Insights into FDA CFR 11 and packaging (sidebar)

Mike Haldane of 3M delivered a presentation entitled “FDA CFR 11 and Packaging” at a conference session at Pack Expo International, held in Chicago in November.

In it, he provided an overview of the FDA’s CFR Part 11 guidelines, the impact of poor quality, the importance of packaging, and gaining a return on investment.

Haldane quoted 3M quality consultant Nancy Alcorn with this guideline overview: “The intent of CFR Part 11 is

to ensure data integrity, by selling minimum standards for accuracy, trustworthiness, and reliability of rewards.

“Computerized systems should provide the same degree of confidence as paper systems. The ability to store and retrieve ever-growing quantities of e-data is a challenge for most companies and should be an integral component of any comprehensive CFR Part 11 compliance plan.”

Insights into poor quality

• Companies have incurred millions in FDA fines, some in excess of $500 million.

• Approximately 50% of all recalls are due to packaging errors.

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