Computer System Validation A Review
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Editor IJTSRDComputer System Validation A Review
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Editor IJTSRDInternational Journal of Trend in Scientific Research and Development (IJTSRD)
Volume 7 Issue 2, March-April 2023 Available Online: www.ijtsrd.com e-ISSN: 2456 – 6470
Computer System Validation: A Review
Megha S. Jadhav1, Dr. Prashant S. Malpure2, Prathamesh G. Pawar1,
Rajratna S. Pawar1, Sanket C. Pawar1
1
Department of Pharmaceutical Chemistry, Matoshri College of Pharmacy, Nashik, Maharashtra, India
2
Departments of Pharmaceutics, Matoshri College of Pharmacy, Nashik, Maharashtra, India
ABSTRACT How to cite this paper: Megha S. Jadhav
Computer System validation it will be also the equipment those are | Dr. Prashant S. Malpure | Prathamesh
having their based upon the Control management of Software System. G. Pawar | Rajratna S. Pawar | Sanket C.
Computer system validation provides recognized proof that the Pawar "Computer System Validation: A
systems will regularly and consistently do what it is deliberate to do, Review" Published
in International
is "fit-for-purpose", and complies with the applicable rules and
Journal of Trend in
regulations. The objective of computer systems includes systems used Scientific Research
to management of data or support decision making subject to review and Development
by regulated authorities whether they are being submitted because its (ijtsrd), ISSN: 2456-
impact on quality or safety on business validation assessment program 6470, Volume-7 | IJTSRD55108
is a necessity in the pharmaceutical industry to ensure adherence to Issue-2, April 2023,
pharmaceutical current good manufacturing practices guidelines, and pp.711-715, URL:
to help companies maintain quality of product. Computer system www.ijtsrd.com/papers/ijtsrd55108.pdf
validation to a computer system or an information technology
management. It will be essential to maintain quality standards in Copyright © 2023 by author (s) and
International Journal of Trend in
pharma since non-conformance can have far-reaching consequences.
Scientific Research and Development
Aims to identify needs of computer system validation of instrument Journal. This is an
practiced in the perspective of pharmaceutical industry. Open Access article
KEYWORDS: Computer System Validation, Good Automated distributed under the
terms of the Creative Commons
Manufacturing Practices, Validation, cGMP
Attribution License (CC BY 4.0)
(http://creativecommons.org/licenses/by/4.0)
INTRODUCTION
Computer System Validation and provides an manufacturing facilities spending more time
overview of CSV methodologies and a road map of documenting than testing. Traditional CSV
the deliverables used in the CSV process on methodologies can see manufacturers spending up to
pharmaceutical IT Companies. As computer systems 80% of their time documenting processes, and only
are diverse, depending upon size of management 20% of time testing the efficacy of the solutions.
system, novelty, complexibility and business impact,
Computer System Validation:
the deliverables may be scaled up or down Validations of computer systems that manage
accordingly. The CSV process discussed in this
processes, organize systems, collect analytical data,
whitepaper is based on the GAMP 5 framework, as it and carry out analytical test procedures. Computer
provides an excellent and rapid approach for CSV
system validation includes the qualification of all
which, when followed, they ensure your software & hardware of quality management system,
computerized systems are fit for purpose, will meet
which has impact (Directly/Indirect) on the quality of
the needs of your business, and are compliant with a product. The purpose of the validation process is to
current regulations. The Life Science industry has a
provide a high degree of assurance that a specific
strong legacy of Validating Computer Systems process will consistently produce a product (control
thoroughly. However, the traditional ‘test everything information or data) which meets predetermined
approach’ has become outdated and leaves GMP specifications and quality attributes.
