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Ventilation Air Conditioning (HVAC), Environmental monitoring, Fire Protection system, Alarms &
Surveillance System, Lift Management System, Smart Building Technologies and Energy
Conservations.
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.
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 preset 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.
References
Title 21 Code of Federal Regulation, 21 CFR Part 11: Electronic Records, Electronic
Signatures.