ISO 9001 : 2008

BUILDING MANAGEMENT SYSTEMS

21 CFR Part 11 Compliant Systems for Lifesciences & Healthcare Industry

Integrated Building Management Systems

www.gmptech.net

An Emerging Leader

IBMS

GMP Technical Solutions is an emerging leader in

GMPs Building Systems business specialises in providing integrated

IBMS Technologies that enables utility and industry

solutions for pharmaceuticals, biotech and healthcare building

customers to improve performance while lowering

facilities encompassing monitor & control of temperature, relative

environmental impact. The GMP group of

humidity, pressure differentials, indoor air quality, airborne

companies has a pan India presence and employ

particulate count (for ISO classified areas) Building Management

over 500 people. GMP serves its customers with

Systems based on open protocols like Lonworks, BACnet, Modbus

complete range of IBMS technologies. The company

along with the 21 CFR Part 11 compliant software and documentation

has a good installation base and has a countrywide

as per GAMP ensures facility managers are ready for audits of USFDA ,
MHRA, MCC, MCA, TGA. As an engineering solutions provider GMP

marketing and service presence.

takes responsibility for design, supply, installation, commissioning

and maintenance, offering end-to-end solutions, energy
management /conservation and comfort throughout the life-cycle of
the building.

Building
Automation System
Fire
Detection
and Smoke
Control

Access
Control

CC TV
MATV

PLC &
SCADA

Evacuation
System

Lighting
controls
& EIB

Tenant
Billing

PA &
BGM

IT &
Communication
Infrastructure

Parking &
Visitor
Managment

Integrated Building Management Systems (IBMS)

Integrated Building
Solutions
Electrical
(External & Internal)

Power &
Control
Cables

Back - up
Power
(DG+UPS)
Surge
Protection

Distribution
Boards

Electrical
Wiring
Accessories

Power
Energy
Quality
Management
Improvement

Indoor Climate
Solution

Energy
Saving

Sub
Station with
RMU & CSS
Line
Protection
Devices

Earthing
Systems

Lightening
Protection

Power Distribution and Management

Ventilation
Systems &
CO Control

Clean Rooms

VAV
Systems

VRV
Systems

Contamination
& Odour
Control

Noise
Control

Temperature &
Humidity Control

HVAC & Cleanroom

Differential
Pressure
Control

Integrated Building Management Systems

www.gmptech.net

BMS in Lifesciences and Healthcare Industry

GMP designs and engineers complete automation of the air-conditioning and ventilation systems including supply, erection
and commissioning, which helps monitor & control critical parameters like temperature, relative humidity, pressure
differentials, cleanliness & carbon dioxide. State-of-the-art clean room technology ensures contamination control - a critical
requirement for pharmaceutical, biotechnology and healthcare. Together with energy management / conservation and
security systems seamlessly integrated with web based building automation; our solutions are designed for facilities to
function smoothly & efficiently.

Sterile

Laboratories

Wards

Operation Theatres

Control & monitor of

Monitoring of

Individual lighting control

Customised Operation

critical parameters like

environment parameters

temperature and demand

Theatre Solutions & Clean

Temperature

like temperature,

driven ventilation need to

Room Technologies

Relative Humidity

humidity and differential

suit varying patient &

Differential Pressure
Airborne Particulate
Count
CO2 Levels

pressure for critical

personnel requirements

an
rm
rfo
Pe

Size

ce

studies

Functionality
Control of pressure
regimes

Close control of
Temp/RH

Air cleanliness &

Cross contamination/
quick removal of dust air particulate content

Documentation,
Validation

Integrated Building Management Systems

www.gmptech.net

Open Systems - Freedom to all

GMP's open architecture offers immense integration possibilities and complies with internet and web standards offering full
flexibility to communicate with any computer via the world wide web (www). This allows the user to view the entire system on
a single screen shot facilitating effective and convenient monitoring and control of all systems simultaneously from a remote
location at the click of a mouse. Software is compliant to the USFDA 21 CFR Part 11 norms and can be used to easily integrate all
the systems on Lonworks, BACnet, Modbus RS232/485 etc.

