Approach to Validation

for
Process Control Systems

Prepared by Epitome Technologies Pvt. Ltd.,

Ahmedabad. India.
 VALIDATION APPROACH AND SCOPE
FOR
PROCESS CONTROL SYSTEMS
Page 2 of 10

Table of Contents:

1.0 OBJECTIVE ................................................................................................................................ 3

2.0 EXECUTIVE SUMMARY ............................................................................................................ 3
3.0 QUALIFICATION APPROACH .................................................................................................. 4
4.0 PROCESS CONTROL SYSTEMS – TECHNOLOGY LAYERS ................................................ 5
5.0 VALIDATION PROJECTS STEPS ............................................................................................. 7
5.1 DOCUMENT USER REQUIREMENTS SPECIFICATIONS .................................................................... 7
5.2 DEVELOP VALIDATION MASTER PLAN ......................................................................................... 7
5.3 DEVELOP VALIDATION PLANS ..................................................................................................... 7
5.4 STANDARD OPERATING PROCEDURES ........................................................................................ 7
5.5 PROCESS MAPPING AND QUALITY SYSTEM IMPACT ..................................................................... 7
5.6 RISK ASSESSMENT .................................................................................................................... 7
5.7 INSTALLATION QUALIFICATION (IQ) ............................................................................................. 7
5.8 NETWORK QUALIFICATION.......................................................................................................... 8
5.9 OPERATIONAL QUALIFICATION (OQ)........................................................................................... 8
5.10 PERFORMANCE QUALIFICATION (PQ) ......................................................................................... 8
5.11 VALIDATION REPORT .................................................................................................................. 8
5.12 DOCUMENTATION ...................................................................................................................... 8
6.0 ON GOING VALIDATION AND MAINTENANCE QUALIFICATION......................................... 9
7.0 SUMMARY.................................................................................................................................. 9
8.0 REFERENCES.......................................................................................................................... 10

Epitome Technologies Pvt. Ltd.

802, MAHALAY, Opp. Hotel President, Off C G Road, Navrangpura, Ahmedabad 380 009 Gujarat. India
Ph: +91 79 2656 8150 ; Fax: +91 79 2656 8096
E-mail vcmehta@epitome.co.in ; URL : http://www.epitometech.com
 VALIDATION APPROACH AND SCOPE
FOR
PROCESS CONTROL SYSTEMS
Page 3 of 10

1.0 Objective

The objective of this document is to highlight the qualification approach and major project
steps to ensure compliance for process control systems. The systems which are classified
as process control systems are

• Programmable Logic Controllers

• Supervisory Control And Data Acquisition Systems
• Distributed Control Systems
• Building Management Systems

2.0 Executive Summary

The purpose of carrying out validation of process control systems is not only to verify the
system configuration (hardware / software / loop and logic) as given by the system supplier;
but also to ensure that the respective process requirement specifications are incorporated in
the system.

During the process control systems validation it is imperative to carry out the Process
Mapping (Control Specifications verified against User Requirements). The configuration
gaps identified as a part of process mapping are to be evaluated for the risk involved (of not
having the respective controls). The High and Medium (in that order) gaps are addressed
either technically (by way of modifying the configuration) or with procedural controls.

Besides addressing the configuration gaps, it is also important to review and prioritize the
alarms and events defined in the systems. The alarm and event handling strategy will
identify the following

• Priority of each alarm and subsequent handling of the same

• Records of all High and Medium priority alarms and trend analysis
• Initiation of CAPA for identified group of Alarms ( mainly high priority)

Having completed the Process Mapping and Alarm Handling strategy, the validation will be
carried following the GAMP V model.

Epitome Technologies Pvt. Ltd.

802, MAHALAY, Opp. Hotel President, Off C G Road, Navrangpura, Ahmedabad 380 009 Gujarat. India
Ph: +91 79 2656 8150 ; Fax: +91 79 2656 8096
E-mail vcmehta@epitome.co.in ; URL : http://www.epitometech.com
 VALIDATION APPROACH AND SCOPE
FOR
PROCESS CONTROL SYSTEMS
Page 4 of 10

3.0 Qualification Approach

The following diagram covers the qualification approach for new as well as existing systems.

Master Plan, Policies, Procedures

Existing Systems

Inventory Assess for QS Assess for Perform Gap Develop/Implement

Systems Impact Product Risk Analysis Remediation Plan

Automated
Remediation
System
Plan
Inventory

New Systems

Define Design & Develop & Maintain Change

Validate
Requirements Configure Test Control

Part 11 compliance and validation are designed into process

For the new systems being implemented the approach would be as shown in the diagram
which will be following the V model of GAMP.

However, for the existing systems the approach would to perform the Quality System Impact
Analysis (identifying gaps in systems from functional / operational / compliance point of view
including risk assessment); address / close the gaps and then carry out the validation. Each
of these steps is elaborated in the respective Para.

