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ולידציה – SSO for Turbine Air Inlet Cooling

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   Schedule of System Operation – SSO

Turbine Air Inlet Cooling

This article is an elaborated example of a schedule of system operaton – sso we did for one of our clients. Of course the actual documents contain all the operational and alarm parameters  

                Scope

This Schedule of System Operation (SSO) covers the required technical data and operation logic regarding the components of Turbine Air Inlet Cooling system, according to the Smartlogic's requirements and the client specifications

              System General Description

 :Turbine Air Inlet Cooling system contains two cold liquid circuits

Primary – 4 chillers and their respective primary pumps

Secondary – 2 pumps for each turbine inlet air cooling coil, 2 pumps for Cogen1, 2 pumps for Cogen2, and 2 pumps for the electric generator cooling (one operating and the other in standby

                Applicable Documents

User Requirements Specification (URS) for Monitoring and Alarm System

Parameters List

            Operational Parameters List

                          Alarm Parameters List

                              Operation Logic

            :Start Conditions of Chiller

COND_SYS_RDY Signal is on
Relevant pumps are waiting for our commands, including their corresponding valves

OIL_PUMP_OK Signal is on

READY Signal from MCC (C-025/RD) is on

READY Signal from Chiller (JM-025/RD) is on

ZS (Freeze protector) Signal is off, not indicating alarm

           : Running Logic for Chiller

Start corresponding Reg_valve (condenser regulate valve) on 100% and wait until valve feedback indicating >= 95%

Delay REG_VALVE_DLY_SP – 10 second

:If number of operating chillers <= 2

Send signal to  Start_cond_pump_1 – Start one Condense Pump

:If number of operating chillers > 2

Send signal to  Start_cond_pump2 – Start Two Condense Pumps

Verify from via communication that relevant cond_pump has

Delay 20 seconds

Perform PID on PDIT using Reg_valve according to relevant PDT-081-4_SP DeltaP SP
(in manual and/or auto mode)

Start CHW_Pump, chilled water pump

Delay 30 second

Verify relevant FS (flow) Signal is on for 20 seconds

Start Chiller

           : Stop operation for each Chiller

Delay 2 minutes , safety in case user changed the operation order of chillers from HMI

Stop Chiller

Wait for signal off from motor MCC feedback

Delay 60 Sec

If current chiller is 3rd , Send signal to stop Cond_pump_2

If current chiller is 1st , Send signal to stop Cond_pump_1

Close Reg_valve, condenser regulate valve

Delay 30 Sec

Stop CHW_Pump, chilled water pump
Interlock: in any case, CHW_Pump will continue operating as long as the corresponding chiller is operating

            Consumers Pump activation

User can always choose primary/secondary pump

If demand cooling for cogen1/2 via .DI 20 for cogen 1, DI 21 for cogen 2

For first activation: Check TT-087 (supply water) is below SP +1

:Perform PID control with relevant Cogen-TT
For Cogen-1 TE-315-022, for Cogen-2 TE-316-093
according to TT_315_022_SP / TT_316_093_SP using cogen-1/2 primary pump

If PID control loop reaches >= START_HZ_SP activate secondary pump and Continue PID control loop with both primary and secondary pumps

If both primary and secondary pumps at work and PID control loop reaches <= STOP_HZ_SP deactivate secondary pump and Continue PID control loop with primary pump only

If outlet air from cogen 1 or 2 below setpoint -2°C and the pump speed in minimum for 3 minute, stop the cogen pump

When the outlet air is above set point +1°C for 1 minute start the pump

*Generator equipment is not connected to the our PLC

           :Consumers Pumps activation for generator

If number of operating chillers <= 2 then activate first pump

If number of operating chillers > 2 then activate second pump

Stop pumps using reverse order

            :Temperature control for generator valves

Perform PID control with TT-090 according to SP using TV-088, If 316-J-21A operates

Perform PID control with TT-090 according to SP using TV-089, If 316-J-21B operate

           :Start Conditions of Chiller sequence

Demand Cooling at least from one of Cogen-1 / Cogen-2 / Generator. slot 4 DI-19-20-21

            :Chiller sequence run-up

Start first chiller according ‎6

The chilled water pump in the first chiller will start all the time even if we are not receive "chiller ready to start", we do need to receive "MCC ready" and do not receive "chiller shut down" . this function are necessary when the chiller stop in" low water temperature"

Delay Run-up Start_Chiller_DelaySP delay – 10 minutes

According to demand, start next chiller

:Perform sequence control using the maximum calculated value from
:{Flow measurement} calculation and {Temp measurement} calculation

