אביב צברי – עמוד 4

ולידציה – FRS – Regulatory & HMI Requirements

Posted on אוגוסט 6, 2015 by אביב צברי

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

Posted on אוגוסט 3, 2015 by אביב צברי

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

ולידציה – URS – Regulatory & HMI Requirements

Posted on יולי 28, 2015 by אביב צברי

ולידציה – URS – 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

Computerized system compliance 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

System capability of restricting logical access to the system according to specified authorization levels.

Access to the system allowed only by user ID and a specific password

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

Storage of historical events, current alarms and historical alarms data records on the computerized system database

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

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) protoco

HMI Requirements

These requirements cover the provisions demanded 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

: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 – URS Contents

Posted on יולי 26, 2015 by אביב צברי

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

Posted on יולי 22, 2015 by אביב צברי

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

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

אוטומציה ובקרה – PID Control

Posted on יולי 15, 2015 by אביב צברי

אוטומציה ובקרה – PID Control

Between the measuring device and the final control element comes the controller. Its function is to receive themeasured output signal Ym (t) and after comparing it with the set point Y_SP to produce the actuating signal c (t) in such a way as to return the out put to the desired value Y_SP. Therefore the input to the controller is the error ε(t) = Y_SP –Ym (t), while its out put is c (t). The various types of continous feedback controllers differ in the way they relate ε (t) and c (t).

The best feed back controller is the proportional – integral- derivative controller.

In the industrial practice it is commonly known as the proportional-plus-reset-plus-rate controller.

The actuating signal of this controller is given by the following mathematical equation.

c (t) = Kc ε (t) + Kc/Ʈ₁ ∫₀ ^t ε (t) dt + Kc Ʈ_D dε/dt + Cs

Kc = proportional gain of the controller

Cs = controllers bias signal (i.e. its actuating signal when ε =0)

Ʈ₁= integral time constant OR reset time in minutes

T_D= derivative time constant in minutes

Proportional = Kc ε (t)

Here the actuating out put c (t) is proportional to the error ε (t) = Y_SP –Ym (t),

It is clear that larger the gain Kc, the higher the sensitivity of controllers actuating signal to deviations (ε).

ie: Y _SP=100, Ym(t) =96, hence error ε = 4.

If Kc=1, then controllers actuating signal, c = 4% to close/open, for TCV.

If Kc=3, then controllers actuating signal, c= 12% to close/open, for TCV

Integral = Kc/Ʈ₁ ∫₀ ^t ε (t) dt

The reset time, Ʈ₁ is the time needed by the controller to repeat the initial proportional action change in its out put. Reset time, Ʈ₁is an adjustable parameter and some manufacturers do not calibrate their controllers in terms of Ʈ_1, but in terms of its reciprocals, 1/ Ʈ₁(repeats per minute), which is known as the reset rate.

ie:

Reset rate=0.1, it means the reset time is = 1/0.1= 10 scans, Hence every 10 scans the controller will add the proportional action change (Kc ε (t)).

In most of the PID's time scans is configurable and called "update loop time" if it equals to 1 then every 10 seconds the controller will add the proportional action

Remark:

The integral term of a controller causes its output to continue changing as long as there is a non-zero error. Often the errors cannot be eliminated quickly, and given enough time they produce larger and larger values for the integral term, which in turn keeps increasing the control action until it is saturated ( ie: the valve is completely open or closed) & called as integral wind up.

Derivative = Kc Ʈ_D dε/dt

Ʈ_{D is} the derivative time constant in minutes, with the presence of the derivative term, (dε/dt), the PID controller anticipates what error will be in the immediate future and applies a control action which is proportional to the current rate of change in the error. Due to this property, the derivative control action is referred to as anticipatory control.

Because of the forecasting action of the derivative parameter, the control valve will never "rest" it will always open and close to maintain the Setpoint therefore – this parameter must be used only for fast PID's such as compressed air control, Steam control, ETC

,This guide was written by llan shaya, control and automation specialist

סמארט לוג’יק מתכננת ומבצעת ביצוע פרויקטים הנדסיים בתחום הבקרה האוטומציה, בקרה מפעלית ובקרות תהליך, בקרות מבנה

מחבר: אביב צברי

ולידציה – FRS – Regulatory & HMI Requirements

ולידציה – FRS – Regulatory & HMI Requirements

Regulatory Requirements

HMI Requirements

ולידציה – FRS Contents

ולידציה -FRS Contents

Installation Requirements

Operation Requirements

ולידציה – URS – Regulatory & HMI Requirements

ולידציה – URS – Regulatory & HMI Requirements

Regulatory Requirements

HMI Requirements

ולידציה – URS Contents

ולידציה – URS Contents

Installation Requirements

Operation Requirements

ולידציה – URS and FRS Preparation Overview

אוטומציה ובקרה – PID Control

אוטומציה ובקרה – PID Control

מערכת בקרה מפעלית – רפא ירושלים

כתיבת פרוטוקולי ולידציה – וולטק קרדיו

פרמצבטית לפי דרישות HVAC – טבע מדיקל

מערכת אנרגיה חדשה – טבע מדיקל

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