Computer system validations

This Presentation gives an idea about validation and different type of validation and overview of computer system/software validation and basics steps for computer system validations as per the regulatory and user requirement specifications.

1. COMPUTER SYSTEM
VALIDATION (CSV)
Reference:
•Generalprinciplesofsoftwarevalidation;FinalGuidanceforindustryand
FDAStaff
•GAMP5
•21CFRPart11
Presented by : Saikiran Koyalkar
[email protected]
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2. COMPUTER SYSTEM VALIDATION
Presented by : Saikiran Koyalkar
[email protected]
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3. COMPUTER SYSTEM VALIDATION
What is Validation:
Validation is the process of establishing documentary evidence
demonstrating that a procedure, process, or activity carried out in testing
and then production maintains the desired level of compliance at all
stages.
In simple words -
Valid = Validity ation= process
It is the process of checking the validity of any procedure, process and
activity with the documentary evidence.
Presented by : Saikiran Koyalkar
[email protected]
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4. VALIDATION
•Method –Method validation
•Process –Process validation
•Cleaning –Cleaning validation
•Computers and software -Computer System Validation (CSV)
•Etc…
Presented by : Saikiran Koyalkar
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5. WHY VALIDATION ?
•It is a proof of correctness of process / method/ any activity delivering
the consistent , reliable, accurate output
•Process of making official and legally acceptable.
Presented by : Saikiran Koyalkar
[email protected]
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6. WHAT IS COMPUTER SYSTEM
VALIDATION ?
•CSV is the process of ensuring that any technology component
(software or hardware ) is fulfilling its purpose in line with the
regulatory requirements ( 21 CFR Part 11, GAMP 5 )
Presented by : Saikiran Koyalkar
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7. CSV -APPLICABILITY
•It is applicable to software used in production, Manufacturing, testing,
and software used as components in medical devices, to software that
itself a medical device.
•Any Software used to automate any part of the device production
process / testing (eg: Computerized systems HPLC, GC, IC, ICP-MS
etc..) or any part of quality system
•Computer systems used to create, modify and maintain electronic
records and to manage electronic signatures (LIMS and any other
document management system software)
Presented by : Saikiran Koyalkar
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8. WHY CSV ?
•To achieve computerized systems that are fit for intended use and meet
current regulatory requirements, by building upon existing industry
good practice in an efficient and effective manner
•Patient safety, Product Quality and Data Integrity
•It is a Critical tool used to assure the quality of software and software
automated operations.
Benefits :
•Decrease the failure rates
•Increase usability and reliability of software for specific Operation
•Decrease the recalls and corrective actions
•Less Risk to Patients and Users
Presented by : Saikiran Koyalkar
[email protected]
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9. CSV VALIDATION
CSV is dependent on the complexity of the project, it can be into following
processes
1) Quality Planning
2) User Requirement Specification ( URS) / Software Requirement
Specification
3) Design and Development of Software as per URS
4) Verification Individual Process of Developed Software against URS
(Testing)
5) Quality Risk Assessment of Developed Software –Risk Based Approach
6) Backup Planning and Change Management
Presented by : Saikiran Koyalkar
[email protected]
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10. CSV VALIDATION
7) Testing and Implementation at User Facility
7.1 Installation Qualification ( IQ)
7.2 Operational Qualification (OQ)
7.3 Performance Qualification (PQ)
7.4 Retirement / Making Live for Implementation
8) Bugs identification (Minor Errors ), Fixation & Support
Presented by : Saikiran Koyalkar
[email protected]
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11. 1) QUALITY PLANNING
For which activity Software driven process required
Eg:
1) Laboratory Information Management System (LIMS)
Software driven process for handling and Management of information
received and produced in the laboratory
2) Accounts and Taxation (SAP, ORACLE)
Software for Management of accounts (credits, Debits, Employee
Salaries, Purchase orders, Loans etc..)
Presented by : Saikiran Koyalkar
[email protected]
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12. 1) QUALITY PLANNING
WhataretheQualitySystemRequirements?
Eg:LIMS
•Traceabilityofeachactivityfromwherethatinformationreceived(TRF’s,
Parameter’s,method’s,Customer’sdatabaseetc..)
•WhoReceived,Whenreceived(Electronicsignatures,AuditTrails,Access
controls)
•WhatkindofInformationReceived(Sampleinformation,tests,methods
etc..)
•WhatkindofinformationGenerated(Rawdatafortesting,Testreports
etc..)
•Who,When,What–Generated
•TrendanalysisofData
Presented by : Saikiran Koyalkar
[email protected]
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13. 2) USER REQUIREMENTS SPECIFICATIONS
Usershoulddefinewhatoutputhe/sherequiredfromtheparticular
software
Eg:ForLIMS
•CustomerDatabase
•Testparameters,Methods,Specifications–packages
•SampleReceiptandRegistration
•SampleanalysisandDataEntry
•ReportGeneration
•ReportandDatareview,authorization(ElectronicSignatures)
Presented by : Saikiran Koyalkar
[email protected]
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14. 2)USER REQUIREMENTS SPECIFICATIONS
•ReportRelease
•Trendanalysisofdata
•Accesscontrols(UserID,Passwords,AuditTrails)
•Avoidduplicationofactivities
•RisksAssociatedwithSpecificfunctions
•Do’sandDon'tsofSoftware
Presented by : Saikiran Koyalkar
[email protected]
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15. 3) DESIGN AND DEVELOPMENT OF
SOFTWARE AS PER URS
EssentialrequirementsfordevelopmentofSoftware:
•Clearunderstandingofusersrequirementsandregulatoryrequirements.
•DevelopmenttheSoftwareaspertherequirements.
Presented by : Saikiran Koyalkar
[email protected]
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16. 3) DESIGN AND DEVELOPMENT OF
SOFTWARE AS PER URS
Presented by : Saikiran Koyalkar
[email protected]
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GAMP5SoftwareCategories
1)InfrastructureSoftware
Eg:Operatingsystem,Anti-virus(windows,ProgrammingLanguages,
Spreadsheetspackages)
2)Firmware-ItisDiscontinuednowitistreatedascategory3,45

