1. The Role of the Technology Provider in the Pharmaceutical Industry
Jean Paty, Ph.D.
Co-founder & Chief Quality Officer
invivodata, inc.

2. 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. Overview Key concepts about computerized systems
Outline roles and responsibilities to include technical persons
Application to GCP environment as example of constructs’ utility

4. 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. 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. 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. 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. 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. 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. 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. 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. GxP TP and Investigator
eDiary System Overview
Investigator
Sponsor
Subject
Investigator
Monitor
Sponsor DM, etc
(Queries, SDV)
eSource
Sponsor database
GxP TP and Investigator

13. Conclusion
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

14. THANK YOU!