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תגית: Validation

Validation is a collection of guiding rules according to which the quality of the production processes is tested. Validation relies on predetermined standards and Smart Logic, which specializes in control and automation, submits validation files in a fixed and defined format.

ולידציה – URS – Regulatory & HMI Requirements

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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 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 – Installation Qualification (IQ) Protocol – 2

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Installation Qualification (IQ) Protocol

Preparation Overview – part 2

 Installation Qualification (IQ) Protocol –  Test Procedures

This chapter contains all the test procedures or verifications 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

The next sections provide overviews of the main test procedures and verifications, and their purposes. This IQ procedure is generic, and relevance of the test procedures and verifications provided below depends on the composition of the system under validation.

Note:

As mentioned in the previous chapter on IQ Protocol Contents, the final contents of the IQ protocol are tailored according to the type and size of the system under validation. Since this document is generic, it covers test procedures that may not be necessary in small or simple systems.

Drawings Verification

This procedure is intended to obtain signed, updated copy of the user's Piping and Instrumentation Drawing (P&ID), and verify that the drawing is accurate.

 Site Preparations

This procedure is intended to verify that the system under validation is installed and operated under environmental conditions, in particular temperature conditions, which comply with the manufacturer’s requirements.

                          Hardware Installation Test Procedures

  Voltage Supply

This procedure is intended to verify that the voltage supplied to the system components complies with the design requirements.

 IO List

This procedure is intended to verify that the system components are identified and installed in compliance with the IO List, the P&ID, and the system hardware requirements.

                        Software Installation Test Procedures

This section describes the test procedures for the installation of purchased software (SW) and application SW. These test procedures are relevant when the supplier installs these SW systems.

Supplier Installed Software

This procedure is intended to verify that purchased SW installed in the supervisory computer and control system (where relevant) by the supplier complies with the SW design requirements.

 Other Purchased Software

This procedure is intended to verify that other purchased SW, such as a version of Windows, is correctly installed on the system.

  Application Software

This procedure is intended to verify that the custom application SW is installed according to the design requirements.

 Closed System Verification (Where Relevant)

This procedure is intended to verify that the system is closed, i.e., it cannot communicate with Internet networks.

Glossary

CFR Code of Federal Regulations
FDA Food and Drug Administration
FRS Functional Requirements Specification
HW Hardware
IQ Installation Qualification
OQ Operational Qualification
QA Quality Assurance
SSO Schedule of System Operation
SW Software
URS User Requirements Specification

ולידציה – Installation Qualification (IQ) Protocol

Posted on by אביב צברי

ולידציה – Installation Qualification (IQ) Protocol

Preparation Overview – part 1

The Installation Qualification (IQ) protocol is part of the validation documentation that covers the verification of the proper installation and operation of the system under validation in the user's facility. This IQ 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.

The IQ protocol is designed to verify that the system under validation is properly installed and can be properly operated according to the supplier's requirements and the user's specifications. It must be reviewed and approved prior to the IQ performance.

                            Installation Qualification (IQ) Protocol Contents

The IQ 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 IQ protocol includes the following chapters and sections

 Document Approvals – contains a table that lists the supplier's and user's personnel required to approve the protocol

Participants – contains a table with the supplier's and user's personnel that participate in the validation process and approve their participation

Responsibilities – lists the roles of supplier's and user's personnel responsible for writing and approving the protocol

Glossary – lists the acronyms used in the protocol

IQ Validation Approach – defines the scope of the IQ process, and the requirements for its successful completion

IQ 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

IQ Approvals – contains a table with the user's personnel responsible for reviewing and approving the test results, summary reports and conclusions

Appendices – include validation deviation forms and the documentation list with all the documents and drawings relevant to the IQ process

This is the first part of  the preparation overview in Installation Qualification (IQ) protocol, the second part is  IQ Test Procedures which will be discus elaborately in our next article.

ולידציה – Design Specification – DS

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ולידציה – Design Specification – DS

The Design Specification -DS is part of the validation documentation that provides information necessary to complete the design of the project. This document covers only the DCS side and integration with ELT-GHS-150-T3 Gas Heater skid

DS Content

The DS is usually 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 this DS are

Hardware Specification

Wiring and Electrical Cabinet Drawing

Communication and Network Design

Other Documentation

ProfiBus Monitoring Values List

Running Logic

Alarms List

Alarm Response

Disaster Recovery

Programming Design

Appendixes

Hardware Specification

.This section defines the required I/O allocation, according to the wiring diagram document No. P09204-020 Rev2, and 35800SIS0-N0

8 digital inputs

1 digital outputs

ProfiBus connection

Wiring and Electrical Cabinet Drawing

:This section lists the following design information

New Electrical drawing is not needed

:All I/O should be named in a standard fashion, i.e., XXXX-YYY-ZZZ, where

XXXX – 4 prefix letters which indicates the containing system; in this case, the system is PRMS

.YYY – indicates the instrument type according to Siemens naming standard – document no

ZZZ – indicates the serial continuing number

.Siemens Engineering file update is needed in Chapters18C 18D 18E. Other chapters should be examine and discussed in the FRS

.BOP PLC must be stopped during the wiring and ProfiBus module installation. Dalkia should be supply with time table

Communication and Network Design

:This section lists the following design information

.The communication used in this project is Profibus

.The Profibus communication protocol and wiring design will be provided by Siemens

.Siemens Engineering file update is needed. All communication and network chapters should be updated

Communication and Network Design

Siemens Engineering file "stand alone skids and instruments" chapter should be update; all Heater manuals and instructions should be attached to this chapter.

ProfiBus Monitoring Values List

tSP Target Setpoint – Setpoint differential CT15/14 – CT15/13

All  Operator.MAIN items – To be later configured

All Operator. SYSTEM.StatusWords.Output) – To be later configured

Man Manual/Auto Mode 76 AUTO (0) – +VFD manual percents

Running Logic

start conditions

Heater valve V101 is open. – GS101 HEATER INDICATION.

Heater valve position V102 is open.

Heater bypass valve V103 is closed.

DCS 10EKA01CF001>1500m3h (indicating that at list one of the gas turbines is on).

DCS 25Barg<10EKA001CP001<45Barg (Gas pressure operation range).

All Heater trips are acknowledged and cleared.

Operator pressed "Start" from DCS.

Alarms List

All alarms from profibus

Alarm Response

Holding/Restart Logic

No alarm response from the DCS.

Disaster Recovery

Perform stop operations as in paragraph

  1. Power shut down
  2. Compressed air supply shut down

 Programming Design

AS (Automation system – PLC) that will be programmed in this integration will be BOP.

The synoptic screen will be programmed and be added to the PRMS screen, as described in Appendix 1 – Synoptic Screen.

All instruments, EG valves and transmitters, will be created according to Siemens standards.

All instruments will be set to READ ONLY, except the START and STOP buttons.

Appendixes

The DS appendixes present examples of design drawings.

Appendix 1 – Synoptic Programming Design.

Appendix 2 – Chapter 18E BOP Example of Electrical Drawing (to be updated)

Appendix 3 – Example of Network Drawing (to be updated)