns
• Which electronic records need to comply?
• What about legacy systems?
• What do we need to validate?
• With the new guidance document, primary concerns
  of e-records and legacy systems are addressed
• What about validation?

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Validation

• Existing Documents in Use by the Food Industry
• FDA Guide to Inspections of Computerized Systems
  in the Food Processing Industry, 1998
• NFPA Guideline 43-L Bulletin Validation
  Guidelines for Automated Control of Food
  Processing Systems (based on GAMP)

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Risk Analysis Approach

• NFPA Members agree with the risk-based approach
  to compliance

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Risk Analysis Approach inthe Food Industry

• Currently
• FDA Food Regulatory Requirements are risk based
• HACCP based on risk analysis
• Risk Assessment tools for RTE refrigerated
  products
• Focus of the Risk Analysis is on Public Health

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Recommendations

• Given that
• 11.1 and 11.2 are addressed in recent guidance
• 11.3 is addressed in existing guidance and
  technical documents
• 11.10, 11.30, 11.50, 11.70 are addressed in
  existing guidance documents and predicate rules
• Whats left that cannot be addressed in guidance?
  

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Recommendations

• We recommend
• Rescinding the regulation
• Addressing the additional requirements through
  guidance
• Focus on defining the intent Let Industry
  identify how to comply
• Provides for
• Specificity to industry segments
• Getting away from one size fits all
• New Technology to be implemented