USER REQUIREMENTS SPECIFICATION (URS)

FOR
ONLINE TEMPERATURE, RH AND ALARM, DATA LOGGING &
EMAIL ALERT SYSTEM

SOFTWARE NAME : “SIMATIC WinCC V7.5”

TEST FACILITY

BIONEEDS INDIA PRIVATE LIMITED

DEVARAHOSAHALLY
SOMPURA HOBLI, NELAMANGALA TALUK
BANGALORE RURAL DISTRICT, PIN – 562 111
KARNATAKA, INDIA
E-mail: bioneeds@[Link]
Website: [Link]
Tel No.: +91 816 – 2214400
Fax: +91 816 – 2214444

Role Name & Designation Sign & Date

Mr. Shivananda Murthy M. V.

Prepared by
Head- Information Technology

Ms. Mamatha M. B.
QAU Review
Head- Quality Assurance Unit

Approved by Dr. Mallikarjun Narayan Dixit

Management Deputy Test Facility Management
Reference: Enclosure No. 6A of SOP No. BIO-IT-001, Version No. 05

Page: 1 of 15
 Table of Contents
1. OBJECTIVE ..................................................................................................................................3
2. PURPOSE......................................................................................................................................3
3. RESPONSIBILITIES ....................................................................................................................4
4. INTRODUCTION .........................................................................................................................4
5. CURRENT SYSTEM ....................................................................................................................4
6. PROCESS OVERVIEW................................................................................................................4
7. SYSTEM OBJECTIVE .................................................................................................................5
7.1 Infrastructure Requirements (Minimum Requirements) ......................................... 5
8. MODES OF OPERATION & OPERATIONAL REQUIREMENTS ...........................................5
8.1 Modes of Operation ................................................................................................. 5
8.2 Functional Operation ............................................................................................... 5
8.3 Operator Interfaces .................................................................................................. 6
8.4 Report Outputs......................................................................................................... 6
8.5 Data Archiving ........................................................................................................ 6
8.6 System Operational Tests ........................................................................................ 6
8.7 Functional Requirement .......................................................................................... 7
8.8 Security Requirement .............................................................................................. 7
8.9 Data Requirement .................................................................................................... 8
8.10 Audit Trail Requirement.......................................................................................... 8
8.11 Electronic Signature Requirement ......................................................................... 10
8.12 Interface Requirement ........................................................................................... 10
8.13 Reporting Requirement ......................................................................................... 11
9. PROPOSED SOLUTION ARCHITECHTURE..........................................................................12
9.1 Ground Floor: Alarm panel installed location identification ................................ 12
9.2 Second Floor: Temperature sensors & Data logger installed location identification
............................................................................................................................... 12
9.3 Third Floor: Temperature sensors & Data logger installed location identification
............................................................................................................................... 13
10. SAFETY FEATURES .................................................................................................................13
11. ENVIRONMENTAL CONDITIONS .........................................................................................13
12. SERVICE CAPABILITIES .........................................................................................................13
13. OTHER ATTRIBUTES ..............................................................................................................14
14. DOCUMENTATION ..................................................................................................................14
15. TESTING ....................................................................................................................................14
16. TIME SCALE/DELIVERY .........................................................................................................15
17. GLOSSARY ................................................................................................................................15

URS: BMS Page: 2 of 15

 USER REQUIREMENT SPECIFICATION
FOR
ONLINE TEMPERATURE, RH AND ALARM, DATA LOGGING &
EMAIL ALERT SYSTEM

1. OBJECTIVE

The objective of this Simatic WinCC V7.5 software is a web-based user interface for
managing online temperature, RH and alarm, data logging and email alert system.
Simatic WinCC V7.5 is a supervisory control and data acquisition (SCADA) and human-
machine interface (HMI) system from Siemens. SCADA systems are used to monitor and
control physical processes involved in industry and infrastructure on a large scale and
over long distances. Simatic WinCC can be used in combination with Siemens
controllers.

2. PURPOSE

The purpose of this User Requirement Specification for Centralized system for online
temperature, RH and alarm, data logging & email alert system.
• Monitor the proper functioning of the SCADA
• Test for the Logging of the Data from respective sensors.
• Test for transferring of data from the IO panel to a SCADA PC.
• Reading of the transferred data, from the IO panel to a SCADA PC on the “Siemens
SCADA” Software.
• Visual and E-mail Alert on any Excursions.

