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

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.

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?

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)

Risk Analysis Approach NFPA Members agree with the risk-based approach to compliance

Risk Analysis Approach in the 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

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, are addressed in existing guidance documents and predicate rules What’s left that cannot be addressed in guidance?

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