Epitome Technologies Pvt. Ltd.

802, MAHALAY, Opp. Hotel President, Off C G Road, Navrangpura, Ahmedabad 380 009 Gujarat. India
Ph: +91 79 2656 8150 ; Fax: +91 79 2656 8096
E-mail vcmehta@epitome.co.in ; URL : http://www.epitometech.com
 VALIDATION APPROACH AND SCOPE
FOR
PROCESS CONTROL SYSTEMS
Page 5 of 10

4.0 Process Control Systems – Technology Layers

Plant And Information Management – SAP/MES

Alarms And Events Management –

Risk Management And CAPA

Operator Interface – Recepie Management

Controllers – Loop And Logic

Connectivity – Data Highway

Input / Output – Sensor Interface

Epitome Technologies Pvt. Ltd.

802, MAHALAY, Opp. Hotel President, Off C G Road, Navrangpura, Ahmedabad 380 009 Gujarat. India
Ph: +91 79 2656 8150 ; Fax: +91 79 2656 8096
E-mail vcmehta@epitome.co.in ; URL : http://www.epitometech.com
 VALIDATION APPROACH AND SCOPE
FOR
PROCESS CONTROL SYSTEMS
Page 6 of 10

5.0 Process Control Systems – Testing Strategy

Qualification Compliance approach

Element
Process Mapping To evaluate the control systems against the functional requirements of
the respective process. The systems’ gaps on respective process to be
addressed after due risk assessment
I/O Interface To assess the adequacy of the i/o capacity and the engineering like
configuration check for channel, range etc
Process Control To assess the adequacy and functionality of the loop and logic controls (
e.g. ladders in plc ) and verify processor capacity
Alarm And Event To assess the adequacy and priority of alarms and events defined in the
Handling system. Also to implement alarm handling procedures and controls
during system operations. To specifically prioritize the alarms and
events which will trigger CAPA.
Graphics To review the graphical user interface and PFK for interlocks/set
parameters and recipe operations.
Security To evaluate and challenge the systems for access control and password
policies.
Recipe Handling To review systems’ capabilities to handle various recipes and ensure
suitable user rights to down load / modify recipes.
Batch Scheduling To review systems’ configuration to start / stop various batches and the
access control / user rights there of.
Data Capture To map the data / records flow ( SCADA / Printer etc) and identify the
data as paper or electronic form
Alarm History To implement strategies for on line / historical evaluations and trending
of alarms and events. Also to define initiation of CAPA based on alarm
criticality.
Trending To evaluate trend definitions (SCADA / BMS / DCS) and data capturing
during the batch cycles.
Reporting To assess / evaluate reports defined in the system. Recommend
additional reports configuration if needed.
Data Backup And To review / define the procedures (SOPs) for data backup / recoveries
Recovery and other data management aspects.

Epitome Technologies Pvt. Ltd.

802, MAHALAY, Opp. Hotel President, Off C G Road, Navrangpura, Ahmedabad 380 009 Gujarat. India
Ph: +91 79 2656 8150 ; Fax: +91 79 2656 8096
E-mail vcmehta@epitome.co.in ; URL : http://www.epitometech.com
 VALIDATION APPROACH AND SCOPE
FOR
PROCESS CONTROL SYSTEMS
Page 7 of 10

6.0 Validation Projects Steps

Validation shall follow the steps as listed below:

6.1 Document User Requirements Specifications

A user requirements document will be developed as part of this validation effort. This
version-controlled document will formally specify client’s intended uses for the various
process control systems.

6.2 Develop Validation Master Plan

A Validation Master Plan will be developed to describe the objectives, scope, approach and
responsibilities for the process control systems validation. The validation master plan shall
be approved before any of the protocols are approved.

6.3 Develop Validation Plans

While the validation master plan shall define the general approach to validation, During each
validation projects (for newly added systems or new facility undergoing International audit); a
validation plan will be prepared which will be the project Specific plan for the activities to be
undertaken.

6.4 Standard Operating Procedures

Preparation / review of all the sops pertaining to operation and maintenance of process
control systems. These sops will cover both it sops and operational sops.

6.5 Process Mapping and Quality System Impact

To evaluate the control systems against the functional requirements of the respective
process. The systems’ gaps on respective process to be addressed after due risk
assessment.

6.6 Risk Assessment

Identify the various risk related to GMP to operate the process control system. Evaluate the
system design and if the risk cause not considered in the design then identify the suitable
mitigation and change the system accordingly. All risk identified during assessment process
should be challenged during the operation qualification.

Emphasis will be given to alarm and event conditions defined in the system and the

6.7 Installation Qualification (IQ)

Prepare installation qualification protocols for each sub system and carry out challenge
testing for recommended installation practices by the manufacturer / developer.

