Computer system validations

COMPUTER SYSTEM
VALIDATION (CSV)
Reference:
• General principles of software validation; Final Guidance for industry and
FDA Staff
• GAMP 5
• 21 CFR Part 11
Presented by : Saikiran Koyalkar
Saikiran.kiran78@gmail.com
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COMPUTER SYSTEM VALIDATION
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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.
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VALIDATION
• Method – Method validation
• Process – Process validation
• Cleaning – Cleaning validation
• Computers and software - Computer System Validation (CSV)
• Etc…
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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.
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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 )
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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)
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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
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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
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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
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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..)
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1) QUALITY PLANNING
What are the Quality System Requirements ?
Eg: LIMS
• Traceability of each activity from where that information received ( TRF’s,
Parameter’s, method’s, Customer’s data base etc..)
• Who Received, When received (Electronic signatures , Audit Trails, Access
controls)
• What kind of Information Received (Sample information, tests, methods
etc..)
• What kind of information Generated (Raw data for testing, Test reports
etc..)
• Who, When, What – Generated
• Trend analysis of Data
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2) USER REQUIREMENTS SPECIFICATIONS
User should define what output he/she required from the particular
software
Eg: For LIMS
• Customer Database
• Test parameters, Methods, Specifications – packages
• Sample Receipt and Registration
• Sample analysis and Data Entry
• Report Generation
• Report and Data review , authorization ( Electronic Signatures)
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2)USER REQUIREMENTS SPECIFICATIONS
• Report Release
• Trend analysis of data
• Access controls ( User ID, Passwords , Audit Trails)
• Avoid duplication of activities
• Risks Associated with Specific functions
• Do’s and Don'ts of Software
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3) DESIGN AND DEVELOPMENT OF
SOFTWARE AS PER URS
Essential requirements for development of Software :
• Clear understanding of users requirements and regulatory requirements.
• Development the Software as per the requirements.
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SOFTWARE AS PER URS
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GAMP 5 Software Categories
1)Infrastructure Software
Eg: Operating system, Anti-virus (windows, Programming Languages,
Spread sheets packages)
2) Firmware - It is Discontinued now it is treated as category 3, 4 5

SOFTWARE AS PER URS
3) Standard Software
Ready developed and available software's in market- which will not
allow changes in software according to user requirements
4) Configured software
(Ready developed and available software's in market- which will allow
changes in software according to user requirements)
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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.
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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.
• If any user requirement / regulatory requirement not meeting,
Initiation of CAPA and reworking on the development to meet the
requirements.
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5)Quality Risk Assessment of Developed
Software – Risk Based Approach
• 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.
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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
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7) TESTING & IMPLEMENTATION AT USER
FACILITY
• Installation of developed software at customer facility (Lab /
Manufacturing / User Facility)
• Testing the software as per the each user requirement specification and
regulatory expected output.
• Training the employees on the Qualified software for regular use.
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8) Bugs identification (Minor Errors) Fixation
& Support
• If any bugs (Minor problems ) which does not affects the quality
outputs, data integrity, Quality outputs and meet the User requirements
and regulatory requirements should be fixed.
• Continuous support of developer for fixing of Bugs
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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
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Thank you
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Computer system validations

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