COMPUTER SYSTEM/

PLC VALIDATION
Current Phase of the 21 CFR Part 11 Proposed Process
 WHAT IS CS/PLC VALIDATION
WHY VALIDATION IS NEEDED 1, 2
WHO CARES ABOUT CSV
WHO GOVERNANCE
RESPONSIBILITIES & SOPS
HOW DO I COMPLY
SYSTEM AND INVENTORY ASSESSMENT
SYSTEM SPECIFICATION VALIDATION PROTOCOLS
VALIDATION DOCUMENTATION
Content PRE-VALIDATION PROCESS
VALIDATION MASTER PLAN
GAMP 4 & 5 CATEGORIES
SPECIFICATION AND QUALIFICATION RELATIONSHIPS
THE VALIDATION PROCESS
VALIDATION PROCESS STEPS
INITIAL RISK ASSESSMENT- STEP 1, STEP 2, STEP3
TESTING DOCUMENTATION

FUNCTIONAL RISK ASSESMENT

LEVERAGING SUPPLIER INVOLVEMENT

RESOURCES AND REFERENCES
THANK YOU
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WHAT IS CS/ PLC VALIDATION
The purpose of the validation process is to provide a high degree of assurance that a
specific process (or in this case computer system) will consistently produce a product
(control information or data) which meets predetermined specifications and quality
attributes

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WHY VALIDATION IS NEEDED
FDA regulations mandate the need to perform Computer System Validation and these
regulations have the impact of law.
Failing an FDA audit can result in FDA inspectional observations (483s) and warning
letters.
Failure to take corrective action in a timely manner can result in shutting down manufacturing
facilities, consent decrees, and stiff financial penalties.
The ultimate result could be loss of jobs, indictment of responsible parties (usually the
officers of a company), and companies suffering economic instabilities resulting in
downsizing and possibly eventual bankruptcy.

Key Objectives

Patient safety
Product quality
Data integrity

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WHY VALIDATION IS NEEDED
Reduces risk and legal liability
Having the evidence that computer systems are correct for their purpose and operating
properly represents a good business practice
Software is constantly evolving to keep up with the increasingly complex needs of the
people that use it; therefore validation is an ongoing necessity
Validation is applied to many aspects of the healthcare and other regulated industries and
businesses.
Examples include:
Services
Equipment
Computer Systems
Processes
In each case, the objective of validation is to produce documented evidence, which provides
a high degree of assurance that all parts of the facility will consistently work correctly when
brought into use.
Computer systems validation includes validation of both new and existing computer
systems.

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WHO CARES ABOUT CSV?
Systems throughout the organization involved in the development, production, storage and
distribution of pharmaceutical products or medical devices have to be considered

Resources involved in any way with IT, computer or automated systems is affected:
Developers
Maintainers
Users
Regulatory Authorities
QA

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WHO GOVERNANCE
Policies and procedures
Roles and responsibilities
Training
Supplier relationships
System inventory
Planning for compliance & validation
Continuous improvement

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RESPONSIBILITES & SOPs
Each corporate [business] unit is responsible for establishing a policy on computer
systems validation requirements.

Site or departments are responsible for:

Computer system validation Standard Operating
Procedures (SOPs)
System inventory and assessment
System specific validation protocols
System specific validation documentation

SOPs must:
Comply with the Computer Systems
Validation Policy and any Business Unit
policies that may apply
Be approved by the appropriate
management for that site or department

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HOW DO I COMPLY

Quality Assurance Systems

Analytical Control

Validation & Calibration

Equipment Control

Process Control

Material Control

Supplier Management

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SYSTEM AND INVENTORY
ASSESSMENT
Site or departmental management is responsible for compiling and maintaining
details about their computer systems.
This information includes identifying the systems that are being used and for
what purposes those systems are being used.

The system inventory and assessment information is used to determine which

systems need to be validated.

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SYSTEM SPECIFIC VALIDATION
PROTOCOLS
Validation protocols are documents associated
with each system identified as requiring
validation.

The protocol describes the scope, procedure to be

followed, responsibilities and acceptance criteria
for the validation.

Validation protocols should comply with the

SOPs.

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VALIDATION DOCUMENTATION
Documentation that verifies each validation activity must be
generated and stored with the validation protocol in the
appropriate archive.

Validation documentation may include:

Test data
Summary reports
Procedures
Certification forms produced during the validation
process

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PRE-VALIDATION PROCESS
Before you can validate a system, you need
to identify the systems that require
validation.

Determining if a system requires validation

involves analysis of the following areas:
21 CFR Part 11 electronic records and
signatures;
Manufacturing processes;
Product [drug material] release or
stability information;
Regulatory information;
Support GxP activities.

