Title Design Qualification SOP

Version Status Date Page

1.0 Commercial in Confidence 16-Aug-2006 1 of 13

Design Qualification SOP

Document No: SOP_0400

Prepared by: David Brown
Date: 16-Aug-2006
Version: 1.0
Title Design Qualification SOP
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1.0 Commercial in Confidence 16-Aug-2006 2 of 13

Document Approval

Name Role Date Signature

David Brown Author

Document Control

Version Author Date Description

1.0 David Brown 16-Aug-2006 First version.
Title Design Qualification SOP
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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
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1 Introduction

1.1 Purpose
The Design Qualification process ensures that a computer system
requiring validation to is designed to meet the regulatory
requirements of the pharmaceuticals industry.

1.2 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.

1.3 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 responsible for ensuring that
computer systems are implemented and maintained in a validated
state.
IT Group the group responsible for development, operation, and
maintenance of computer systems.

1.4 Responsibility
The overall responsibility to ensure that the DQ is carried out in
accordance with this SOP lies with the Business System Owner.
The Project Team are responsible for ensuring that they follow the
process described in this document is followed.
The Validation group is responsible for the production of the Design
Qualification Protocol document and Design Qualification Report.
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1.5 References

Document ID Title
SOP_0102 Document Standards
SOP_0401 Code Review SOP
SOP_0402 Unit Testing SOP
SOP_0900 Validation Change Control SOP
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2 Design Qualification Process

2.1 Business Requirements Review

The User requirements must be documented either as a conceptual
description of the system or as a formal statement of user
requirements prior to the start of the validation process.
The User requirements specification must be reviewed to ensure
that the appropriate regulatory conformance requirements are
present. These requirements relate to:
US Food and Drug Administration 21 CFR Part 211 Current
Good Manufacturing Practice For Finished Pharmaceuticals
US Food and Drug Administration 21 CFR Part 11
Guidance for Industry Part 11, Electronic Records; Electronic
Signatures Scope and Application
International Committee for Harmonization (ICH)
Guidance for Industry E6 Good Clinical Practice:
Consolidated Guidance
International Committee for Harmonization (ICH)
Electronic Standards for the Transfer of Regulatory
Information (ESTRI)
International Committee for Harmonization (ICH)
Electronic Common Technical Document Specification
US Food and Drug Administration Guidance for Industry:
Computerized Systems Used In Clinical Trials
US Food and Drug Administration 21 CFR Part 58 Good
Laboratory Practice For Nonclinical Laboratory Studies
All Requirements should have a unique identifier to allow for
traceability of system functionality back to requirements.

2.2 Functional Design Review

The functional design must be reviewed to ensure the business
requirements, specifically the regulatory requirements, are
addressed in the Functional Requirements Specification. The
compliance related functions are:
The use of electronic signatures;
Access control mechanisms;
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Audit trails;
Backup and recovery;
Resilience and data integrity, and;
Disaster recovery.

2.3 Technical Design

Ensure that the technical design specification provides a concise
definition of each software module. These definitions must be
traceable back to business functions expressed in the Functional
Requirements Specification.

2.4 Source Code Control

Ensure that all source code related to a validated system is stored
in a validated source code control system unless manual
procedures are in place to ensure the version management of
source code during development.

2.5 Coding Standards

Coding standards are vital to ensure consistency and supportability
of a computer system. As part of the DQ process it is the
responsibility of the project team to ensure that coding standards
are employed.

2.6 Code Reviews

Evidence must be present that source code reviews have been
conducted as part of the development process. (See SOP_401 Code
Review SOP).

2.7 Unit (Component) Testing

The final step of the design phase of the system should be unit
testing. Unit testing should ensure that the components meet the
standards identified in the SDLC used. (See SOP_402 Unit Testing
SOP).

2.8 Validation Change Control Process

The change control process begins at the point of approval of the
user requirements specification. This is important to ensure that
traceability of requirements is maintained. (See SOP_0900
Validation Change Control SOP).
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3 Design Qualification - Phase Entry/Exit

3.1 Phase Entry

The entry point for the Design Qualification is the approval of the
User Requirements Specification or concept statement.

