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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 – Regulatory & HMI Requirements

Posted on 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 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) 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 and FRS Preparation Overview

Posted on 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

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 – 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

ולידציה – Operation Qualification – OQ- part 1

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ולידציה – Operation Qualification – OQ- part 1

Protocol Preparation Overview

The Operation Qualification (OQ) protocol is part of the validation documentation that covers the verification of the proper operation of the system under validation in the user's facility. This OQ protocol is generic, and the system may include a PC with Human/Machine Interface (HMI), a Programmable Logic Controller* (PLC), pressure, temperature and humidity transmitters, and other monitoring and control components designed to maintain the user's facility in proper environmental conditions (temperature, pressure and humidity)

This OQ protocol is intended to verify that the system under validation operates according to the acceptance criteria specified in the Schedule of System Operation (SSO), and also meets the vendor's requirements and the user's specifications. It must be reviewed and approved prior to the OQ performance

OQ Protocol Contents

The OQ protocol 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 chapters and sections of an OQ protocol are

Documents Verification – procedure intended to verify that all the documents required for performing the OQ procedure are approved and available

OQ Test Procedures – this is the main part of the protocol, and provides the description of the test procedures and the result tables for filling and approving the test results

: Note

As the final contents of the OQ protocol 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

Documents Verification

:This procedure is intended to verify that all the documents required for performing the OQ procedure are approved and available. These documents are

Functional Requirements Specification (FRS)

Installation Qualification (IQ) Protocol

Piping and Instrumentation Drawing – P&ID

Input/Output (I/O) List

Schedule of System Operation (SSO)

OQ Test Procedures

This chapter contains all the test procedures or verification required to verify the system under validation is properly installed and can be properly operated according to the supplier's requirements and user's specifications

:Each test procedure or verification must include the same contents

Purpose or Objective

Procedure or Method

Acceptance Criteria

Test Results

*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