@ IJTSRD | Unique Paper ID – IJTSRD55108 | Volume – 7 | Issue – 2 | March-April 2023 Page 711
International Journal of Trend in Scientific Research and Development @ www.ijtsrd.com eISSN: 2456-6470
Fig: Life Cycle of Computer System Validation
1. Concept Phase:
In the concept phase also include in the Software and Hardware of management system Categorization to
establish the validation approaches and determination of the deliverables:
Cat 1 – Infrastructure modeling Software
Cat 2 – Non-Configuration system
Cat 3 – Configuration System
Cat 4 – Customization of applied branches
Hardware Cat 1 – Excellent Hardware objectives
Hardware Cat 2 – Customization of Build Hardware objectives.
2. Project Phase:
The system supplier must be assessed to determination of their suitability to provide a quality system that me
Risk Management. it will be should performed at various key stages of the validation process by
multidisciplinary team so that a full understanding of all processes and requirements are covered and considered.
3. Operation Phase:
The CSV Is in coming in operation. It’s Maintain the validation status, all aspects of the system and operating
environment must be kept in a documented state of control.
4. Retirement Phase:
Retired from operational service so that the process is documented and controlled.
What is Validation?
“Validation is the documented evidence which provides a high degree of assurance that specific process will
consistently produce a product meeting its predetermined specifications & quality characteristics”. Validation is
a very vital part of quality assurance which gives confirmation of the quality in the equipment, manufacturing
process, software & testing. Validation assures that products with specific quality characteristics & attributes can
be produced constantly within given limits of manufacturing process. Validation is bridge to move the product
from development to commercial production.
Types of Validation:
Process validation
Equipment validation
Facilities validation
HVAC system validation
Cleaning validation
Analytical method validation
Computer system validation
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International Journal of Trend in Scientific Research and Development @ www.ijtsrd.com eISSN: 2456-6470
Computer System Validation Process:
Figure 2: Model of Computer System Validation
1. Infrastructure Qualification – documentation showing that the network and infrastructure
hardware/software supporting the application system being validated has been installed correctly and is
functioning as intended.
2. Installation Qualification (IQ) – test cases for checking that system has been installed correctly in user
environment.
3. Operational Qualification (OQ)–test cases for checking that system does what it is intended to do in user
environment.
4. Performance Qualification (PQ)–test cases for checking that System does what it is intended to do with
trained people following SOPs in the production environment even under worst case conditions
Objective of Computer System Validation:
1. Accuracy
2. Reliability
3. Consistency
4. Regularity
5. The integrity of the e-records
Project Plan:
The project plan outlines what is to be done in order to get a specific system into compliance. For inspectors, it is
a first indication of the control a laboratory has over a specific instrument or system and it also gives a first
impression of the qualification quality. Documentation and training on the standard operating procedures (SOPs)
is carried out.
@ IJTSRD | Unique Paper ID – IJTSRD55108 | Volume – 7 | Issue – 2 | March-April 2023 Page 713
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Figure 3: Project Plan
A detailed documentation and training on the standard operating procedures (SOPs) is carried out during this
process.
Equipment’s and Computer Validation Master 5. Processes
Plan Include: Processes involved in GMP refer to the
1. Validation Plan documentation that is used to prove that procedures
2. Change Control are being followed.
3. Risk Assessment
4. Design Qualification
5. Installation Qualification
6. Operational Qualification
7. Performance Qualification
8. Traceability Matrix and Report.
Good Manufacturing Practices of Validation:
1. Primary Materials and Products
Primary materials are the raw ingredients used to
create a product, which is the end result that is sold to
consumers. If the primary materials are not of the
utmost quality, flaws can occur in the end result.
2. Premises
Laboratories are the backbone of pharmaceutical
manufacturing and must be properly maintained.
3. People Figure 4: Component of Good Manufacturing
People are the backbone of any business, and that’s Practices Validation
no different in pharmaceutical manufacturing. Having
trained people operating each facility is required in Need of Computer System Validation:
order to remain cGMP compliant. 1. It minimizes the risk of preventing problems &
thus assures the smooth running of the process.
4. Procedures 2. Validated process is more efficient & produces
A manufacturer’s procedures will be scrutinized when less reworks, rejects & wastage.
audited. All procedures must be regularly revisited to 3. Validated process may require less in-process
ensure that they are making use of the latest controls & end product testing.
technology and science involved in pharmaceutical 4. It minimizes risk of defect cost & risk of
manufacturing. regulatory noncompliance.
