Installation Qualification Template

1. Introduction
1.1. Objectives
The objective of Installation Qualification (IQ) testing is to demonstrate that the
solution is installable under normal expected conditions with acceptable and
expected output results.
1.2. Scope
IQ testing involves deploying the solution in scenarios that are defined in the Nymi
Design/Configuration Specifications document.
1.3. Assumptions
• A reliable network connection exists between each component in the
environment.
• The tester has access to Nymi Enterprise Edition documentation.
1.4. Exclusions

2. Acronyms and References

2.1. Acronyms and Definitions

Acronyms and Definitions

AC Acceptance Criteria

CFR Code of Federal (US) Regulations

Abbreviation which includes current Good
cGxP
Manufacturing, Clinical and Laboratory Practices
CS Configuration Specification

CSV Computer Systems Validation

DS Design Specification

FS Functional Specification

GUI Graphical User Interface

IQ Installation Qualification

LAN Local Area Network

OQ Operational Qualification

1
 PQ Performance Qualification

SOP Standard Operating Procedure

URS User Requirements Specification

2.2. References
References

21 CFR Part 11, Part 210

GAMP5 Guide for Validation of Automated Systems

URS URS for Biometric MES System

FS NYMI FS-001

DS/CS NYMI CS-001

3. Responsibilities
3.1. System Owner
To provide all required documentation, create the performance qualification testing
document, and to provide a functional test environment.
3.2. System Validation Tester
To perform the qualification testing and record the results in this document.
Documenting any issues that are encountered.

4. System Description
NES and AD servers reside in the same domain as do the user terminals. The
configuration falls into GAMP5 Category 3.

5. Test Procedure
5.1. General

System Name: nes.domain.com

Test Title: Installation Qualification of NEE 3.3

Purpose: Verify that the solution is installable in a virtual IT Infrastructure

2
 Test Reference: IQ-001 Test Run #: 01

Tester name: Execution Date:

URS tested: URS-001, URS-002

Functional Specification: FS-CFG-001, FS-CFG-010

Environment details: NES and AD server reside in the same domain and are hosted on virtual
Windows 2016 servers
Step# Procedure Expected Result Actual Result Pass/Fail

NEE component deployments:

Supported configuration AD configured,
Satisfy prerequisite is in place and Windows server in
1 Pass
requirements. certificates have been place, certificates
obtained. obtained
Install IIS and IIS installation
IIS installation completes
2 ASP.NET, as completed Pass
without error.
documented. successfully.
Import the TLS
certificate, as TLS certificate import Certificate imported
3 Pass
documented. succeeds without error. without error.

HTTP bindings are

Add HTTPS bindings in HTTP bindings
4 created by using the TLS Pass
IIS, as documented. created successfully.
certificate.

Create the CRL

Directory creation
5 directory, as Directory is created. Pass
succeeds.
documented.

Import and configure the Fullchain certificate Full chain imported

6 certificates, as import and configuration and configured Pass
documented. completes without error. successfully.
Installation process
Install the NES software Prerequisite software
installs the prerequisite
7 using the wizard, as installation completed PASS
software and the NES
documented. without errors.
software without error.

3
 Configure NES with NTS NES configuration NES configuration
8 PASS
as documented. completes without error. with NTS completed.

System Name: nes.domain.com

Test Title: Installation Qualification of NEE 3.2.1

Purpose: Verify that the NES is installable in a multidomain/multiforest environment.

Test Reference: IQ-002 Test Run #: 01

Tester name: Execution Date:

URS tested: URS-003

Functional Specification: FS-CFG-03, FS-CFG-04
Step# Procedure Expected Result Actual Result Pass/Fail
NEE component deployments: (Follow NEE
Deployment Guide):
Supported configuration AD configured,
Satisfy prerequisite is in place and Windows server in
1 Pass
requirements. certificates have been place, certificates
obtained. obtained
Install IIS and IIS installation
IIS installation completes
2 ASP.NET, as completed Pass
without error.
documented. successfully.
Import the TLS
certificate, as TLS certificate import Certificate imported
3 Pass
documented. succeeds without error. without error.

HTTP bindings are

Add HTTPS bindings in HTTP bindings
4 created by using the TLS Pass
IIS, as documented. created successfully.
certificate.

4
 Create the CRL
Directory creation
5 directory, as Directory is created. Pass
succeeds.
documented.

Import and configure the
6 certificates, as
documented.
Install the NES software
7 using the wizard, as
documented.
Configure NES with
8 multiple domains as
documented.
Full chain certificate Full chain imported
import and configuration and configured Pass
completes without error. successfully.
Installation process
Prerequisite software
installs the prerequisite
installation completed Pass
software and the NES
without errors.
software without error.
NES configuration
NES configuration
with multiple domains Pass
completes without error.
completed.

System Name: nes.domain.com

Test Title: Installation Qualification of NEE 3.2.1 HA

Purpose: Verify that the solution supports high availability

Test Reference: IQ-003 Test Run #: 01

Tester name: Execution Date:

URS tested: URS-029

Functional Specification: FS-CFG-002
Step# Procedure Expected Result Actual Result Pass/Fail
Review the High
High Availability
Availability Architecture in Documentation is
1 Architecture is specified Pass
the Nymi Deployment reviewed.
in the guide.
Guide.
Configure load balancers Load balance is
Load balance
2 for high availability successfully Pass
configuration succeeds.
deployment. configured.

5
 Perform SQL Database SQL database is
3 configuration for High Configuration succeeds. successfully Pass
Availability. configured.