In order to meet the business needs of the users, URS includes the following but not
limited to:

• Operational Requirements
• Functional Requirements
• Hardware Requirements
• Security Requirements
• Data Requirements
• Audit Trail Requirements
• Electronic Signature Requirements
• Interface Requirements
• Reporting Requirement
• Regulatory Requirements

URS: BMS Page: 3 of 15

 • Any other Requirements not defined above

3. RESPONSIBILITIES

The personnel working in GLP system, Management, Quality Assurance Unit (QAU)
personnel, Information Technology (IT) and Maintenance teams are responsible for
implementation of this software.

4. INTRODUCTION

The Simatic WinCC V7.5 software is a set of processes and procedures required for
monitoring and recording of online temperature, RH of user set-limits. Also, with email
alert and alarm system in case of any deviations in the temperature and RH at Bioneeds
and maintenance of these records are as per OECD GLP regulations.

5. CURRENT SYSTEM

Manual procedure (i.e., paper-based records) with the aid of digital thermohydrometer
adopted at Bioneeds for monitoring and recording of temperature and RH for the required
components in GLP system.

6. PROCESS OVERVIEW

With the increasing demanding regulatory requirement for compliance vis-à-vis the rapid
pace of organization growth, managing and recording temperature and RH processes
becomes cumbersome. Lots of documents are generated across sites and monitoring of
these related records becomes both resource and time consuming. So, requirement arises
for centralized automated Building Management System (BMS) software which shall
cater all these requirements with better control in place. The BMS i.e., Simatic WinCC
V7.5 provide an online compliant with features of online recording and monitoring of
temperature and RH in addition to data logging, alarm and email alert system for any
deviations in the recorded temperature.

URS: BMS Page: 4 of 15

7. SYSTEM OBJECTIVE

7.1 Infrastructure Requirements (Minimum Requirements)

a) Configuration for Production Server Specification

i. Server Hardware Specification
CPU 8 Core or Higher
RAM 24 GB or Higher
HDD 1 TB SSD disk or Higher
ii. Server Software Specification
Operating System Windows Server
Database MySQL
Server Apache Tomcat Server
iii. Network Bandwidth
Network 2 MBPS upload speed per user
Connectivity 1 MBPS download
b) Specification for Client (User) Computer
Dual core or higher
Configuration Windows XP SP3 or higher
1 GB or higher
User Interaction Google Chrome
(Browser (Version 49.0 or higher)
Compatibility)
Server Apache Tomcat Server
Network TIMS server network connection is
Connectivity mandatory (min. bandwidth 2 Mbps)

8. MODES OF OPERATION & OPERATIONAL REQUIREMENTS

8.1 Modes of Operation

• The individual sensor connected to the specific location and common junction
box.
• Each junction box as related to Static IP and connected through Local LAN
network
• Visual and email alert on any excursions.

8.2 Functional Operation

• Monitor the proper functioning of the SCADA

• Test for the Logging of the Data from respective sensors.

URS: BMS Page: 5 of 15

 • Test for transferring of data from the IO panel to a SCADA PC.
• Reading of the transferred data, from the IO panel to a SCADA PC on the
“Siemens SCADA” Software.
• Visual and E-mail Alert on any Excursions.

8.3 Operator Interfaces

• Configuring the 21CFR Security options on the SCADA software.

• User ID and password will be provided department wise to retrieve the data.
• Configuring the IO with respect to the input cards inserted in the IO panel.
• Placing the IO Cards at a desired location.
• Test to Start and stop the logging.
• Test to dump the date on an via Ethernet onto the PC.
• Test the transferring of the date from the “Siemens SCADA” Software installed
on the PC.

8.4 Report Outputs

• Detail hard copy printed reports required from the system, if required.
• Recorded data and alarm data are stored in soft copy formats.

8.5 Data Archiving

• The data will be stored in the database in specified path.