:By flow measurement

Chiller #2 operates when total flow is > CH2_FLOW_SP + CH_FLOW_OFFSET_ SP

Chiller #3 operates when total flow is > CH3_FLOW_SP + CH_FLOW_OFFSET_ SP

Chiller #4 operates when total flow is > CH4_FLOW_SP + CH_FLOW_OFFSET_ SP

Chiller #2 stops when total flow is <= CH2_FLOW_SP – CH_FLOW_OFFSET_ SP

Chiller #3 stops when total flow is <= CH3_FLOW_SP – CH_FLOW_OFFSET_ SP

Chiller #4 stops when total flow is <= CH4_FLOW_SP – CH_FLOW_OFFSET_ SP

Total flow = FM1 + FM2 + GenFM

Here are some examples of the PLCs used by Smartlogic: 6XV1830-0EH10, 6ES7131-4BF00*0AA0, 6ES7193-4CA40-0AA0, 6ES7134-4GD00-0AB0, 6ES7193-4CA40-0AA0, 6ES7138-4CA01-0AA0, 6ES7193-4CC20-0AA0, 6ES7590-1AB60-0AA0, 6ES7511-1AK00-0AB0, 6ES7954-8LP01-0AA0, 6ES7155-6AU00-0BN0, 1746-NO4V, 1769-L16ER-BB1B

 

ולדיציה – Validation case study – part 1

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ולדיציה -1 Validation Requirements – case study- part

 This article was written by Iian Shaya, validation,automation and control expert

Validation Requirements is a document which may be part of the validation documentation that describes the validation strategy for a system or subsystem. This document is generic; the system or subsystem may include a PC with Human/Machine Interface (HMI), a Programmable Logic Controller (PLC), virtual hardware (HW), software (SW), and other components designed to maintain the user's facility in proper conditions specified by the user.

Validation Requirements Document Contents

This document is structured in a relatively standard fashion, with predetermined chapters and sections, where the final contents are tailored according to the type and size of the system under validation.

The main chapters and sections of a Validation Requirements document are:

Responsibility

Validation Requirements

Documentation for Initial Tender

Documentation for Design Review

Documentation Prior to Factory Acceptance Test (FAT) or Pre-Delivery Inspection – PDI

Commissioning

Documentation For Installation and Operational Qualification (IQ and OQ) – to be checked at PDI/FAT

Design Qualification (DQ) Protocols (Including PC/PLC) Architecture

Installation Qualification (IQ) Protocols (Including PC/PLC

Operational Qualification (OQ) Protocols (Including PC/PLC

Performance Qualification (PQ) Protocols

Computerized System Validation

Responsibility

This section lists the responsibilities of contractor, the user, and the required contents of the documents composing the validation file

The contractor is responsible for creation and performing the DQ, Design Review, Commissioning, IQ and OQ validation protocols

The user is responsible for creation and performing the PQ validation protocols

Design Qualification (DQ) – The design of the system will be documented and checked in the Design Specification. This specification will include details of the system and must be traceable to the URS and BOD documents

Mechanical Completion Check Report (MCCR) of the system will be documented and checked only by the contractor. This document will check system readiness for the IQ

Commissioning Execution (CE) of the system will be documented and checked only by the contractor. This document will check system readiness for  OQ

Installation Qualification –IQ

IQ will establish documented evidence that the system is installed according to the manufacturers’ specifications and user requirements, and assure that the environment is appropriate for its intended purpose

Each IQ protocol will include an appendix of deviation report, which describes the deviations (if they existent) of the specific system, and the contractor will be responsible to correct them

Operational Qualification – OQ

OQ will establish documented evidence that the system is operated according to manufacturers’ specifications and user requirements, and assure that the environment is appropriate for its intended purpose

OQ will establish documented evidence that the system is operated according to manufacturers’ specifications

.Each OQ protocol will include an appendix of deviation report, which describes the deviations (if they existent) of the specific system, and the contractor will be responsible to correct them

Performance Qualification- PQ

PQ will establish documented evidence that the system performs according to manufacturers’ specifications and user requirements, and assure that the environment is appropriate for its intended purpose

The PQ protocols are user's responsibility

 This article was written by Iian Shaya, validation,automation and control expert

ולידציה – Function Design Specification – FDS

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ולידציה – Function Design Specification – FDS

 This article was written by Iian Shaya, validation,automation and control expert

The Function Design Specification (FDS) is part of the validation documentation that details the solution to be provided to meet the user's requirements. It should be approved by the user and should form the basis of the design for both hardware (HW) and software (SW) designs.

