An Overview on Challenges and Importance of Computer system Validation in Pharmaceutical Industry


Dhatchanamoorthi N, Raju Kamaraj

Department of Pharmaceutical Regulatory Affairs, SRM College of Pharmacy,

SRM Institute of Science and Technology, Kattankulathur-603203, Kanchipuram, Tamil Nadu, India.

*Corresponding Author E-mail:



In pharmaceutical industry, the regulatory compliance of computer system is increasing their importance. The regulation required to maintain a record for its safety, strength, efficacy, and quality for the substance. It establishing documented evidence to provide a high degree of assurance in a way of software or hardware which gives a fulfillment in line with the regulatory guidelines for certain industries mainly the 21 CFR part 820 and 21 CFR part 210 and 211 is applied to pharmaceutical product and is also applied to the medical device. The given life cycle model included the stage of 1. Planning, 2. Specification, 3. Programing, 4. Commissioning, 5. Testing, 6. Documentation, 7. Operating, 8. Monitoring and 10. Modifying. The V- Module supports structured testing it is very essential for successful validation. In this computer system validation content attach with the user requirement specification knowledge and a way to avoid a failure in computer system validation planning and many sources about this CSV are clearly discussed in this validation document.


KEYWORDS: Evidence commissioning documentation monitoring.




The computers are play a vital role in during a development and manufacturing of drug and the medial devices companies, this computer systems performed a major role to produce a reliability, security, consistency, accuracy of the data2. The CSV is giving the fundamental advantage like is to be reduce the human errors. CSV is system consists Product strength, purity, Quality. The U.S Code of federal regulation is focused on (GMP) Good manufacturing practice was inspected by food and drug regulation authority (FDA)Annexure 11 is composed to European agency to explained CGMP for its medicinal products.1-3


Regulatory background:

American code of federal regulation has following references, which related to the computer system validating process. This system is explained the regulatory viewpoint of computer system validation process4-5.


a)       Current good manufacturing practice for finished pharmaceuticals -21 CFR-part 211.68):

When the systems is automated, mechanical and electronic equipment or other types of equipment, including computer, or related system will be performed satisfied5, it may be used in the manufacturer, processing, packaging, and holding of a drug product when such equipment is so used, it shall be routinely calibrated, inspected or checked according to a written program. It is designed to be assured the proper performance. Written records and calibrated substance and inspected material should be maintained6.


b)      Good manufacturing practice for medical devices -21 CFR-part 820):

The mechanical, automa0074ed and electronic equipment placed in a quality assurance and a production area, it’s had capable for producing valid result. The computer is used at part of production and quality testing it’s should be admitted7. The variable computers software is used to validate so the adequate testing process are documented8.


c)       Good laboratory practice for non –clinical laboratory studies -21 CFR-part 58):

A automatic data collection system involves to identifies a data input on accurate time of data entry9. If any changes are made in automated entries it should be indicates a reason for the changes, it’s helps to notify a date and responsible individual can be identified.



This requirement is allowing expose the scope of this project. In a CSV system the computers need a variable accession to validate the process10. The system validation requirements and its developments structures are discussed below through the flow chart Fig 1.

·       Software, Hardware.

·       Controlling system and Equipment.

·       Operating system and documentation.

·       Controlled process and Total computerized system


Lifecycle module:

This software is creating under the lifecycle development bases (SDLC). It should be involved to validate the computer validation process11. Therefore, this model is applied as computers to evaluate each step of validation process12. In this development process the efficient documents which gets enabled. A brief overview of this model is given by “Augsburg et al. (1994).



The v-module is known as ‘Verification’ and ‘Validation’ module it is an SDLC module. The v-module is executing the process in sequential manner13. The v-module is getting an extension based on the association of testing phase for each corresponding development stage. This means that for every single phase is development cycle, it is directly associating with testing phase14. This is highly disciplined process development because the next phase starts only after completion of the previous phase15.


In this phase like design specification, code development and code testing are not necessary. This module comprises of user requirements specification (URS) that is, Design qualification (DQ), Installation qualification (IQ), Operational qualification (OP), Performance qualification (PQ)15


Fig 2: V model


Reason for failures of computer system validation:

Without adequate and planning and preparation, computer system validation can encounter several problems, eventually leading to failure of the process16. The problems are included.

a)     Insufficient documents and planning.

b)    Insufficient definition of constitutes in CSV.

c)     Insufficient definition of expected results.

d)    Insufficient specification of software.

e)     Software does not meet is specification.

f)     Inadequate source code for software.