8.6 System Operational Tests

Requirement Requirement
Reference
UR-8.6.1 Check the Calibration Status of Components used

UR-8.6.2 “Siemens SCADA Software”

UR-8.6.3 CFR21 Enabling

UR-8.6.4 Identification of the Inputs connected

UR-8.6.5 Set Alarm Limits

UR-8.6.6 IO Panel Placement

UR-8.6.7 Data Dumping

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 Requirement Requirement
Reference
UR-8.6.8 Report Generation

UR-8.6.9 Data Modification

UR-8.6.10 Check the Calibration Status of Components used

8.7 Functional Requirement

Requirement
Category Requirement
Reference
General The format for date must be DD-MM-YYYY
UR-8.7.1 and time format shall be HH:MM as per
requirement
requirement.
The software shall be capable to generate
UR-8.7.2 message for errors that occur during the
process such as communication error etc
UR-8.7.3 The software must not allow tampering of
Notification error message.
Software shall have provision of automatic
e-mail notifications as per below
UR-8.7.4 requirements but not limited to:
• Temperature deviation
• RH deviation
Restriction Software must be accessible to open in web
UR-8.7.5 browser e.g. chrome, etc.
criteria

8.8 Security Requirement

Requirement Requirement
Category
Reference
System must have a security mechanism that
UR-8.8.1 uses at least two distinct identification
components (e.g., User ID/ password) or
biometrics.
The system must lock the user session
after a specified number of minutes of
UR-8.8.2 inactivity by requiring that the user re-enter
User ID
their User ID and password to continue the
Requirements
user session
System shall have configuration option to
UR-8.8.3
adopt active directory policies
System shall not allow to delete the account
UR-8.8.4 once created in the system. System shall
allow deactivating the user account if user no

URS: BMS Page: 7 of 15

 Requirement Requirement
Category
Reference
longer exists in the system or that account is
not required in the future. However, this
right shall remain with the Administrator
The system must have role/activity-
UR-8.8.5
based configuration
User Role/ The system shall provide capability
Authorisation for the configuration of different access
Control UR-8.8.6
privileges for the different types of user
groups.
The system shall allow to add single user ID
UR-8.8.7
in multiple system roles.

8.9 Data Requirement

Requirement Requirement
Category
Reference
UR-8.9.1 Electronic data and reports must be in
Data human readable date and time stamped.
Requirement Software shall have the facility for auto data
UR-8.9.2
back-up to any client or connected central
server.
UR-8.9.3 The system shall support the acquisition of
date and time from server
Data Input System shall have capability to manage
UR-8.9.4
addition of metadata for future
implementation
The system shall support manual as well as
auto backup.
UR-8.9.5
The software shall have the facility for
Data backup automatic data backup to any client or
restore and connected central server.
Archiving The system shall allow recovery/restore
UR-8.9.6
functions for generated electronic data along
with audit trail data
UR-8.9.7 Backup files shall be stored in secure server

8.10 Audit Trail Requirement

Requirement Requirement
Category
Reference
UR-8.10.1 Software shall track for all modifications,
audit trail and deletions performed with

URS: BMS Page: 8 of 15

 Requirement Requirement
Category
Reference
reason and date and time stamped along with
user details.
UR-8.10.2 The software shall automatically record
Audit Trail unauthorized login attempts.
Audit trail function must be always ON (by
UR-8.10.3
default), and impossible to disable the audit
trail function.
Audit trail documentation shall be retained
UR-8.10.4
for a period, and it shall be available for
review if required.
UR-8.10.5 Archive records shall be retrievable.

UR-8.10.6 Predefined and configurable filters shall be

available to view the audit trail.
The system audit trail must track the creation,
modification, deletion of records and
Updating records including the following
a. Identity of the person making the
change
b. Action that creates, modify/ change
UR-8.10.7
and/or delete a record
c. Time and date that the change was
affected
d. Reason for modification/change to a
record Changes made may not
obscure old information.
Audit Trail
The audit trail must be searchable,
transferable electronically and printable in
human readable format.
System must have provision for secure,
computer- generated, time-stamped audit
trail that records the date and time of operator
UR-8.10.8 entries and actions that create, modify, or
delete electronic records with reason
Prompt.
System shall track for all creations,
modifications and deletions performed in the
system (All activity shall be logged between
login and log out) with time and date stamp
along with user details.

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 Requirement Requirement
Category
Reference
The audit trail must always be "on", entries
UR-8.10.9
must be recorded automatically when a
transaction occurs.
The audit trail generation must be outside the
UR-8.10.10
control of and access of all users as well as
system administrators.
UR-8.10.11 The audit trail must be protected
from any modification/ deletion

8.11 Electronic Signature Requirement

Requirement Requirement
Category
Reference
UR-8.11.1 Each E-signature must be unique to one
individual.
UR-8.11.2 System shall have two components for the
execution of signature.
Electronic
Electronically signed records shall
Signature contain the Signature following information
UR-8.11.3 associated with the signing
• Full printed name of the signer
• Date and time of signing

8.12 Interface Requirement

Requirement Requirement
Category
Reference
System shall be interface with Active
UR-8.12.1
Directory (Domain) for User ID and
Interface Password Management.
Requirement UR-8.12.2 System shall be capable to integrate with
third party application.
UR-8.12.3 Integration with Bioneeds Microsoft
exchange server (email server).

