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.

confidential 2000 1

2004 121 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.

2004 221 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

2004 321 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

2004 421 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.”

2004 521 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

2004 621 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).

2004 721 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.

2004 821 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.

2004 921 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.

2004 1021 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

2004 1121 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

2004 1221 CFR Part 11 Public Meeting

eSourceSponsor database

Sponsor DM, etcInvestigatorSubject Monitor

SponsorInvestigator

GxP TP and Investigator

(Queries, SDV)

eDiary System Overview

2004 1321 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

2004 1421 CFR Part 11 Public Meeting

THANK YOU!