Computer system validations
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The document provides an overview of Computer System Validation (CSV), detailing its importance in ensuring software, hardware, and processes comply with regulatory standards like 21 CFR Part 11 and GAMP 5. It outlines the processes involved in CSV, including quality planning, user requirement specifications, and risk assessment, emphasizing the need for systematic testing and implementation. The document highlights the critical role of CSV in ensuring patient safety, product quality, and data integrity within various applications, especially in the medical and laboratory sectors.
Computer system validations
- 1. 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 [email protected] 1
- 2. COMPUTER SYSTEM VALIDATION Presented by : Saikiran Koyalkar [email protected] 2
- 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] 3
- 4. VALIDATION • Method – Method validation • Process – Process validation • Cleaning – Cleaning validation • Computers and software - Computer System Validation (CSV) • Etc… Presented by : Saikiran Koyalkar [email protected] 4
- 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] 5
- 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 [email protected] 6
- 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 [email protected] 7
- 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] 8
- 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] 9
- 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] 10
- 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] 11
- 12. 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 Presented by : Saikiran Koyalkar [email protected] 12
- 13. 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) Presented by : Saikiran Koyalkar [email protected] 13
- 14. 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 Presented by : Saikiran Koyalkar [email protected] 14
- 15. 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. Presented by : Saikiran Koyalkar [email protected] 15
- 16. 3) DESIGN AND DEVELOPMENT OF SOFTWARE AS PER URS Presented by : Saikiran Koyalkar [email protected] 16 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
- 17. 3) DESIGN AND DEVELOPMENT OF 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) Presented by : Saikiran Koyalkar [email protected] 17
- 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] 18
- 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. • If any user requirement / regulatory requirement not meeting, Initiation of CAPA and reworking on the development to meet the requirements. Presented by : Saikiran Koyalkar [email protected] 19
- 20. 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. Presented by : Saikiran Koyalkar [email protected] 20
- 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] 21
- 22. 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. Presented by : Saikiran Koyalkar [email protected] 22
- 23. 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 Presented by : Saikiran Koyalkar [email protected] 23
- 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] 24
- 25. Thank you Presented by : Saikiran Koyalkar [email protected] 25