All users must be trained on current SOPs

related to computer system development and
validation.
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VALIDATION MASTER PLAN
The validation of all computer systems will be
documented in a Validation Master Plan
(VMP)

The Validation Master Plan will include:

Identifying components requiring
validation
Prioritizing and justifying the
validations to be performed
All activities and assigned
responsibilities
Establishing site specific procedures
to support validation

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GAMP CATEGORIES

Category GAMP 4 GAMP 5

1 Operating System Infrastructure Software

2 Firmware NO LONGER USED

3 Standard Software Non-configured products

packages
4 Configurable software Configured products
packages
5 Custom (bespoke) software Custom products

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SPECIFICATION AND
QUALIFICATION RELATIONSHIPS

User
Requirement
Verifies PQ
Specification

Functional OQ
Verifies
Specification

Design
IQ
Specification Verifies

System Build

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THE VALIDATION PROCESS
Consists of five specific processes
Validation Master Plan (VMP)
Project Plan
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance or Process Qualification (PQ)

Planning Reporting

Specification Verification

Configuration and /
or coding

Supporting Processes including Risk Management

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VALIDATION PROCESS STEPS
Establish Teams
These are the teams that will be responsible for the validation process
Determine Validation Activities
Validation activities are the exact details or activities that will be required for each of the steps in the validation
process
The output from this activity will be the Validation Plan
Write the Validation Protocol
Describes the procedure and the steps within the procedure that will be followed in order to validate the system
The Validation Protocol must also provide a high level description of the overall philosophy, intention and
approach
Perform Qualification Activities
Design, IQ, OQ, PQ
Review Controls and Procedures
SOPs (Standard Operating Procedures)
Training procedures and Training records
Certify the System
This step is where you certify that the validation deliverables have met the
acceptance criteria that were described in the Validation Protocol
When you certify the system you should prepare a Validation Report
The validation report should outline the details of the validation process

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STEP 1 INITIAL RISK
ASSESSMENT
Based on business processes, user requirements, regulatory requirements and known
functional areas

Inputs Outputs
Step 1 Perform initial Risk Assessment and determine
system impact

User Requirements
GxP or non-GxP
Step 2 Identify Functions with Impact on Patient Safety,
Product Quality and Data Integrity
GxP Regulations
Major Risks
Step 3 Perform Functional Risk Assessments and Considered
Previous Assessment Identify Controls

Overall Risk
Step 4 Implement and Verify Appropriate Controls

Step 5 Review Risks and monitor Controls

Dont repeat Unnecessarily !

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STEP 2 IDENTIFY FUNCTIONS
WITH GxP IMPACT
Functions with impact on patient safety, product quality and data integrity

Inputs Outputs
Step 1 Perform initial Risk Assessment and determine
system impact
Specifications
Step 2 Identify Functions with Impact on Patient Safety, List of Functions to be
System Architecture Product Quality and Data Integrity further evaluated

Perform Functional Risk Assessments and

Categorization of Step 3
Identify Controls
Components
Step 4 Implement and Verify Appropriate Controls

Step 5 Review Risks and monitor Controls

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STEP 3 PERFORM FUNCTIONAL
RISK ASSESSMENTS & IDENTIFY
CONTROLS
Inputs Outputs
Step 1 Perform initial Risk Assessment and determine
system impact
Functions from step 2 Breakdown of Risks to
Low, Medium and
Step 2 Identify Functions with Impact on Patient Safety,
SME Experience Product Quality and Data Integrity High.

Scenarios Step 3 Perform Functional Risk Assessments and Detailed Assessments

Identify Controls
and Mitigation for
Possible Hazards High
Step 4 Implement and Verify Appropriate Controls

Step 5 Review Risks and monitor Controls

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TESTING DOCUMENTATION
Test Test Summary
Plan/Strategy Report

Test
Test
Protocol/Spe
Reports
cification

Test
Test Cases Test Scripts
Results

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FUNCTIONAL RISK ASSESMENT
Identify
Hazards and risk scenarios
Severity impact on safety quality or other harm
Probability
Detectability

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LEVERAGING SUPPLIER
INVOLVEMENT
Assess:
Requirements Gathering Suitability
Risk assessments
Accuracy
Functional / other Specifications
Configuration Completeness
Testing Flexibility:
Support and maintenance Format
Structure

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RESOURCES AND REFERENCES
Computer System Validation (FDA)
21 CFR Part 11
FDA Guidance for Industry
Computer Systems Used in GxP
Environment
Computer System Validation Its
More Than Just Testing
GAMP 5 A Risk Based Approach to
Compliant GxP Computerized
System
WHO-world Health Organisation
PIC/S-PHARMACEUTICAL
INSPECTION CONVENTION
EU GMP Annex 11

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 THANK YOU
TOGETHER WE CAN CREATE
Good business relation

For Technical queries:-

Email id: plcval@autocal.net
For service related queries
Visit us at or
get in touch on +91 250 2393 502/3/4

Branches:| Nashik | Pune | Vasai | Goa | Indore |

Hyderabad | Vapi | Vadodara | Sikkim| Baddi |

Providing services for Calibration/Validation/HVAC/PLC

(Accredited by NABL as per ISO / IEC 17025: 2005
for high precision calibration in
Mechanical [C-0915] & [C-1267],
Electro Technical [C-0916] & [C-1268]
Thermal [C-1409] & [C-1269] parameters)
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