Basic Functions
Equipment scheduling (operating equipment as
required)
Optimum start / stop (running of HVAC equipment
only during occupancy)
Operator adjustment (accessing of set point to tune
the system)
Monitoring (logging of temperature, trends,
equipment start & run time, operator log on etc.)
Alarm reporting (notify failed equipment, out of limit
temperature / pressure)
Provide status of specialised system like SCADA, lighting
control, load management, access control, etc

Typical System Architecture

Enterprise System

Web Browser

Cell
Phone

Web Browser

PDA
Server

XML/SOAP

HTML/HTTP

BACnet /IP,
To
Third Party
Equipment

WML/WAP

100Base-T Ethernet

WML/WAP

HTML/HTTP

Internet

LGR Router
or ME-LGR
Router/Controller

Ethernet, ARCNET, EIA-485, EIA-232

ME 812u-E
Controller

BACnet MS/TP, ARCNET

ME line
Controller

SE line
Controller

Room Sensor
RS Standard
Room sensor

Room Sensor

ZN line
Controller

Room Sensor

Room
Controller

Integrated Building Management Systems

www.gmptech.net

Scalable, Modular & Flexible BMS Solutions

GMP Building Management Systems provide Control, Monitoring and
Alarming of a range of environmental parameters like temperature, relative
humidity, pressure differentials & air borne particle count. These solutions are
modular and scalable and can be used for a single room to plant wide
applications.
They are ideal for :
Implementing new system
Enhancing existing systems
It offers the options for :
Centralised BMS
Network of local stand alone BMS units
Combination of centralised and local systems to increase
availability and ease of use

Sensor
Sensors communicate measurement & status information
from the process to the control & monitoring modules of
the BMS system.
Sensors include :
Temperature
Relative Humidity
Air Pressure or Differential pressures
Luminescence (light level)
Particle counters
Air Flow patterns
Gas Level
Noise
Water Leak Detection
Door Status
Fire Detectors
HVAC healthy status
For hazardous rooms intrinsically safe devices must be
used including :
Intrinsically Safe Sensors
Intrinsically Safe Barriers
Intrinsically Safe IO modules

GMP can offer a range of the above sensors or alternatively provide interface to sensors provided by
the user.

Integrated Building Management Systems

www.gmptech.net

Data Logging and Audit Trail Designed to Satisfy 21 CFR Part 11

Data logging
Data logging is a key requirement for BMS Systems. 21 CFR

The BMS system offers provisions for electronically

Part 11 requires that logged data will be tamper proof and

copying data for archive and export facility to common

will include critical environmental parameters

packages (e.g. Excel, PDF, Word etc.) for viewing of secure

(temperature, humidity, pressure, particulate, sizes etc),

records in human readable format. Other features of the

with audit trails including:

system includes :

Accurate time and date stamps

Power and network recovery automatic

Alarms and events

User actions and details (e.g. Set point changes)

procedures
FTP server to put the data on a central server

User notes

Scheduled transfers

Login/ Logout

The system can be configured to provide logging for non-

BMS log plant data to tamper proof files and SQL relational

critical parameters including;

databases.

System events

Data logging can be offered as:

Equipment failure

Local logging (Tamper proof file)

Equipment performance and maintenance

Central logging (SQL database)

Energy usage

Local and central logging (Tamper proof files and S Q L

Security Manager

database)

Security Manger offers significant operation cost savings

The availability of logged data can be significantly

and ease of use by allowing maintenance of user

increased by the local and central logging option. This

accounts and passwords from one or multiple locations.

allows data collection in multiple devices to further protect

If a user needs to change their password they can do so

vital plant data.

on a local instrument or PC and this will be automatically

Typically a BMS system comprise of a number of

distributed across all systems to which they have access.

distributed units where each unit has its own internal clock.

A common security tool across multiple product

Time synchronisation is included to ensure accurate time

ranges

and date stamps as required by 21 CFR Part 11 to a known

Change in one place, deploy to many

clock source

Support for multiple security zones

Built-in audit trail for 21 CFR part 11 validation
Automatic version control
Support for electronic signatures

Integrated Building Management Systems

Alarms and Events Reporting

An important feature of the BMS is its Alarms and Events
functionality. All alarms and events are time stamped and
logged for long term retention and validation to 21 CFR Part
11. Individual plant data can be configured to have one or a
combination of the following alarms:
Absolute alarms
Deviation alarms
Rate of Change alarms
Delayed alarms
Excursion alarms
Alarms can be configured as critical, non-critical or as an
event. Critical alarms will require manual acknowledgement
and non-critical will be auto-acknowledged. Alarm selection
and set point settings are available to the users with the
appropriate access level and critical alarms can be
configured to require an Electronic Signature for changes.
Alarm acknowledgement and all changes to alarm settings
are automatically logged as required by 21 CFR Part 11.
All alarms and events are reported through local, central,
and remote HMI panels. They are displayed in the Alarm
Summary and Alarm History pages that provide a sort facility
for the information. Alarms can be grouped by their
criticality and function to ensure individual alarms can be
quickly accessed.
Other features of the BMS alarm system include:
Audible alarm notification
Notification of alarm conditions to designated users on a
designated telephone number
Local printing alarms events

www.gmptech.net

Integrated Building Management Systems

www.gmptech.net

Accurate Control
Monitoring

Control

BMS offers a wide range of options for monitoring the

It offers standard control functionality, e.g. PID loops, to

plant. Information can be monitored locally, centrally and

accurately control the various environmental conditions of

remotely. Access to the system is protected. Users must

the room.