The FDS provides the basis of the design of the system and is used to verify and validate the system during the testing, ensuring all the required functions are present and that they operate correctly. It details all the functions, operator interactions control and sequencing associated with the system, thus allowing the user to confirm, before the system is developed that the proposed solution fully meets its requirements.

FDS Contents

The FDS is structured in a relatively standard fashion, with predetermined chapters and sections, where the final contents are tailored according to the type and size of the system under validation. The FDS presented here includes only to the technical contents. It does not include commercial and contractual requirements, which may also be generally included.

The main chapters and sections of an FDS protocol are:

Relationship to Other Documents – lists all documentation used in the production of the FDS. Includes suppliers' documents (such as URS) and drawings. Each document listed should include the document/drawing number and version number. This allows traceability as documents are updated throughout the project life cycle on any impact on the FDS.

System Overview

Process Overview – includes a description of the process being controlled; this may be taken from the URS, enhancing to detail the interaction with the control system.

Control System Overview – includes detailed control system description, with all the components and interaction between the systems; block and network diagrams can be used to show in detail the system architecture

Scope and Limits of Supply

Scope of Supply – includes a list of deliverables, panels, computers, software, etc

Limits of Supply – includes all items outside the scope of the supply required by the project; where interfacing to 3rd party systems, constraints and assumptions should be included

System Functions and Facilities

Operation Modes – includes all modes of operation for the system

Functional Operation – divides each of the sequences functions into logical areas (determined by the process), and provide complete description of each area

Operator Requirements – describes the interface between the operator and the detailed function

Human/Machine Interface- HMI – details all points of operation, local terminals, remote terminal, message displays, push button stations, etc.

Report Outputs – the format of all reports generated by the system should be detailed, and that the format and explanation of the report contents should be included

System Data – all data gathered, generated or calculated by the system should be detailed

System Interfaces – provide complete details of all inputs and outputs from the control system

System Attributes

Availability – defines expected "working" time of the system between failures

Maintainability – details issues related to maintainability of the plant, in particular for systems that require regular maintenance to ensure the reliable operation

Transport and off loading

Power and services required

Connections to existing/3rd party systems

Changes to existing plant or hardware (HW) equipment

Changes to existing software (SW) systems

Training – details the formal and informal training to be supplied under the contract

Design Factors – details special factors relating to the design of the system, standards and methodologies to be followed for both the HW and SW development

Development Factors

Project Control – includes or makes reference to project plans and timescales, along with details of quality requirements, standards, test and integration and configuration management

Resource Requirements – includes the basic project team provided by the supplier, the access required to the customer's premises, and input and timing required by the customer into the project

Test procedures – including details of all test documentation and responsibilities for testing both offline and online

Module and Integration Testing

Factory Acceptance Testing (FAT) – performed at the suppliers premises

Site Acceptance Testing (SAT) – performed on completion of commissioning to demonstrate pre-handover system operation

:Note

As the final contents of the FDS are tailored according to the type and size of the system under validation, and this document is generic, it covers test procedures that may not be necessary in small or simple systems. The following sections cover the FDS issues that require further details

 About the system functions and facilities in our next article FSD System Function & Facilities

 This article was written by Iian Shaya, validation,automation and control expert

אילן שעיה ilan Shaya

ולידציה – FRS – Regulatory & HMI Requirements

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ולידציה – FRS – Regulatory & HMI Requirements

 This article was written by Iian Shaya, validation,automation and control expert

Regulatory Requirements

These requirements cover all the FDA specifications regarding the system compliance with the 21 CFR Part 11 definitions, and also with usual validation documentation demands

Method to provide a computerized system that complies with 21 CFR Part 11 definitions, such as the system access control by the user's managing personnel, who shall be responsible for the content of the electronic records (ERs) contained in the system

Method to restrict logical access to the system according to specified authorization levels

Method to restrict logical access to the system only to specific user ID and password

Method to provide system capability to record the values, alarms, user changes and any other events, and provide readable forms and reports of ER data

Method to allow storage of historical events, current alarms and historical alarms data records on the computerized system database

Capability of data display to the user in "view only" mode, so the user cannot alter or delete data/records

Provision of user's capability to backup data daily, weekly and monthly, according to his procedures, to ensure protection of the records and to enable their accurate and ready retrieval throughout the records retention period

Provision by the supplier of a project plan and quality assurance (QA) processes during development and the testing stages as part of his QA systems

