CLINICAL TRIAL DATA VALIDATION

PLAN (DVP) TEMPLATE

STUDY NAME
PROTOCOL NO.	VERSION NO.	DATE
INVESTIGATIONAL PRODUCT NAME
IND NO.	TRIAL PHASE
SPONSOR(S), NAME, AND ADDRESS
FUNDING ORGANIZATION
PRINCIPAL INVESTIGATOR, NAME, AND CONTACT INFORMATION

APPROVED BY:

Project Data Manager Name (Printed)
Project Data Manager Signature	Date

Principle Investigator or Sponsor Name and Title (Printed)
Principle Investigator or Sponsor Signature	Date

TABLE OF CONTENTS

1.	INTRODUCTION	3

2.	COMPUTER SYSTEMS –– SELECTION AND CLASSIFICATION	3

SELECTION	3

RISK ASSESSMENT	3

CLASSIFICATION	3

DESIGN QUALIFICATION	3

CLASSIFICATION AND SELECTION OF RECORDS	3

3.	VALIDATION PROTOCOL	3

DESIGN QUALIFICATION	3

INSTALLATION QUALIFICATION	3

OPERATIONAL QUALIFICATION	3

PERFORMANCE QUALIFICATION	3

DEVIATIONS	3

4.	VALIDATION REPORTS	3

INTRODUCTION

Describe the goal and scope of this data validation plan, including how the plan will ensure the processes comply with quality and regulatory requirements and how it will maintain the data safety and integrity. Detail who has responsibility for the application of this procedure and who manages the computerized system.

COMPUTER SYSTEMS –– SELECTION AND CLASSIFICATION

Describe the selection and classification of the computer system and its eligibility to design qualifications.

STEP	DESCRIPTION AND PURPOSE
Selection	Describe how the staff chose the computer system.
Classification	Describe the level of concern for equipment/software validation: installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
Design Qualification	Describe if the equipment requires design qualification, based on its features.

SELECTION

Detail if staff need to validate the computer system. Detail the electronic format in which the software stores the records, whether the computer system electronic signatures are equivalent to ink signatures, whether the staff will use the system with quality management, and whether the system meets CFR regulations.

RISK ASSESSMENT

Detail how staff will conduct a risk analysis to assess the consequences of software failure. Consider the consequences on the following:

Production

Servicing

Quality and regulatory data

All software

CLASSIFICATION

Detail the classification criteria and any associated risks (i.e., if the system is compliant with 21 CFR part 11). Detail what makes the system the following level of risk for the sequence of events:

High

Medium

Low

DESIGN QUALIFICATION

Describe the origin and degree of the configuration of the system (i.e., off the shelf, developed internally, or text document/spreadsheet), and how staff will assess it.

CLASSIFICATION AND SELECTION OF RECORDS

Describe how staff will use the computer system to create forms and tables to inventory the computer system.

VALIDATION PROTOCOL

Describe the validation protocol with the following steps:

Design Qualification

Installation Qualification

Operations Qualification

Performance Qualification

DESIGN QUALIFICATION

Describe how the software will address the following milestones and tasks for software design qualification:

Project launch

Risk Assessment

Specifications with risk mitigation

Design review

Verification

Design validation

INSTALLATION QUALIFICATION

Describe the installation qualification steps to ensure staff install the system properly.

Verify the following:

HARDWARE
Hardware installation
Hardware customization or settings
Network connections
Peripherals
Hardware maintenance contracts
IN CLOUD SYSTEMS
Cloud server settings
Cloud server contract
MATCHING SETTINGS WITH REQUIREMENTS
Operating system version
Server version
Virtual machine version
VERIFY SOFTWARE DOCUMENTATION AND VERSION
Installation, administration, and user manual
DQ output documentation
QMS procedures and instructions
SOFTWARE INSTALLATION
Proper installation
Software version
Installation results
MIGRATION OF DATA
Proper migration
Data migration logs
SOFTWARE CONFIGURATION
Settings
Steps logs

Describe how staff will document and record installation qualifications.

OPERATIONAL QUALIFICATION

Describe how staff will ensure that all system functions work as expected, including the following:

Functional and performance requirements

Nonfunctional requirements (i.e., security, backup)

Describe how staff will document and record operational qualifications.

PERFORMANCE QUALIFICATION

Describe how staff will ensure that the computer system works as required in its target environment with target users. Describe how staff will document and record performance qualifications.

DEVIATIONS

Describe how staff will record deviations and software bugs: major, medium, or minor.

VALIDATION REPORTS

Describe the reporting requirements for the study, including qualification and final validation reports.

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