Various validations planning for avoiding a failure in computer system validations:

Computer system validation begin at the beginning of the system designed .it begins and goes through a complete SDLC. Various stages in computer system validation as follows


Master validation plan:

·       Identifies of the parties’ responsibility for different parts of program

·       Report of the equipment, and assay to be validated

·       Determination acceptance of criteria for each system, process to be validated.

·       Defining all SOP’s.


User Requirement Specification:

The user requirement specification is elaborately explained it status. Then the user what they do it. Its traits to having the detail about then on-functional requirement and restraints17.

The following criteria should be considered.

·       Operation data is required.

·       Programming standards and test procedure are developed.

·       Integral groups are assigned project responsibility/ scheduled.

·       System aces security.

·       Data handling and reporting.

·       Supplier supporting documentation and testing.

·       Utilization of Standard operating procedure (SOP’s)18.


Design Qualification:

DQ is made both hardware as well as software.19 The hardware portion of the system description is prepared in text and chart formats. These documents provide signal, data, and process flow details. Some are hardware components

·       Controller.

·       Peripheral device.

·       Networking modules and cabling

·       Input and Output modules.

·       Power requirements.

·       Enclosures etc.


For software the DQ is assigned as

·       Operating system software.

·       Configuration system software.

·       Application specification system software.


Installation Qualification:

IQ confirmed the computer system after received it designed and specified software, that is properly installed in the selected computerised system20-24. This is suitable for the selected environment and attached with this operation and use of these instruments.


A manufacture’s recommendation for installation is requires and then checking for fulfilments of the manufacture requirements before installation procedure is stated.


Before Installation:

·       Electricity.

·       Water and gases.

·       Humidity and temperature.

·       Vibration level and Dust level.

·       SOP’S.

·       Operating manual, logbooks and software.

·       Grounding, termination and tagging.

·       Control cabinets and environmental condition.

·       Purchase order.

·       Specification

·       Manuals.

·       Spare part lists.


Operational Qualification:

OP in each protocol has met the IQ phase, OP is involved to check the equipment performance and it consists with user requirements specification and within a manufacturing specific range25.


In the OQ phase, all test phase is tested individually, and their performance are documented26.


This is the precheck process involved in this technical acceptance for the equipment and its facility, it can be performed only after the installation of IQ has successful.

·       Temperature controls and fluctuations.

·       Pressure / vacuums controlling system.

·       CO2 controlling system.

·       Display unit and signalling led.

·       Fan and its speed controllers.

·       Card reader and access control.

·       Overheating and low temperature protecting systems and access.

·       Motors and air flap controllers.


Performance Qualification:

PQ process is the final stage in equipment quality checking process and these stags itself to verify the documenting on a equipment working and its reproducibly within a specified working range27.


According to the user needs the complexity of the system, performance qualification can be combined by installation qualification or operational qualification28. Due to this qualification the data should be prepared before the equipment test qualification is running. Every equipment is tested individually and checks according to the tested plan based on the process description29-30.

·       Running checks.

·       Software installation verification.

·       Backups and restoration.

·       Alarm, event, measuring and handling.

·       Data records and reports.

·       Control and monitoring loop operation.

·       Power loss and recovery.

·       System access security.



Computer system validation in a pharmaceutical industry play a successful role in both quality management or quality assurance system, a formal system Development life cycle (SDLC) and qualification task performed throughout the SDLC. The CSV fulfil the all requirements and user expectation. The V model of SDLC and the requirements of computer system validation is clearly elaborated in this CSV system. In this system the methodologies of the required specification and test protocols are written, and its approval process is explained and then the validation methodology also be included28. In this system specially included the reason for failure in CSV system and how it’s should be solved during the CSV in industries are also be given its is very helpful to gain a elaborate knowledge about the CSV computer system validation.



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Received on 12.02.2020           Modified on 08.04.2020

Accepted on 29.05.2020         © RJPT All right reserved

Research J. Pharm. and Tech. 2020; 13(11):5591-5594.

DOI: 10.5958/0974-360X.2020.00975.0