The document outlines computer system validation (CSV) as a process to ensure that computer systems consistently produce results that meet predetermined specifications and quality attributes. It details various steps in the validation process, including planning, user requirements, vendor assessment, and different CSV models, along with specific examples such as HPLC software validation. The importance of risk assessment and ongoing validation throughout the system lifecycle is emphasized, alongside guidelines for effective vendor assessment.

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COMPUTER SYSTEM
VALIDATION
Prepared By- Miss Chitralekha Sonawane
Guided By- Dr. Mrs. S. P. Mahaparale

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Contents
• Validation
• Computer System
• Principle of CSV
• Steps of Validation
• CSV Models
• Vendor Assessment
• Example- HPLC Software

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Validation
Establishing documented evidence that
provides a high degree of assurance that a
specific process will consistently produce a
product meeting its pre-determined
specifications and quality attributes.

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COMPUTER SYSTEM

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Background
 In 1987 the FDA published a document entitled
‘FDA Guidelines on General Principles of
Process Validation’.
 Definition of validation indicates that validation
can apply to any process including process
managed / controlled by computer systems.

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Computer System
Validation
Establishing documented evidence which
provides a high degree of assurance that
a computer system will consistently
produce results that meet its
predetermined specification and quality
attributes.

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Principle of CSV
 Validation of computer systems is not a one time
event.
 All publications refer to some kind of life cycle
model with a formal change control procedure
being an important part of the whole process.
 There are no detailed instructions on what
should be tested. All guidelines refer to risk
assessment for the extent of validation

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Steps of Validation
 Validation planning
 Defining user requirements
 Functional specifications
 Design specifications
 Validation during development
 Vendor assessment for purchased systems,
installation
 Initial and ongoing testing and change control

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CSV Model
• V-Lifecycle model
• 4Q Lifecycle model
• System Integration combined with system
development

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V-Lifecycle model

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4Q Lifecycle model

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System Integration combined with
system development

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Vendor Assessment
Objective- To get assurance that the vendor’s
products development and manufacturing
practices meet the requirements of the user’s
firm for quality.
• Documentation of experience with the vendor.
• External references
• Assessment checklists (mail audits)
• 3rd party audits
• Direct vendor audits

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Rating for Vendor
Assessment
Rating Meaning Interpretation
3 Excellent
Vendor procedures and practices are
above average
2 Adequate
Vendor procedures and practices are
about average
1 Poor
Vendor procedures and practices are
below average and need to be
improved
0 Unsatisfactory
Vendor procedures and practices are
unacceptable
N/A Not Applicable
Question is not applicable to the type
of function or service

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Example
• Validation of HPLC Software

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User Requirement
Specification Requirement of injection volume, Flow rate, run
time, column temperature, wavelength etc.
 Requirement related to the injection, selection of
vials, sequence copy and paste etc.
 Printing facility.
 System should be capable to run single injection
or sequence of injection.
 System should be capable to control user access
right.

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Design Qualification
 URS
 Inspection of computer hardware- CPU, on/off
switches.
 Operating system configuration- Processor,
hard disc memory.
 Workstation configuration- Instrument name,
model, software version.

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Installation
Qualification Compare system with purchase order.
 Check all documents.
 Check the system for any damage.
 Install by connecting all components.
 Switch on the system.
 Install software.
 Configure printer and other equipments.
 List all manuals and SOPs related to equipment.
 Prepare report.

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Operation
Qualification
 Computer System Qualification
 Software Qualification

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Computer system
Qualification
• Computer boot up check.
• Date and time check
• Hard disc check
• Print drive check
• Net work connection check
• Software version check

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Software Qualification
 Workstation software
Access control point
Password policies
Audit trail check
 Application software functionality
Method preparation check
Method edit/delete control check
Post analysis process, reprocess check

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Reference
 Dr. Sohan Chitlange, Dr. P. D. Choudhary, Mr. A. E. Shirsat,
Dr. J. N. Snghshetti. “Pharmaceutical Validation” 2014. Suyog
Publication, pp- 8.1-8.11.
 General Principles of Software Validation, U.S. Food and
Drug Administration, January 11, 2002.
 Atul Bendale, Nirav Patel, D. P. Damahe, Sachin B.
Narkhede, Anil G. Jadhav, G. Vidyasagar. Computer Software
Validation In Pharmaceuticals. Asian Journal of
Pharmaceutical Sciences and Clinical Research (AJPSCR)
Vol. 1, Issue 2 (2011), 27-39.
 Ankur Choudhari. Computer Software Validation In
Pharmaceuticals. Pharmaceutical Guidelines.

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