# Presentation: 658180

## Industry Coalition on part 11

- FDA Part 11 Public Meeting
- June 11, 2004
- Frank J. Sena PhD
- Fred Razzaghi

## Industry Coalition on Part 11

- We appreciate the opportunity to present our views.
- We support and applaud the FDA in its efforts to protect public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
- We also support initiatives such as the GMP initiative to enhance drug quality through better science and risk management.

## Industry Coalition on Part 11

- Review of this rule and the guidance issued in 2003 are consistent with FDA’s mission and current thinking.
- Our goal is to work with you to attain a practical and enforceable outcome that allows both FDA and industry to meet our primary objectives.

## Industry Coalition on Part 11

- The Industry Coalition on Part 11 represents 13 Trade Associations whose products include human and veterinary drugs, animal feed, cosmetics, medical devices, foods, and dietary supplements.
- As principal stakeholders these associations represent the bulk of the industry sector affected by this rule.

## Advanced Medical Technology Association
America’s Blood Centers
Animal Health Institute
Biotechnology Industry Organization 
Consumer Healthcare Products Association
Cosmetic, Toiletry, and Fragrance Association
Council for Responsible Nutrition 
Council on Radionuclides and Radiopharmaceuticals
Generic Pharmaceutical Association 
Medical Device Manufacturers Association
National Electrical Manufacturers Association
National Food Processors Association 
National Grain and Feed Association
Pharmaceutical Research and Manufacturers of America

- America’s Blood Centers
- Animal Health Institute
- Biotechnology Industry Organization
- Consumer Healthcare Products Association
- Cosmetic, Toiletry, and Fragrance Association
- Council for Responsible Nutrition
- Council on Radionuclides and Radiopharmaceuticals
- Generic Pharmaceutical Association
- Medical Device Manufacturers Association
- National Electrical Manufacturers Association
- National Food Processors Association
- National Grain and Feed Association
- Pharmaceutical Research and Manufacturers of America

- Industry Coalition
- on 21 CFR
- Part 11

## Industry Coalition on Part 11

- Our remarks follow the comments made by Dr. Goldhammer, Mr. Liebler and the other coalition representatives on the objectives of the coalition.
- We maintain that prescriptive regulation of computer technology tools used in the manufacture of regulated products is neither practical nor enforceable.

## Industry Coalition on Part 11

- Reasons

## Industry Coalition on Part 11

- Prescriptive rule-making creates obsolescence at inception. Technology in general, and this one in particular is subject to continuous, rapid and dynamic innovation and does not follow along the predicted track contemplated by a rule.
- Computer technology is only a tool used by manufacturers and regulators in multitudes of ways and applications to facilitate and realize the primary goals of meeting safety, efficacy and quality in regulated products. We have had success focusing on what we know best. The predicate rules already contain the primary provisions.
- Stand alone enforcement has been difficult. FDA has recognized the need to reference the underlying predicate rules in compliance actions.

## Industry Coalition on Part 11

- Assuring complete compliance has proven unattainable. Generally, industry as well as the regulators, are users of software products and lack the software manufacturers’ expertise.
- The tremendous strides made by the  solution providers have fallen short of expectations as determined by the regulator or industry.

## Industry Coalition on Part 11

- Understanding, acceptance and standards have evolved significantly since the rulemaking process began.
- Identifying hardware as equipment and software as a record are examples of rule making difficulties that is in contrast to reality in many instances.

## Industry Coalition on Part 11

- General comments on the questions posed by the FDA

## Industry Coalition on Part 11

- The significant and still relevant portions of the rule are addressed and interpreted as acceptable practice within the predicate rules or current industry practice. Clarify such with a guidance if appropriate e.g. authenticity, security, record requirements and electronic submissions.

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## Industry Coalition on Part 11

- We recommend FDA rescind the rule.
- Use technical definitions as they appear in current recognized standards. Keep the vocabulary away from jargon and close to predicate rule language.

## Industry Coalition on Part 11

- An organization’s internal standard operating procedures are the appropriate place for identifying records subordinating to how predicate rules are adhered to and executed (electronic or paper).
- A prescriptive approach in this instant is limiting. Recognizing the capabilities of software products and flexibility in a variety of applications obviates the benefits of outlining general requirements (security, authenticity, authority). Making a list of critical items or rules may fall short of communicating clear and comprehensive expectations.

## Industry Coalition on Part 11

- To fully benefit from the lessons learned, the appropriate use of risk management would be warranted subject to promulgation of an FDA guidance or recognized risk management guidelines and standards.
- 	FDA’s objective to assure record security and authenticity may be met with an enabling guidance in conjunction with existing predicate rules and risk management in an integrated approach that can be both practical as well as enforceable.

## Industry Coalition on Part 11

- Clarity is provided by technical standards and identification of expected regulatory outcomes (e.g record security). Our mutual goal should be to encourage the use of electronic records technology as a tool to facilitate and continuously improve regulated products’ quality within the context of predicate rules including record security, authenticity, and organizational accountability.

## Industry Coalition on Part 11

- We call on all Part 11 solution providers to refocus their efforts and help the industry and regulators meet their objectives as framed here:
- Provide support for use of technology tools
- Predicate rule interpretation and application
- Practical solutions and implementation
- Compliance with enforcement expectations

## Industry Coalition on Part 11

- We will continue to support this effort and assist the policy making process by sharing our experience and knowledge from investments in operations and technology.
- Thank you.