Provision by the supplier of the following documents

Functional Requirements Specification – FRS

Functional Design Specification- FDS

IO List

Schedule of System Operation – SSO

Installation Qualification (IQ) protocol

Operation Qualification (OQ) protocol

Performance Qualification (PQ) protocol

HMI Requirements

These requirements are intended to provide the URS demands from the HMI screens, regarding proper graphic design and functionality for controlling and monitoring the system, as specified in customer's contract with the supplier. The HMI screens provided usually are of the following types

Main Screen

Synoptic screens for displaying online values and status

Parameters screens for displaying temperature, humidity and pressure parameters values

Data logging and storage of historical trends, alarms and events

Tabular screens for displaying alarms

Graphical screens for displaying trends

 This article was written by Iian Shaya, validation,automation and control expert

ולידציה – FRS Contents

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ולידציה -FRS Contents

 This article was written by Iian Shaya, validation,automation and control expert

The FRS presents functional requirements for installing and operating a monitoring and control system, in response to and compliance with the user's requirements

For example, the FRS may propose to fulfill the URS requirements using a system that includes a PC with control capabilities using HMI screens, PLC, and varied environmental conditions sensors and control devices. The FRS may also propose a color-code display for ongoing environmental conditions, including indications of alarm conditions. An SMS or e-mail notification may be sent to specified personnel in case of specified alarm conditions.

The FRS requirements are organized accordingly with the same order and numbering of sections as the URS for clear correspondence. These requirements are divided into 4 categories- as the user's requirements

Installation Requirements

Operation Requirements

Regulation Requirements

HMI Requirements

Installation Requirements

These requirements cover all the issues regarding system installation to ensure its proper functionality and reliability. Examples of this type of requirements are

List and characteristics of specified hardware (HW) components capable of meeting the system functional requirements

Labeling and identification method for each HW component

List and characteristics of specified software (SW) programs installed on the system PC and the PLC, capable of performing the required operations

Definition of equipment to meet the storage capacity requirements

Definition of equipment and method for achieving the required connections to various types of sensors, communication units, temperature, humidity and pressure transmitters, illumination devices, etc

Definition of equipment and method for achieving the communication compatibility with equipment already installed at the user's facility without extra sensors

Operation Requirements

These requirements cover all the operations that the system must be capable of performing. Examples of this type of requirements are

Environmental conditions (such as pressure, temperature and humidity) to be monitored and controlled

Type of systems to be monitored and controlled, such as Heating, Ventilation and Air Conditioning (HVAC) system, types of sensors, etc

Definition of computerized system capabilities and starting conditions

Definition of system capabilities to recover from failures

List of internal tests to be performed regularly, and alarm indications to be issued in case of failure

Definition of current and historical alarms to be provided regarding all parameters in any case of deviation from the limits specified in the system

Definition of system real-time screens display capabilities

Provision of the following data and HMI displays

Synoptic screens for displaying online values and status

Data logging and storage of historical trends, events and alarms

Tabular screens for displaying events and alarms

Graphical screens for displaying trends

Display of the following information for each alarm

Status -new/acknowledged alarm

Time at which the alarm was activated

Parameter/Tag/Name of the module that activated the alarm

Alarm Description

Alarm Priority

Display of alarms to warn the user, collect alarm history, and enable the user to view current and historical alarms. The system alarms shall include

Component malfunction/failure

Irregularity in parameter reading – such as disconnection of communication lines

Parameters values exceeding the high/low parameter limits

Deviations of system operation from predefined parameters/operations

Method for providing capability to configure the graphs parameters according to

Date and time

Measured parameters

Predefined number of displayed parameters

Definition of trend graphs with maximum and minimum allowed limits of the monitored parameters

Definition of logging interval defined by the user and configured by the supplier

Method for providing capability of authorized user's personnel to define low and high limits and delay time for each

alarm parameter

On FRS regulatory & HMI Requirements you can find out in our next article

 This article was written by Iian Shaya, validation,automation and control expert

אילן שעיה מרצה Ilan Shaya

ולידציה – URS Contents

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ולידציה – URS Contents

 This article was written by Iian Shaya, validation,automation and control expert

A URS usually presents the user's requirements for installing and operating a system designed to monitor and control specified conditions at its facility

:The user's requirements may be divided into 4 categories

Installation Requirements

Operation Requirements

Regulation Requirements

HMI Requirements

Installation Requirements

These requirements are intended to cover all the issues regarding system installation to ensure its proper functionality and reliability. Examples of this type of requirements are:

List of required hardware (HW) components, such as system PC, Programmable Logic Controller* (PLC), and varied environmental conditions sensors and control devices

Labeling and identification requirements for each HW component

Requirements for the software (SW) programs installed on the system PC

Storage capacity

Required connections to various types of sensors, communication units, temperature, humidity and pressure transmitters, illumination devices, etc

Communication compatibility with equipment already installed at the user's facility without extra sensors

Operation Requirements

These requirements cover all the operations that the system must be capable of performing. Examples of this type of requirements are

Environmental conditions (such as pressure, temperature and humidity) to be monitored and controlled

Type of systems to be monitored and controlled, such as Heating, Ventilation and Air Conditioning (HVAC) system, types of sensors, etc

Computerized system capabilities and starting conditions

System capabilities to recover from failures

Internal tests to be performed regularly, and alarm indications to be issued in case of failure

Provision of current and historical alarms regarding all parameters in any case of deviation from the limits specified in the system

System real-time screens display capabilities

Provision of the following data and HMI displays

Synoptic screens for displaying online values and status

Data logging and storage of historical trends, events and alarms

Tabular screens for displaying events and alarms

Graphical screens for displaying trends

Display of the following information for each alarm

Status – new/acknowledged alarm

Time at which the alarm was activated

Parameter/Tag/Name of the module that activated the alarm

Alarm Description

Alarm Priority

Display of alarms to warn the user, collect alarm history, and enable the user to view current and historical alarms. The system alarms shall include

Component malfunction/failure

Irregularity in parameter reading – such as disconnection of communication lines

Parameters values exceeding the high/low parameter limits

Deviations of system operation from predefined parameters/operations

Capability of configuring the graphs parameters according to

Date and time

Measured parameters

Predefined number of displayed parameters

Trend graphs with maximum and minimum allowed limits of the monitored parameters

Logging interval defined by the user and configured by the supplier

Capability of authorized user's personnel to define low and high limits and delay time for each alarm parameter

  .On URS regulatory & HMI Requirements you can find out in our this link: URS – Regulatory & HMI Requirements

*Here are some examples of the PLCs used by smartlogic: 6XV1830-0EH10, 6ES7131-4BF00-0AA0,6ES7193-4CA40-0AA0,6ES7134-4GD00-0AB0,6ES7193-4CA40-0AA0, 6ES7138-4CA01-0AA0,6ES7193-4CC20-0AA0, 6ES7590-1AB60-0AA0, 6ES7511-1AK00-0AB0, 6ES7954-8LP01-0AA0,6ES7155-6AU00-0BN0

 This article was written by Iian Shaya, validation,automation and control expert

ולידציה – URS and FRS Preparation Overview

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ולידציה – URS and FRS Preparation Overview

 This article was written by Iian Shaya, validation,automation and control expert

User Requirements Specification (URS) and Functional Requirements Specification (FRS) are the first and starting points of a validation process and a validation documentation file

  – The validation process must comply with regulations issued by the United States Food and Drug Administration FDA

:The FDA regulations that are most relevant to the validation process are

Good Manufacturing Practice  – GMP.

Current Good Manufacturing Practice – cGMP

Good Automated Manufacturing Practice – GAMP

The validation process includes design, installation and operation of a monitoring and control system for a production facility, as well as planning and execution of test procedures, to verify that a monitoring and control system meets the FDA standards

Validation documentation is part of the validation process that includes written and/or electronic records regarding the installation and operation of the monitoring and control system, and the corresponding test procedures for this system

Electronic records are often required to fulfill regulations set by the FDA. These regulations regard the scope and application of Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11). Electronic Records may contain any combination of text, graphics, audio, pictures, or other information represented in electronic form, which are created, modified, maintained, archived, retrieved or distributed by a computer system

Electronic Signatures may contain computer data compilation of any symbol or series of symbols executed, adopted or authorized by an individual to be legally binding equivalent of the individual's handwritten signature

Electronic records and signatures are generally used in Closed Systems, in which the system access is controlled by personnel responsible for the contents of the system electronic records

The responsibility for writing and approving the URS and FRS is shared in practice by the user, who operates the production facility, and the supplier or vendor, who provides the monitoring and control system for ensuring the proper operation of the production facility. Usually, the URS is written by the user and the FRS by the supplier

:Note

The final contents of the URS and FRS are tailored according to the type and size of the system under validation. Since the URS and FRS regarded herein are generic, they include requirements that may not be necessary in small or simple systems