login to gain access to functionality, defined by their access

It also provides the functionality required to control

level.

devices such as pumps, motors and valves, e.g. start/stop

Plant information is monitored through standard and

with necessary interlocks. Operation can be configured to

custom displays and includes :

be automatic, semi-automatic, manual or any combination

Live data

of these.

Mimics with live data

Individual room/areas may be operated in different modes;

Multi language support

the selection of which is access controlled by authorised

Information received from the plant is grouped together in

users:

various forms to allow the users to rapidly access the

In operation: Automatic control of critical parameters

required information. The system utilises an easy to use,

Maintenance: Automatic and Manual control of critical

hierarchical methodology of presenting the necessary

parameters. This mode is also used for calibration of

information to the users including :

sensors.

Plant overview

BMS offers the facility for adjusting control parameters

Area Overview

(e.g. set points, alarm limits, tolerances and time delays) in

Individual room overview

order to achieve the desired condition in each room. This

Individual control loop view

feature is only available to users with the appropriate

Individual sensor overview

access permissions. The system provides a full audit trail of

Grouping by type (e.g. temperature, humidity, pressure)

these changes including electronic signatures.

Data collected from the plant are linked together and

displayed as trends using online and historical trending
within the system. Trended data are available in various
groups e.g. by room, by type (temperature, pressure etc.)
The monitoring facility also provides the user with access
to standard features of the system according to their
access level, access control with password protection for
individual user accounts, inactivity timeout and password
expiry, including :
Alarms
Trends
Alarm set point configuration
Control parameter configuration
Calibration facilities
Maintenance facilities
Batch displays
Electronic signatures
Configuration utilities

Integrated Building Management Systems

www.gmptech.net

Easy to Use, Comprehensive Reporting

Review and Reporting
BMS provides a comprehensive review and reporting

Information can be automatically transferred and accessed

system. The system offers two methods for collecting data:

from standard Microsoft Office packages.

Local data collection - Data collected locally in a secure

Realtime and historical trends

format and archived centrally in a filing system

Multiple data plots

Central data collection - Data collected in a central

Search by batch or by room

historical SQL relational database

Batch trend analysis

These methods may be combined and, in both cases, the

Golden Batch analysis

system provides the facility to create reports for individual

Standard and custom SQL queries

rooms. A number of standard report templates are

Direct insertion to ExcelTM, WordTM

provided along with the facility for users to create their

Quick report generation with standard templates

own reports.

Integrated Building Management Systems

www.gmptech.net

Validation as per GAMP

Why BMS

Documentation

Where environmental conditions could reasonably be

Validation documentation needs to be provided through

expected to have an adverse effect on product quality,

the life cycle of the BMS system. GMP can offer a range of

the manufacturer shall establish and maintain procedures

documentation services following GAMP guidelines and in

to adequately control these environmental conditions.

accordance with customer requirements;

Environmental control system(s) shall be periodically

User requirement Specification

inspected to verify that the system, including necessary

Functional Specification

equipment, is adequate and functioning properly. These

Design Specification

activities shall be documented and reviewed. FDA 21 CFR

Hardware testing

Part 820.70 Production and Process Controls, section c.

Code Review

Validation

Factory Acceptance test

A key requirement for BMS solutions is validation. Where

Installation Qualification

environmental conditions (e.g. Temperature, humidity,

Operational Qualification

differential pressure, air flow, sterility, containment) have

Periodic review

a direct impact on product purity, safety, quality or efficacy

SYSTEM DESIGN SPECIFICATIONS

they need to be monitored against predetermined limits

SYSTEM TEST SPECIFICATIONS

PQ Test Plan

USER REQUIREMENTS

PERFORMANCE
QUALIFICATION

and logged. In this case the BMS system used for collecting
and logging the data needs to be validated. According to

OQ Test Plan

FUNCTIONAL DESIGN

ISPE guidelines, it is good practice to monitor the

DETAILED DESIGN

performance of equipment such as fans, coil and control

components, but it is not a regulatory requirement.

