1. FDA Part 11 Public Meeting Washington, DC June 11, 2004 Paul D’Eramo Executive Director Worldwide Policy & Compliance Management Quality & Compliance Services Narrowing The Scope Part 11

2. 2 New Approach to Part 11 l Top - Down Approach l Focuses on the Predicate Rule as opposed to the all electronic records created by a firm l Risk-Based Approach l Top - Down Approach l Focuses on the Predicate Rule as opposed to the all electronic records created by a firm l Risk-Based Approach

3. 3 Narrowing The Scope l Definition of Part 11 Records l Appropriate Use of Audit Trails l Records Retention l Legacy Systems l Definition of Part 11 Records l Appropriate Use of Audit Trails l Records Retention l Legacy Systems

4. 4 Scope of Part 11 l Part 11 applies: l When persons choose to use e-records in place of paper l Part 11 does not apply: l When persons use computers to produce paper printouts and rely on paper to perform their regulated activities… l Part 11 applies: l When persons choose to use e-records in place of paper l Part 11 does not apply: l When persons use computers to produce paper printouts and rely on paper to perform their regulated activities…

5. 5 Regulation Definition - Electronic Record “Any combination of text, graphics, data, audio, pictorial, or other information represented in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.” “Any combination of text, graphics, data, audio, pictorial, or other information represented in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.”

6. 6 l Records Required by Predicate Rules: l Electronic format used in place of paper l Electronic format in addition to paper and relied on to perform regulated activities  The Agency may take your business practices into account  Must document your procedure in SOPs l Records Required by Predicate Rules: l Electronic format used in place of paper l Electronic format in addition to paper and relied on to perform regulated activities  The Agency may take your business practices into account  Must document your procedure in SOPs Guideline Definition - Electronic Record

7. 7 Out-of-scope Records and signatures l REMEMBER: Systems may still require validation, qualification, calibration, and other measures and controls aimed at ensuring correct operation and record integrity, based on predicate rule requirements, and the potential impact of that system on product safety and quality.

8. 8  Any “electronic signatures” NOT required by predicate rules, and other superficially similar cases such as identification of individuals, acknowledgement of steps or actions, or logging-on to a system Out-of-scope Examples

9. 9 l For systems generating large amounts of intermediate data which is used to generate the regulated records upon which quality decisions are based, only those records required to meet predicate rule requirements, or submitted to Agency, are in scope, and not all data generated and held by such systems. (Example follows).

10. 10 Out-of-scope Examples l Example: A validated system measures two million capsule weights for a single batch. The system generates a curve showing that batch weight distribution falls within validated norms. The individual data points are not Part 11 records. The expectation of the predicate rule 21 CFR 211.188 is met.

11. 11 Summary l Top - Down Approach: Focus on the Predicate Rule as opposed to the all electronic records l Use a Risk-Based approach as per the guidance l Enable the use of new technology as originally intended l Meet FDA expectations for security and integrity of records l Top - Down Approach: Focus on the Predicate Rule as opposed to the all electronic records l Use a Risk-Based approach as per the guidance l Enable the use of new technology as originally intended l Meet FDA expectations for security and integrity of records