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Cares About Computer System Validation: [2] CFR, 21 CFR, Part 211: Current Good
Resources involved in any way with IT, computer Manufacturing Practice for Finished
or automated systems is affected: Pharmaceuticals, sections 21 I. 22: Proposed
Developers Rules, vol. 61.Federal Register, pp., 1996;
Maintainers 20104-20115.
Users [3] Sharon Strause ―Computer System
Regulatory Authorities Validation—Definition and Requirementsǁ
QA
Originally published in the spring 2009 issue of
Future of Computer System Validation: Journal of Validation Technology, pp-1-5
These regulatory agencies require CSV processes to
[4] Products, Document PH 1/97 (Rev. 3), PIC/S
confirm the accuracy and integrity of data in
Secretariat, 9-11 Rue de Varem be, CH-1211
computerized systems in order to ensure product
Geneva 20
safety and effectiveness.
[5] Dr. Sohan S. Chitlange, Dr. pravin D.
1. Develop Clear and Precise Functional and Chaudhari, Mr. ajinath E. Shirsath, Dr.
User Requirements - One of the biggest
Jaiprakash N. Sangshetti, ―pharmaceutical
mistakes companies make when starting an
validationǁ first edition, suyog publication and
informatics project is to not do the strategic distributors pvt.Ltd. 8.1-8.11
planning necessary to ensure success.
[6] Kaner, Cem, Falk, Jack, Nguyen, Hung Quoc,
2. Perform risk-based CSV - CSV takes a lot of
Testing Computer Software, New York: John
time and IT resources to accomplish, so it is wise Wiley & Sons; 1999.
to follow a flexible approach that utilizes a risk-
based assessment on the system to determine [7] Potdar M.A, cGMP for Pharmaceuticals,
required test cases and the optimal level of testing Pharmaceutical Validation, 3rd edition, Nirali
for each. prakashan, Pune, 437 – 450.
3. Good Validation Plan - Like any technical [8] FDA, draft of Guidance for the Industry: 21
endeavor, CSV processes should be guided by a CFR Part 11; Electronic Records; Electronic
good plan that is created before the project starts. Signatures: Glossary of Terms, August 2001.
CONCLUSION [9] FDA CDRH, General Principles of Software
Computer system validation is an important part of Validation; Final Guidance for Industry and
confirming the accuracy and integrity of your data, FDA Staff, January 2002.
along with ensuring product safety and effectiveness. [10] Giridhar A, Hamdan I, Joglekar G,
Effective, risk-based validation of computerized Venkatasubramanian V, Reklaitis GV, Real-
systems is also an important part of maintaining time process management in particulate and
regulatory compliance. Inefficient or ineffective CSV pharmaceutical systems, Computer Aided
processes prevents projects from being delivered on Chemical Engineering, 2011; 29:1035–1039.
time and within budget and may also result in
regulatory action that can be legally and financially [11] Ludwig Huber,’ Analytical Instrument
devastating to an organization. Validation Master Qualification and System Validation’, Agilent
Plan defines computerized system validation strategy. Technologies, 2009, Publication Number 5990-
System Assessment represents the actual 3288EN, pp-40-44.
documentation quality status of the system. [12] Bedson P, Sargent M, The development and
REFERENCES application of guidance on equipment
[1] Andreas Hoffmann, Jacqueline IGihny- qualification of analytical instruments,
Simonius, Marcel Plattner, Vanja Accreditation and Quality Assurance, 1996;
SchmidliVckovski, Christian Kronseder, 1(6):265-274.
―Computer system validation: An overview of [13] Robert Nash and Alfred Wachter, Marcel
official requirements and standardsǁ, Decker, Pharmaceutical Process Validation, 3rd
Pharmaceutics Acta Helvetiae., 1998; 72: 317- Ed. Edited by, 2003, pp.507-509
325.
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