IQ Test
Plan

OPERATIONAL
QUALIFICATION

INSTALLATION
QUALIFICATION

IMPLEMENTATION

GMPs validation approach helps all pharmaceutical environment managers keep

their records as per ISO regulations and USFDA regulated 21 CFR PART 11 compliance

BMS PROJECT CYCLE

USER

SUPPLIER
User Audit of Supplier
User Initiates

Master Validation Plan

Equipment Validation Plan
Explanation to Supplier
(Living Document)
User Requirements (URS)
Specification

RFQ

RFQ

Proposal
Quality Plan
Project Plan

sa

o
op

Pr

Functional Specification
(Traceable to URS)

P.O.
Proposal Analysis

Approval
Review Functional Specification

Review Detailed Design

Review System
Acceptance Test Specifications

Integrate with Validation

Documentation (as appropriate)

Approva

Detailed Design Documentation

(Traceable to Functional Specification)

System Acceptance Test

Specifications (IQ/OQ)
Hardware
Software

Approva

System Acceptance Testing and Results

(User Witness Optional)

Maintenance & Support

Documentation

Integrated Building Management Systems

www.gmptech.net

Total Lifecycle Support

Remote Alarm Notification

Services

Nominated users can be quickly notified of alarm conditions

GMP offers a complete range of services such as:

via the telephone system.

Expertise to assist with the user requirement

The system offers :

Specification

Real-time alarm notification triggered from the plant

system

Project, Application and Validation engineering

Commissioning (e.g. Calibration) and Qualification

Ensured delivery of the messages

engineering

Easy to configure tools

Training courses covering Products, Control theory,

Login facilities and security patterns

Validation etc.

Redundancy options

Helpdesk and On call services

Services need to be provided from the beginning of the

Product services

PE

RM

RESPONS

FO

project, through the project development and

ANCE

LAN
ME
ET I

Radios
Telephones

PCS and GSM

E-mail
Phone

LIF

Approved off-the-shelf
voice modem

Multimedia
speaker
or intercom
systems

Numeric Alphanumeric
pagers
Pagers

Cellular Phones

GMP Advantage
Advantages of GMPs BMS Projects methodology

Flexibility in maintaining clean environment

Concept to Commissioning

Documentation as per requirement of International

Design, Build & Validate

In-depth knowledge of the subject
Project management in a timely manner
Good Team Strength to handle customer
requirements at various stages of the project
Trained & Certified engineers by OEMs
Experience of Pharmaceutical projects
Validation know how as per cGMP, GAMP etc

Auditing agencies like MHRA, TGA, MCC, MCA &

USFDA
Updated with the latest technology means you get
the best available in the market
Turnkey Solutions at a single point
Building Management Systems based on open
protocols of BACnet, LONworks, MODBUS TCP/IP,
RS232/485, Ethernet.

Technology Partners
IP Based CCTV Systems

Access Control Systems

Fire Detection and Alarm System

Fire Suppression System

Public Address System

Smoke Aspiration System

Building Automation System

Contamination Control Products

Our Esteemed Clientle

ISO 9001 : 2008

Registered Office

GMP Technical Solutions Private Limited

309-316, 3rd Floor, Swastik Disa Business Park,
Behind Wadhani Industrial Estate, L.B.S. Marg,
Ghatkopar (W), Mumbai - 400 086, Maharashtra, INDIA
Tel : +91 22 66083700 Fax : +91 22 66083737
Email : enquiry@gmptech.net
Website : www.gmpcleanrooms.com, www.gmptech.net
Manufacturing Facility
Gunia Road Mandhala, Via Barotiwala,
Kasauli, Dist. Solan, H.P. - 174103, INDIA.
Tel : +91 1792 253101

Hyderabad
2nd Floor, Patel Trade World,
Karbala Maidan, Off. M.G.Road,
Behind Hotel Moksha,
Secunderabad - 500 003
Goa
Plot - L - 73, Behind Betts India Pvt. Ltd.,
Verna Industrial Estate, Verna Salcette,
Goa - 403722
Bangalore
1st Floor, 365, 38th Cross, 9th Block,
Jayanagar, Bangalore - 560069

Ahmedabad
D-43, Konark Krishna,
Opp. Renuka Hall,
Vastrapur, Ahmedabad - 380015
Noida
RS-1/3, 2nd Floor, Savitri Market,
Sector 18, Noida (U. P) - 210 310
Pune
2nd floor, Vascon Almonte Building,
Near Radisson Hotel,
Kharadi-Hadapsar Bypass Road,
Yashwant Nagar Chowk,
Kharadi, Pune - 411014