1. confidential2000 1 2004 1 21 CFR Part 11 Public Meeting The Role of the Technology Provider in the Pharmaceutical Industry Jean Paty, Ph.D. Co-founder & Chief Quality Officer invivodata, inc.

2. 2004 2 21 CFR Part 11 Public Meeting Summary The pharmaceutical industry looks to improve processes and increase efficiencies using technology as an enabler Industry often uses experts to implement and support technical solutions in all areas Technical experts/entities are not explicitly identified or covered in the regulations Definition of experts’ responsibilities in 21 CFR Part 11 can clarify the role of GxP Technology Providers for the industry

3. 2004 3 21 CFR Part 11 Public Meeting Overview Key concepts about computerized systems Outline roles and responsibilities to include technical persons Application to GCP environment as example of constructs’ utility

4. 2004 4 21 CFR Part 11 Public Meeting Regulatory Expectations 1999 FDA Guidance: ALCOA “To be acceptable the data [from clinical trials] should meet certain fundamental elements of quality whether collected or recorded electronically or on paper. Data should be attributable, original, accurate, contemporaneous, and legible.”

5. 2004 5 21 CFR Part 11 Public Meeting System Structure vs. System Content Computerized system –Combination of software, hardware and processes used in system implementation System Structure –Controls and procedures designed and built into a computer system System Content –The electronic records themselves

6. 2004 6 21 CFR Part 11 Public Meeting System Owner The person (or entity) responsible for ensuring that the computerized System Structure can produce records that meet FDA requirements for record authenticity, ALCOA (data integrity), and confidentiality (where appropriate).

7. 2004 7 21 CFR Part 11 Public Meeting Record Owner Person responsible for ensuring that the System Content (electronic records) is compliant with FDA requirements for record authenticity, ALCOA (data integrity), and confidentiality (where appropriate). Under some circumstances, the System Owner and the Record Owner may be the same person.

8. 2004 8 21 CFR Part 11 Public Meeting GxP Technology Provider This person, on behalf of the System Owner, would develop and validate the System Structure to ensure that it can manage ALCOA compliant records. This person, as the technical expert, can also support the Record Owner in their responsibilities related to producing ALCOA compliant electronic records. By definition, the System or Record Owners could carry out any and all of the tasks of the GxP Technology Provider since these fall under their regulatory responsibilities.

9. 2004 9 21 CFR Part 11 Public Meeting Implications Contractual relationships among System Owner, Record Owner, and GxP Technology Provider need to be clear. There no transfer of obligations to the GxP Technology Provider. The GxP Technology Provider becomes a regulated entity. Everyone is thus held responsible to the FDA regulations and ALCOA.

10. 2004 10 21 CFR Part 11 Public Meeting Application to Clinical (GCP) Context Using the example of electronic diaries (eDiaries) implemented in clinical trials One inherent characteristic of eDiaries is that the electronic record is the source data –There is no original data on paper

11. 2004 11 21 CFR Part 11 Public Meeting Application to Clinical (GCP) Context: eDiary Roles and responsibilities: –System Owner = Sponsor –Record Owner = Investigator –GxP Technology Provider = External Vendor GxP Technology Provider –Builds and validates eDiary system –Hosts eSource data for investigator –Supports both System and Record Owners

12. 2004 12 21 CFR Part 11 Public Meeting eSource Sponsor database Sponsor DM, etc Investigator Subject Monitor SponsorInvestigator GxP TP and Investigator (Queries, SDV) eDiary System Overview

13. 2004 13 21 CFR Part 11 Public Meeting GxP Technology Providers are an integral component of the Pharmaceutical Industry GxP Technology Providers should be explicitly identified in the regulations GxP Technology Providers will have direct responsibility to meet FDA regulations Definition of experts’ responsibilities in 21 CFR Part 11 will clarify the role of GxP Technology Providers for the industry Conclusion

14. 2004 14 21 CFR Part 11 Public Meeting THANK YOU!