Building Management System (BMS) –
Validation Overview
5 years ago
Building Management System (BMS) is a wide range of applications which covers Heating
Ventilation Air Conditioning (HVAC), Environmental monitoring, Fire Protection system,
Alarms & Surveillance System, Lift Management System, Smart Building Technologies and
Energy Conservations.
Why We Need to Validate a BMS?
The objective to conduct validation is to produce documents evident which ensure high
level of confidence, ensuring system compliance, reduce risk of failures, and assurance
that will improve operational efficiency to process. Validation is conducted to prove
system functionality and consistently measure as per design specification.
Building Monitoring System (BMS) covers computerize system, network architecture,
software as source code programming and instrumentations/ devices as controller
(Input/output) whereas it is monitoring for GMP elements and Non-GMP elements. As
parts of Code of Federal regulation, GMP elements/ critical areas are mandatory to
VALIDATE. There has to be segregation physically and logically between GMP and Non-
GMP elements to avoid conflict of I/O.
Regulatory Frame
EU Directive 2003/94/EC (Good Manufacturing Practice) – Article 8
“Premises and equipment to be used for manufacturing operations, which are critical to
the quality of the products, shall be subjected to appropriate qualification and
validation.”
Chapter 21 Part 11 Of the Code of Federal Regulation § 11.10 Controls for closed
systems.
“Validation of systems to ensure accuracy, reliability, consistent intended performance,
and the ability to discern invalid or altered records.”
Chapter 21 Part 211 of the Code of Federal Regulations § 211.68 Automatic,
mechanical, and electronic equipment.
“Input to and output from the computer or related system of formulas or other records
or data shall be checked for accuracy. The degree and frequency of input/output
verification shall be based on the complexity and reliability of the computer or related
system.”
System Evaluation
System evaluation is very crucial, evaluating the system against standards including GxP,
evaluating the system against established requirements, evaluating the needs of system
and environment configuration, evaluating the requirements for installation and training
requirements.
Risk Assessment
Risk Management should apply throughout life cycle of computer system. Identifies the
Critical Control Point to be defined, justified and documented. They key of risk
assessment is in understanding of critical parameters that have high probability of
affecting product attributes if deviate from ranges standard for a defined period of time.
Regulated Company must be able to justify their in-house standard, protocol, operation
procedures, and records, acceptance criteria based on analysis and risk assessment into
consideration.
Testing, Verification and Commissioning
Perform a commissioning procedure consisting of field I/O testing, sequential test phase
test and commissioning and integrated system program commissioning for entire
system.
Document all commissioning information on commissioning data sheets that shall be
submitted prior to acceptance testing.
Prior to system program commissioning, verify that each control panel has been
installed according to plans, specifications and approved shop drawings. Test, calibrate
and bring on line each control sensor and device.
Some of Tests have to be conduct before/ during Factory Acceptance Test and or Site
Acceptance Test, not limited to:
BMS Unit P&ID Verification
The objective of this verification is to ensure that all the system instrument and
equipment have been properly connected, tagged, and identified, in accordance with
the process and instrumentation diagram.
System Components Verification and Installation
The objective of this verification is to ensure that for each component required for the
system, all of the as-found conditions comply with the specifications, and that the
components required for this system are installed as specified.
Wiring and Cabling Verification
The objective of this verification is to ensure that all wiring and cabling to the system
has been properly connected, tagged, identified, and is in accordance with
manufacturers specifications and/or engineering drawings. During execution of this
section ensure that equipment visually checked to ensure that all component and wiring
securely mounted.
Input and Output Verification/ Test
The objective of this verification is to ensure that all input/output points are addressed
properly and connected to the field devices as per manufacturer specifications.
System Sequence Test/ Phase Test
The objective of this system sequence test/ phase test is to ensure that all system
schematic running as process flow which has been designed.
Software Functionality, Backup, Archiving, and Version
Verification
The objective of this verification is to determine that the installed software is perfectly
functioning as determined in this URS. Scope also includes verification of ladder logic
program name, version number, archiving capability and ensuring availability of the
backups.
Software Structure Verification
The objective of this verification is to verify integration of software and hardware as a
complete system. Scope includes system setups (hardware and software), to align with
user requirements. User would require full simulation and In Circuit Test for the BMS
System.
IT Infrastructure Verification
The objective of this verification is to verify integration of software, hardware and
networking as a complete system. Scope includes system setups, configuration of
network, remote accessibilities and remote notification.
Validation Approach
Perform a complete set of Validation after completion of Site Acceptance Test (SAT) for
the critical system which Direct Impact to the process quality.
Validation consist of Installation Qualification (P&ID check, instrument check, wiring
check, safety check and instruments calibration as well), Operational Qualification
consists of System Operational test verification comparing with Functional Specification
of the system as define in the System Design Specification.
Document all Validations and information on Validation data sheets that shall be
submitted prior to Validation testing.
Implementation of BMS
Nowadays, modern technology makes everything easily. Everything can be reach in
hand. Building Management System (BMS) using Real time monitoring will be displaying
process status, generate Reports (includes trends, graph), sensor calibration expiry,
generate alarm & warning according pre-set value in the system and event recording.
Perform the Facility Management (Generate reports, graph and annunciate alarms) when
there is a problem and to ensure that monitored data is securely stored and have not
been altered for future reference (audit/ investigation).
User/ client responsibility to provide proper procedure on the Data Recovery and
Software Back-up Procedure and manage the stored data location as per company
policy.
Defining of BMS Alarms
Correct strategy has to carefully implement to comply with regulatory requirements for
BMS system itself. During conducting Risk Assessment and measurement studies should
be assess for critical elements on the software features which derive as alarms,
reporting, data historical tabular in total point of view to avoid unnecessary alarms, eg.
Sometime in the Operation mode, door open by operator and it will be immediately
trigger an alarms due to differential pressure out of ranges. It is very difficult if we have
to acknowledge alarms and answer in the event of OOS/ CAPA raise by QA.
Statistical Process Control/ Conditioning Alarms should be implement and access
through Risk Management, Validated and Documented as evidence.
Review of Electronic Records and Electronic Signatures
BMS system continuously records data in real time monitoring with certain define
period of data collection. When BMS system consider and define as “critical” in the GMP
environment, assessment of direct impact to the system should be made. Relevant
parties should be manage, control on the reviewing of the electronic records, applies
signatures and by proper procedure.
Electronic records and signatures should be define clearly during generate the User
Requirement Specification (URS) and it is verify during design review and testing/
validation.
References
GAMP 5: Risk Based Approach to Compliant GxP
Computerized System.
Title 21 Code of Federal Regulation, 21 CFR Part 11:
Electronic Records, Electronic Signatures.
ISPE Pharmaceutical Engineering Guide, Commissioning
and Qualification.