 This article was written by Iian Shaya, validation,automation and control expert

ולידציה – DQ – Design Review

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 ולידציה – DQ – Design Qualification / Design Review

DQ  – Design Qualification is for Design Review by verifying that the system has been designed as specified in the URS (User Requirements Specification), FDS (Functional Design Specification), and relevant equipment specifications satisfying all GMP requirements. The Process User Requirements in the URS have been identified by the Quality Risk Assessment. Since the Quality Risk Assessment is an iterative process, it may be performed again, whenever necessary, during the DQ and subsequent lifecycle qualifications.  For  hardware and software of the control system, verification data will be collected to prove that the system has been designed in accordance with the URS and FDS including the requirements of 21 CFR Part 11. As DQ is the final step to formally review and document the proper design of the system, the protocol must enable the reviewers to verify that all quality-critical attributes and essential technical attributes of the system have been incorporated in the design. When the DQ report is approved, the system is ready for fabrication and construction.

DQ PROTOCOLS
PROCESS EQUIPMENT AND SYSTEMS
Media Preparation and Hold Tanks
Buffer Preparation and Hold Tanks
Process Tanks
Reactors – Organic Synthesis
Bioreactors
Evaporator Systems
Distillation Tower Systems

CLEAN UTILITY SYSTEMS
USP Purified Water Storage and Distribution Systems
WFI Storage and Distribution Systems
Clean Steam Generation and Distribution Systems
Process Air Systems
Nitrogen Gas Systems

SUPPORT SYSTEMS
CIP Systems
Biowaste Kill Systems – Continuous
Biowaste Kill Systems – Batch
Autoclaves

HVAC SYSTEMS AND CLEANROOMS
HVAC Systems
Cleanrooms – Aseptic
Air Locks – Gowning

LABORATORY EQUIPMENT
Incubators
CO2 Incubators
Water Bath Incubators
Ultra-Low Temperature Freezers
Refrigerators

ולידציה – FRS for Compliance with 21 CFR Part 11

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Functional Requirements Specification -FRS Regarding Requirements for Compliance with 21 CFR Part 11

This FRS presents SmarLogic's functional requirements in response to the User Requirements Specification (URS) . These functional requirements should be met in order to ensure  Control and Monitoring System complies with 21 CFR Part 11.

This FRS must be considered for the system design, build, installation, operation and testing requirements, and for traceability purposes along the product life cycle up to the Operational Qualification (OQ) stage.

                              Responsibility

The Validation Engineer is responsible for writing this protocol. The Control, Automation & Validation Engineer is responsible for ensuring the preparation and approval of this protocol.

The Control Engineer, Division Process Engineer and QA Manager are responsible of approving this document before development and on-site implementations.

The following sections list the functional requirements determined by the relevant groups of the system upgrading. Each functional requirement number is followed by the corresponding user requirement paragraph number for design qualification purpose

                            Glossary

ER – Electronic Record

DB – Database

FRS – functional requirements Specification

HMI – Human/Machine Interface

HSP – High Set-Point

HW – Hardware

IQ –  Installation Qualification

LSP –  Low Set-Point

OQ – Operational Qualification

OS – Operating System

PLC ָָ*- Programmable Logic Controller

QA – Quality Assurance

SCR – Screen

SOP – Standard Operating Procedures

SP – Set-Point

SSO – Schedule of System Operation

SW – Software

TP – Test Point

URS – User Requirements Specification

Requirements for Meeting 21 CFR Part 11

                        Top-Level Requirements

This section covers the proposed solutions for meeting 21 CFR Part 11 presented in the URS for a new WinCC HMI System. This system must allow the :following five main functionalities

Ensure the system integrity

Control the access to the system by logical security

Audit events that create and modify electronic records

Apply electronic signatures to the system

Backup and archive data to ensure record integrity in case of failure

                      Detailed Requirements

This section describes SmartLogic's solutions that will meet the detailed requirements listed in the URS. These requirements are divided into 6 categories for the sake of clarity:

Electronic Records

Security

Audit Trail

Archive

Backup

* Here are some examples of the PLCs used by smartlogic: 6XV1830-0EH10, 6ES7131-4BF00-0AA0,6ES7193-4CA40-0AA0,6ES7134-4GD00-0AB0,6ES7193-4CA40-0AA0, 6ES7138-4CA01-0AA0,6ES7193-4CC20-0AA0, 6ES7590-1AB60-0AA0, 6ES7511-1AK00-0AB0, 6ES7954-8LP01-0AA0,6ES7155-6AU00-0BN0