URS: BMS Page: 10 of 15

8.13 Reporting Requirement

Requirement Requirement
Category
Reference
Required reports generated must contain date
UR-8.13.1
and time stamped along with user
identification.
The software shall be able to generate
the configurable reports as mentioned below
but not limited to:
UR-8.13.2
• Device-wise temperature & RH status
report
Reporting • Temperature & RH deviation report
Requirement
• Software shall allow to access active
users’ data only.
UR-8.13.3 • Software shall allow to access inactive
users’ data whenever required.

• Software shall have provision to

UR-8.13.4 download audit trail and reports in pdf,
.csv, .xls etc. format.

URS: BMS Page: 11 of 15

9. PROPOSED SOLUTION ARCHITECHTURE

9.1 Ground Floor: Alarm panel installed location identification

9.2 Second Floor: Temperature sensors & Data logger installed location identification

Temperature sensor Datalogger

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9.3 Third Floor: Temperature sensors & Data logger installed location identification

Temperature sensor Datalogger

10. SAFETY FEATURES

• Power Protection: Uninterruptible power supplies (UPS).

• Electrical Circuits and Distribution: Electrical distribution and sub-distribution
boards, breakers and cable connections, automatic transfer switches.
• Fire: Smoke detectors with alarm facility
• System should have compatibility with other integrated system within operational
requirements.
• System should comply 21CFR Part 11 requirements.

11. ENVIRONMENTAL CONDITIONS

• Environment Monitoring: Monitoring devices to measure temperature and

humidity.

12. SERVICE CAPABILITIES

• The vendor shall provide appropriate system licenses.

• AMC or SLA shall be available for continual from vendor as and when required.
• Supplier shall have development methodology of the system to meet current
regulatory requirements.
• Procedures shall be available with vendor for training management, and design
methods.
• System shall be validated with positive and negative testing as per approved
protocols.
• Support and maintenance shall be required after acceptance.
• Vendor shall support for any new feature updates and bug’s release.
• Vendor shall support in case of product discontinuity and major updates in product.

URS: BMS Page: 13 of 15

13. OTHER ATTRIBUTES

• Availability: required running time of the machine.

• Maintenance: The application must be available 24 hours a day, 7 days a week
(except during planned and unplanned network and/or system shutdowns).
• Training: Vendor shall provide Training to project team and /or to end users.
• Vendor shall provide Validation services such as Qualification documentations
such as:

o Carryout IQ/OQ/PQ documents with test evidence to prove the availability of

functionalities in the system being provided
o Function requirement document to be provided by vendor
o Configuration requirement to be provided by vendor

14. DOCUMENTATION

The vendor shall provide detailed documents delivered under the scope of the project
along with the User / Operational manual of the System. The details are as follows:

Sl. No. Description

1 Operational Manual & Service Manuals
2 Instrument Listing
3 Bill of Materials
4 Spare Part Lists
5 IQ, OQ & PQ Documents
6 Calibration Reports
7 Panel Assembly Wiring Diagram
8 Schematic Diagram

15. TESTING

The vendor shall perform IQ, OQ and PQ at Bioneeds site and provide procedure or
method for data backup, restoration and archival after successful qualification.

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16. TIME SCALE/DELIVERY

Expected time of completion of the Simatec WinCC V7.5 software latest by 3rd/4th week
of December 2022.

17. GLOSSARY

AMC : Annual Maintenance Contract

BMS : Building Management System
CFR : Code of Federal Regulations
GLP : Good Laboratory Practice
HMI : Human Machine Interface
IO : Input/Output
IQ : Installation Qualification
IT : Information Technology
LAN : Local Area Network
OECD : Organisation for Economic Co-operation and Development
OQ : Operational Qualification
PC : Personal Computer
PQ : Performance Qualification
QAU : Quality Assurance Unit
RAM : Random Access Memory
RH : Relative Humidity
SCADA : Supervisory Control and Data Acquisition
SLA : Service Level Agreement
SSD : Solid State Drive
UR : User Requirement
URS : User Requirement Specification

Reference: Enclosure No. 6A of SOP No. BIO-IT-001, Version:05

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