Software Validation and Testing

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Software Validation and Testing

  1. 1. www.mips.b e Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008
  2. 2. www.mips.b e Agenda MIPS Company Products MIPS product development process Defect prevention Defect correction Q&A
  3. 3. www.mips.b e We offer Solutions to improve the efficiency of clinical laboratories Based on Standardized Software and Customized Services and Support to meet specific customer requirements
  4. 4. www.mips.b e Group Operating structure . MIPS CliniSys Europe UK & Ireland
  5. 5. www.mips.b e Group Global Coverage – Local Delivery Over 850 Sites Using CliniSys’ Solutions 200 Dedicated Healthcare IT Professionals Supporting 100,000 Healthcare Professionals
  6. 6. www.mips.b e Clinisys : Pan-European Group  Development Centre:  Chertsey(Clinisys)  Glasgow(Clinisys)  Gent (MIPS)  Sales and Support Offices: Glasgow  Clinisys Chertsey Chertsey Hamburg Hamburg  Glasgow (Scotland) Gent Gent  Chertsey (England) Paris Paris  MIPS  Gent (Belgium)  Hamburg (Germany) Madrid Madrid  Paris (France)  Madrid (Spain)
  7. 7. www.mips.b e Agenda MIPS Company Products MIPS product development process Defect prevention Defect correction Q&A
  8. 8. www.mips.b e MIPS products  Glims Laboratory information system (LIS)  Samplenet Data manager  Cyberlab Result consultation via Intranet / Internet and electronic order entry  Drivers Interface with IVD MD and HIS  Archie XML Archiving
  9. 9. www.mips.b e Specialised in large complex IT-solutions for clinical laboratries Connection with hospital information system Direct bidirectional connections Remote result consultation Data Manager or Concentrators LIS Remote order entry Laboratory clients
  10. 10. www.mips.b e Cyberlab  Web based Result consulting and Order entry system  Real-time result consultation for wards /outpatient clinics/GP  Electronic order entry for wards / outpatient clinics / GP  Reporting management  Can be interfaced with any LIS  Can be integrated in an EPR  Better interaction between the lab and its end users  Better service for hospital
  11. 11. www.mips.b e Specialised in large complex IT-solutions for clinical laboratories Connection with hospital information system Direct bidirectional connections with analyzers Drivers Remote result consultation Data Manager or Concentrators LIS Remote order entry Laboratory clients
  12. 12. www.mips.b e GLIMS covers following labs:  Biochemistry  Toxicology  Immunology  Blood transfusion  Epidemiology  HLA / Histocompatability  Microbiology  Bacteriology – Parasitology – Serology - Virology  Hematology and coagulation  Anticoagulants treatments  Immuno-hematology  Statistics :  Microbiology - Activity - Financial -Blood transfusion - Histology
  13. 13. www.mips.b e Leading European LIS Supplier  Market leader in Netherlands (50+) and Belgium (90+)  Pre-configured solution for Partezis, 22 hospitals in Belgium  Rapid growth in France (50+) and Spain  France: Deploying standard solution to 15 hospitals in AP-HP group in Paris – centrally hosted  Spain : bioMérieux distribute pre-configured microbiology solution  20 years history of successful deployment  200 pathology specialists  400+ LIMS installations in 10 countries  Scaleable solutions ranging from small private lab through to large, complex, multi-site pathology network  Multi-lingual solutions
  14. 14. www.mips.b e LIS Market Share in Mature Markets 60 50 %age share 40 30 20 10 0 Netherlands Belgium UK Ireland
  15. 15. www.mips.b e Specialised in large complex IT-solutions for clinical laboratories Connection with hospital information system Direct bidirectional connections with analyzers Drivers Remote result consultation Data Manager or Concentrators LIS Remote order entry Laboratory clients
  16. 16. www.mips.b e Drivers  More then 250 different analyzers are currently in use with Glims.  Over the years, in total 600 analyzers have been interfaced with Glims.  GLIMS is able to communicate with several hospital information systems simultaneously to support laboratories servicing several hospitals.  The standards supported include HL7, HL7-XML, HPRIM, LDT, ASTM, XML,CPAGE and Edifact
  17. 17. www.mips.b e Agenda MIPS Company Products MIPS product development process Defect prevention Defect correction Q&A
  18. 18. www.mips.b e MIPS product development process  Pro-active : Defect prevention  Development process includes  Safety risk management process  Guided by IVD MD FDA and ISO regulations  Multiple reviews  Re-active : Defect correction  Verification : Did we make it right ?  Validation : Did we make the right thing ?
