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Design Qualification SOP - eQAPharma设计资质eqapharma SOP
Design Qualification SOP
Document No: SOP_0400 Prepared by: David Brown Date: 16-Aug-2006 Version: 1.0
Document Approval
Name Role Date Signature David Brown Author
Document Control
Version Author Date Description 1.0 David Brown 16-Aug-2006 First version. Table of Contents
1 Introduction 4
1.1 Purpose 4
1.2 Scope 4
1.3 Definitions 4
1.4 Responsibility 4
1.5 References 5
2 Design Qualification – Process 6
2.1 Business Requirements Review 6
2.2 Functional Design Review 6
2.3 Technical Design 7
2.4 Source Code Control 7
2.5 Coding Standards 7
2.6 Code Reviews 7
2.7 Unit (Component) Testing 7
2.8 Validation Change Control Process 7
3 Design Qualification - Phase Entry/Exit 8
3.1 Phase Entry 8
3.2 Phase Exit 8
4 Design Qualification Protocol - Preparation 9
4.1 Protocol Title 9
4.2 Pre-approval 9
4.3 Introduction 10
4.4 Regulatory Requirements 10
4.5 Methodologies 10
4.6 Documents to be reviewed 10
4.7 Acceptance Criteria 10
5 Design Qualification Report 12
5.1 Report on the design evaluation process 12
5.2 Summary and Conclusions 12
5.3 Protocol Results Acceptance 12
Introduction
Purpose
The Design Qualification process ensures that a computer system requiring validation to is designed to meet the regulatory requirements of the pharmaceuticals industry.
Scope
Department/Section: Client, IT and Validation groups.
This SOP will apply to the design of all computer systems that require validation to meet pharmaceutical industry regulatory requirements. For information on computer systems that require validation see SOP SOP_0200 Validation Determination.
Definitions
Project Team – the team formed by the business to implement a new computer system. This team will typical comprise of: a project manager, users, software engineers, IT support staff, trainers, and IT quality assurance staff.
Client – the business system owner is typically the ‘line’ manager responsible for the business process where the computer system will be used.
Validation Group – the group
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