17. 3) DESIGN AND DEVELOPMENT OF
SOFTWARE AS PER URS
3)StandardSoftware
Readydevelopedandavailablesoftware'sinmarket-whichwillnot
allowchangesinsoftwareaccordingtouserrequirements
4)Configuredsoftware
(Readydevelopedandavailablesoftware'sinmarket-whichwillallow
changesinsoftwareaccordingtouserrequirements)
Presented by : Saikiran Koyalkar
[email protected]
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18. 3) DESIGN AND DEVELOPMENT OF
SOFTWARE AS PER URS
5) Custom Software
•These software are developed to meet the specific needs of business
processes.
Eg: LIMS
•Risk involved in this custom software is high & Impact of errors are
greater
•For this custom software rigorous verification/ testing required to
ensure no impact on data integrity, reliability and Quality out put data.
Presented by : Saikiran Koyalkar
[email protected]
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19. 4) VERIFICATION INDIVIDUAL PROCESS OF
DEVELOPED SOFTWARE AGAINST URS
(TESTING)
•Verification should be done against the each URS and regulatory
requirements for each activity of process.
•Ifany user requirement / regulatory requirement not meeting,
Initiation of CAPA and reworking on the development to meet the
requirements.
Presented by : Saikiran Koyalkar
[email protected]
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20. 5)QualityRiskAssessmentofDeveloped
Software–RiskBasedApproach
•Identify the risks in the developed software
•Impact assessment of risk identification ( Major and Minor)
•Actions (CAPA) against the major risks identified which impact the
data integrity, safety and Quality of data output.
Presented by : Saikiran Koyalkar
[email protected]
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21. 6) Backup Planning and Change Management
•Disaster management like data loss due to sudden electric failures and
Hard disc crash etc…
•Data Backup
•If any Minor problem –Initiation for modification or changes in the
software through change control procedures
Presented by : Saikiran Koyalkar
[email protected]
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22. 7) TESTING & IMPLEMENTATION AT USER
FACILITY
•Installationofdevelopedsoftwareatcustomerfacility(Lab/
Manufacturing/UserFacility)
•Testingthesoftwareaspertheeachuserrequirementspecificationand
regulatoryexpectedoutput.
•TrainingtheemployeesontheQualifiedsoftwareforregularuse.
Presented by : Saikiran Koyalkar
[email protected]
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23. 8) Bugs identification (Minor Errors) Fixation
& Support
•Ifanybugs(Minorproblems)whichdoesnotaffectsthequality
outputs,dataintegrity,QualityoutputsandmeettheUserrequirements
andregulatoryrequirementsshouldbefixed.
•ContinuoussupportofdeveloperforfixingofBugs
Presented by : Saikiran Koyalkar
[email protected]
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24. 8) Bugs identification (Minor Errors) Fixation
& Support
•If any error which affect the quality output, data integrity and safety
should be immediately fixed by redevelopment of specific process to
meet the requirements without impacting Data integrity, Quality
outputs, safety
Presented by : Saikiran Koyalkar
[email protected]
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25. Thank you
Presented by : Saikiran Koyalkar
[email protected]
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