Prepare a discrepancy / deviation report.

Epitome Technologies Pvt. Ltd.
802, MAHALAY, Opp. Hotel President, Off C G Road, Navrangpura, Ahmedabad 380 009 Gujarat. India
Ph: +91 79 2656 8150 ; Fax: +91 79 2656 8096
E-mail vcmehta@epitome.co.in ; URL : http://www.epitometech.com
 VALIDATION APPROACH AND SCOPE
FOR
PROCESS CONTROL SYSTEMS
Page 8 of 10

6.8 Network Qualification (NQ)

Network qualification is associated with the network infrastructure of the process control
systems (DCS / BMS / SCADA) and is carried out as part of installation qualification.
Functions are verified to establish that the hardware and system software is installed in
accordance with design and vendor/manufacturer recommended practices.

6.9 Operational Qualification (OQ)

Prepare operational qualification protocols for each sub systems and carry out challenge
testing for systems functional and operational programs.

Prepare a discrepancy / deviation report.

6.10 Performance Qualification (PQ)

For the systems involving complex control loops performance qualification to be carried out
for the systems’ response and stability to process condition variations and load changes.

6.11 Validation Report

The test result summary and qualification status at the end of protocol execution to be
recorded in the validation report.

6.12 Documentation

On completion of process control system qualification, following documents will be available

as an evidence of validation activity:

• URS / FS
• Validation Master Plan.
• Validation Plan ( or project plan)
• Process mapping and quality system impact
• Risk Assessment Report.
• Installation Qualification Protocol and Report.
• Network Qualification Protocol and Report.
• Operation Qualification Protocol Report.
• Performance Qualification Protocol and Report.
• Deviation Reports.
• Qualification Summary Report.

Epitome Technologies Pvt. Ltd.

802, MAHALAY, Opp. Hotel President, Off C G Road, Navrangpura, Ahmedabad 380 009 Gujarat. India
Ph: +91 79 2656 8150 ; Fax: +91 79 2656 8096
E-mail vcmehta@epitome.co.in ; URL : http://www.epitometech.com
 VALIDATION APPROACH AND SCOPE
FOR
PROCESS CONTROL SYSTEMS
Page 9 of 10

7.0 On Going Validation and Maintenance Qualification

The completion of the qualification activities will initiate the on going validation and
maintenance qualification.

The activities generally covered are

• Hardware / Software Change Control

• Software Version Control And Patch Management
• Application Up-Grades
• Revalidation

8.0 Summary

Validation of process control systems is carried out on the basis of prevailing GAMP
guidelines which emphasizes risk based validation with life cycle approach. The activities
covered will be right from system user requirement specifications to maintenance
qualification and revalidation till the system is discontinued from the operations.

Epitome Technologies Pvt. Ltd.

802, MAHALAY, Opp. Hotel President, Off C G Road, Navrangpura, Ahmedabad 380 009 Gujarat. India
Ph: +91 79 2656 8150 ; Fax: +91 79 2656 8096
E-mail vcmehta@epitome.co.in ; URL : http://www.epitometech.com
 VALIDATION APPROACH AND SCOPE
FOR
PROCESS CONTROL SYSTEMS
Page 10 of 10

9.0 References

The publication listed below form part of this project being the reference documents. Each
publication shall be the latest revision and addendum in effect on the date of this proposal
shall be approved for execution unless noted otherwise.

Annexure 11 EU GMP regulation for Computerised system, EUDRALEX Volume 4

PIC/s guide Good practices for process systems in regulated “GxP” environments
GAMP 5 Good Automated Manufacturing Practices, Version 5, guideline document for
automated systems from international society of pharmaceutical engineering
GAMP guide Good practice guide – Testing of GxP systems
21 CFR 210 Code of federal regulations; current good manufacturing practicing
manufacturing, processing, packing, or holding of drugs
21 CFR 211 code of federal regulations; current good manufacturing practice for finished
pharmaceuticals
21 CFR 11 rule for electronic records and signatures
7132a.07 FDA’s compliance policy guide; process drug processing: input/output
checking
7132a.08 FDA’s compliance policy guide; process drug processing: identification of
persons on batch production and control records
7132a.11 FDA’s compliance policy guide; process drug processing: CGMP applicability
to hardware and software
7132a.12 FDA’s compliance policy guide; process drug processing: vendor
responsibility

Epitome Technologies Pvt. Ltd.

802, MAHALAY, Opp. Hotel President, Off C G Road, Navrangpura, Ahmedabad 380 009 Gujarat. India
Ph: +91 79 2656 8150 ; Fax: +91 79 2656 8096
E-mail vcmehta@epitome.co.in ; URL : http://www.epitometech.com