<TEMPLATE>

Corporate IT
Doc. No.: <Doc. No.> DESIGN AND CONFIGURATION
SPECIFICATION FOR <SOFTWARE
Supersedes: NAME>
<Supersede Doc. No./ Nil>

1.0 INTRODUCTION

1.1. Purpose

To define the purpose of Design and Configuration Specification for

<Software name>

1.2. Scope

<This section shall identify the design scope and business process to be
supported by the system and / or shall also identify the configuration of the
installed system.

Note: Sections or subsections in this template can be removed whenever not

required.

2.0 FUNCTIONAL DESIGN

2.1 Business Process Description

A brief design overview.

2.2 Pre-requisites

List out the pre-requisite for the development object.

2.3 Assumptions, Limitations and Dependencies

The assumptions, limitations and dependencies that apply to this

development specifications are as follows:
Assumptions, limitations and dependencies.

PREPARED BY REVIEWED BY APPROVED BY

SIGN & DATE

NAME
DESIGNATION
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00
 <TEMPLATE>
Corporate IT
DESIGN AND CONFIGURATION
Doc. No.: <Doc. No.>
SPECIFICATION FOR <SOFTWARE NAME>

2.4 Process Flows

Detailed Process Flow.

2.5 Processing Logic (for GAMP-5 Category Systems)

2.5.1 Selection Screen / Input Parameters

Selection screen fields.

2.5.2 Processing Logic / Pseudo code

Selection for Pseudo code.

2.5.3 Output Details

Sample report output format.

2.5.4 Audit and Error Handling Requirements

Sample report output format.

2.5.5 Other Specification

Include specifications other than those mentioned above.

3.0 TECHNICAL DESIGN (for GAMP-5 Category Systems)

3.1 Screen Layout

Screen Number Description

Field Dictionary Type / Checkbox/
Field Name Mandatory
Description Custom Type Radio button
C/R
C/R
C/R
C/R
Sample screenshot or layout of the screen

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 <TEMPLATE>
Corporate IT
DESIGN AND CONFIGURATION
Doc. No.: <Doc. No.>
SPECIFICATION FOR <SOFTWARE NAME>

3.2 Report Output Format

Field Field Dictionary Type /
Comments
Name Description Custom Type

3.3 Table Fields

Table Name Description
Field Domain/
Field Name Key Field Search Help
Description Custom Type

3.4 Other Objects

Include objects other than those mentioned above.

4.0 DETAILED DESIGN (for GAMP-5 Category Systems)

A detailed design / pseudo code to be filled up by the developer with comments.

5.0 ISSUES
List out the issues related to the development of the Design Specification.
Issue Found Description Person Status Issue
on Responsible Resolved on

6.0 CONFIGURATION DETAILS

System Type ☐ PLC ☐ HMI ☐ IPC ☐ Normal PC

Network Mode ☐ Standalone ☐ LAN Connected
Computer Name (In case of
Standalone)
Server Name (In case of Server
based)
Operating System
Instrument / Equipment Serial No.
Instrument Operation Procedure
Instrument / Equipment

Page 3 of 4 TMPLT-DCS-00
 <TEMPLATE>
Corporate IT
DESIGN AND CONFIGURATION
Doc. No.: <Doc. No.>
SPECIFICATION FOR <SOFTWARE NAME>

Qualification Report No. (if

applicable)
User Authentication Mode ☐ Local ☐ Lupin Domain (LDAP) ☐ Nil (Open
System)
Details (if Any):
User Privilege Matrix ☐ Yes ☐ No
Note: Attach draft /final privilege matrix copy
Raw Data Type ☐ ASCII Flat File ☐ Encrypted Flat File ☐ Local
Database ☐ Server Database ☐ No Data
Data Storage Path
Data Storage Capacity Limit
Audit Trail Feature ☐ Yes ☐ No
Audit Trail Storage Path
Audit Trail Entry / Log File Size
Limit
Alarm Audit Trail Path
Quality Risk Assessment Report
No (if available)
Back up Type
Backup Schedule
User Creation Procedure

7.0 ABBREVIATIONS:
<This section shall define any acronyms and key words used in the instruction.>
8.0 REFERENCES:
<Reference Document if any Ex: URS>
9.0 REVISION HISTORY:
Version No. Details of Review / Revision

TEMPLATE REVISION HISTORY

Version No. Details of Review / Revision

00 New Document
Note: Template revision history shall be removed while making the actual document.

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