Session T3-1, Track 3 “Computerized Systems Validation in ... t3-1_kim nitahara.pdfMay 17, 2011...

Session T3-1, Track 3 “Computerized Systems Validation in the e-Clinical System’s Life Cycle

May 17, 2011 | Beijing, China

Kim NitaharaPrincipal Consultant and CEOMETA Solutions, Inc. (USA)

• To understand the requirements and processes for the validation of computerized systems used in clinical

Purpose of this session:

computerized systems used in clinical trials

• To review key issues related to computerized e-clinical systems validation

2www.diahome.orgDrug Information Association

• What is a computerized system?

• What is computerized systems validation?

Computerized Systems Validation Topics:


• What are the regulatory requirements for e-

clinical computerized systems validation?

• What does a validation include?


What is a computerized system?• Hardware• Software• Trained Personnel


• Procedures• Infrastructure and

Equipment

PIC/S PI 011-3 Good Practices for Computerised Systems in Regulated ‘GXP’ Environments)

“Confirmation by examination and provision of objective evidence that software specifications conform to

What is computerized system validation?

software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled”

(FDA Guidance: General Principles of Software Validation)5www.diahome.orgDrug Information Association

(another definition)

“Establishing documented evidence

What is computerized system validation?

Establishing documented evidence that a computerized system conforms with user requirements, and that it will continue to do so in the future”

(PMA/IEEE/Consensus Workshop)


“The computerized systems should be

What are the Regulatory requirements for e-clinical computerized systems?

designed: (1) to satisfy the processes assigned to these systems…; and, (2) to prevent errors in data creation, modification, maintenance, archiving, retrieval or transmission.”

(FDA Guidance: Computerized SystemsUsed in Clinical Investigations IV.A)


“The sponsor is responsible for

What are the regulatory requirements for e-clinical computerized systems?

p pimplementing and maintaining quality assurance… systems… to ensure that trials are conducted … in compliance with the protocol [and] GCP…”

(ICH E6 GCP Guidance)8www.diahome.orgDrug Information Association

“Validation of systems to ensure


yaccuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.”

(FDA 21 CFR 11.10a Controls for Closed Systems)


• Ensure and document…validation.


• Maintain SOPs for using these systems.• Maintain an audit trail…• Maintain a security system…• Maintain adequate backup of the data…”

(ICH E6 GCP Guidance 5.5)10www.diahome.orgDrug Information Association

• Ability to Generate Accurate and Complete Copies


• Protection of Records

• System Controls

• Validation

• Audit Trails

• Personnel Training


(FDA 21 CFR 11.10 Controls for Closed Systems)

• Has the software been validated?


• Who validated the software?• What was the process used to validate the

software?• How was the validation process documented?

(CP 7348.810 Sponsors, Monitors and CROs)


• Computerized systems used to:- Create - Modify

Which systems should be validated?

- Maintain - Archive - Retrieve - Transmit

data intended for submission to FDA


• Written Design Specification– “what the software is intended to do and how it is

What are the minimum requirements for computerized systems validation?

intended to do it”

• Written Test Plan– “structural and functional analysis”

• Test Results and Evaluation– “demonstrate the… specification has been met”

(Clinical Systems Guidance VIII.B.2 System Dependability)


• “Software validation is a matter of developing a level of confidence”

What are the minimum requirements for computerized systems validation?

level of confidence• “The level of confidence, and therefore the level of

software validation, verification, and testing effort needed, will vary depending upon the safety risk(hazard) …”

(General Principles of Software Validation3.1.2 Verification and Validation)


Example of risk evaluation

Source Record


Monitoring Report

Query Log

Paper CRF

eCRF Data

“Risk”

• Validation Plan• Requirements Specification

User Functional Technical

What does a typical validation include?

– User, Functional, Technical

• Design Specification• Test Plans

– Completed Test Results

• Test Reports• Validation Report

)17www.diahome.orgDrug Information Association

Example computer validation project documentation

ValidationPlan SOPs

Validation Summary

Report

Remediation Plans and

Results

Test Plans & Reports

(IQ/OQ/PQ)

VendorAudit

Compliance and Risk

Assessments

Employee Training Records

Software Documentation“Validation

Package”

• What is a computerized system?

What is computerized systems validation?

Summary of Validation Topics:


• What are the requirements for e-clinical

computerized systems validation?

• What does a validation include?


• Computerized systems include hardware, software, trained personnel, SOPs, and infrastructure

Conclusions:

infrastructure• Regulations require e-clinical systems to

be validated to ensure that they will consistently and reliably meet the needs of the user performing the clinical trial


• At a minimum, e-clinical systems validations require 1) a written design specification 2) a written test plan and 3)

Conclusions (continued):

specification, 2) a written test plan, and 3) documented test results that demonstrate that the specification has been met.

• The amount of validation effort should depend on the significance (risks) of the e-clinical system and data in a clinical trial


Questions and discussiondiscussion

[email protected]

Drug Information Association www.diahome.org 22

Session T3-1, Track 3 “Computerized Systems Validation in ... t3-1_kim nitahara.pdfMay 17, 2011...

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