3.2 Phase Exit

The exit point for the Design Qualification phase of validation is the
approval of the Design Qualification Report.
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4 Design Qualification Protocol - Preparation

The Design Qualification Protocol describes the process to be
followed that will ensure the design and development of a computer
system does not compromise its validated status.
The audience for the DQ protocol will be business staff within the
company and industry regulators. Therefore, the document
wherever possible should be written in non-professional terms. The
DQ document must be able to be read in isolation and therefore
provide enough detail on the purpose of the system.
The Design Qualification Protocol must be created to conform to the
SOP_102 Documentation Standards SOP.
The following subsections provide a synopsis of the content of the
DQ protocol.

4.1 Protocol Title

Give the Protocol a descriptive title, which reflects the scope of
testing performed in the Protocol and provides sufficient
differentiation between this Protocol and other protocols for the
system.

4.2 Pre-approval
At the beginning of the DQ Protocol a pre-approval section is
required. This section will contain a table for signatures. The table
of signatures must provide for the following information to be
captured:
1. The department or function of the signatory;
2. The name of the signatory;
3. A space to record the signature, and;
4. A space to record the date of the signature.
The section must contain a statement informing the reviewer that
signing this document infers that they have read, understood and
agree with the contents of the protocol.
Normally this information is collected on the approval page of the
DQ Protocol.
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4.3 Introduction
The introduction section of the DQ protocol must contain
subsections providing information on:
1. The objectives of the DQ protocol;
2. The scope of the DQ protocol stating the phase of the
implementation lifecycle the IQ protocol applies too;
3. A list of documents referenced in the DQ protocol;
4. A description of the system being designed which identifies
the intended use of the system.

4.4 Regulatory Requirements

Details of the international regulatory requirements that apply to
the computer system being validated must be identified.

4.5 Methodologies
This section of the DQ protocol must identify any Software
Development Lifecycle or development methodology to be used in
the design and development of the system. This section must
describe any issues identified with this methodology and the
controls that have been put in place to address these issues.

4.6 Documents to be reviewed

This section must identify the document to be reviewed as part of
the DQ process. In addition, this section must identify any
documents that have been omitted or are to be omitted with an
explanation of the reasons for their omission.

4.7 Acceptance Criteria

List the criteria the system must meet to satisfy the objectives of
the DQ.
Acceptance Criteria must meet the following standards:
The Acceptance Criteria (AC) must be unambiguous,
measurable, and verifiable. Terms such as appropriate and
very are not acceptable in most functions.

Examples:
o Unacceptable AC: The Technical Design Specification
will contain appropriate definitions of code modules.
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o Acceptable AC: The Technical Design Specification will

contain detailed definitions of code modules
including...
o Unacceptable AC: A message will display when an
invalid quantity is entered.
o Acceptable AC: A message will display indicating entry
of an invalid quantity.
Number or uniquely label the Acceptance Criteria so they
may later be identified.
The Acceptance Criteria should have their basis in the user
requirement specification and relevant regulatory
requirements.
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5 Design Qualification Report

On completion of the Design Qualification process the Design
Qualification protocol is revised to include the following sections:
Report on the design evaluation process;
Summary and Conclusions, and;
Protocol Results Acceptance.
The inclusion of these sections in the DQ protocol and the
associated approval process of the revised DQ protocol will create
the Design Qualification Report (DQR).

5.1 Report on the design evaluation process

This section identifies:
The results of the evaluation of the identified design
documents against the user requirements, regulatory
requirements, and SDLC/QA processes;
Details of the change generated during the design
qualification process. See SOP_0900 Validation Change
Control SOP.

5.2 Summary and Conclusions

Provide a summary of the results of the design qualification process
and any encountered deviations. Problems encountered during
execution of protocols will be summarised according to: protocol
errors, execution errors, specification errors, and non-conformance
to regulatory requirements and requirements expressed in the user
requirements specification.

5.3 Protocol Results Acceptance

The last section of the DQ report must be the Protocol Results
Acceptance section. This section records the approval of the revised
DQ protocol that forms the DQR. This section will contain a table for
signatures. The table of signatures must provide for the following
information to be captured:
1. The department or function of the signatory;
2. The name of the signatory;
3. A space to record the signature, and;
4. A space to record the date of the signature.
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The section must contain a statement informing the reviewer that

signing this document infers that they have read, understood and
agree with the contents of the protocol.