  19. 19. www.mips.b e DP: Safety risk management process  An effective risk management program encourages a defect prevention mindset  Safety risk management can prevent safety related problems  Safety risk management provides a basis for defining different levels of test and review  Safety risk management encourages defensive design practices  Safety risk management reduces civil liability as well as satisfies regulatory requirements
  20. 20. www.mips.b e DP: Safety risk management process 1. Risk Formal analysis methods (FMEA and FTA) Analysis Regulatory standards compliance Historical analyses Evaluate severity 2. Risk Define safety requirement Evaluation Assign probability Evaluate residual risk Define controls and perform residual risk 3. Risk evaluation Control Review adequacy of safety 4. Post for changes and defects Production Information
  21. 21. www.mips.b e MIPS product development process  Pro-active : Defect prevention  Development process includes  Safety risk management process  Guided by IVD MD FDA and ISO regulations  Multiple reviews  Re-active : Defect correction  Verification : Did we make it right ?  Validation : Did we make the right thing ?
  22. 22. www.mips.b e Defect prevention: Multiple reviews SW modification life cycle Product coordinator Analyst Programmer Code reviewer Tester Documenter Unassigned Product coordinator Analyst Programmer Code reviewer Tester Documenter Unassigned Analysis Discontinued Analysis On hold review Code Code review Delta Test Documentation Final review Committed
  23. 23. www.mips.b e Agenda MIPS Company Products MIPS product development process Defect prevention Defect correction Q&A
  24. 24. www.mips.b e MIPS product development process  Pro-active : Defect prevention  Development process includes  Safety risk management process  Guided by IVD MD FDA and ISO regulations  Multiple reviews  Re-active : Defect correction  Verification : Did we make it right ?  Validation : Did we make the right thing ?
  25. 25. www.mips.b e DC: Verification and Validation process RoadMap Start Develpment Unit Testing Develop men t End D evelopment Ana lysis Alfa R elease Start Integration Testing Ga te way In teg ra tio n End Integration Tes ting Ne w Fe ature s Reg ressio n Beta Release Start Beta Testing Beta Test End Beta Testing Scenarios GA Release
  26. 26. www.mips.b e DC: Verification – unit testing process
  27. 27. www.mips.b e DC: Verification -integration testing process
  28. 28. www.mips.b e DC: Verification -integration testing process  Verification and Validation process :  How ? Structured Testing  Lifecycle of Structured Testing: LST (Tmap)  Planning & Control  Preparation P S E C  Specification  Execution  Completion P-C
  29. 29. www.mips.b e Test Planning & Control  MIA (MIPS Internal Application)  MS Project  Access (ODBC on MIA) Pivot Tables and Charts
  30. 30. www.mips.b e Test Preparation  MIA: Modification and Incidents Logs  SSD (Software Specification Document)
  31. 31. www.mips.b e Test Specification  Test Case Specification Document  Test Cases (if applicable)  Pre-condition  Test case  Expected result  Test Data (if applicable)  Test System Requirement (if applicable)
  32. 32. www.mips.b e Test Execution (1)  Test Case Specification document executed and logged in MIA (icl. attachments)  Traceability
  33. 33. www.mips.b e Test Execution (2)  Unit test fails: Solution “rejected” and send back to developer  Integration test fails: “Failure” documented and automatically generated incident
  34. 34. www.mips.b e Test Control  Test Progress Reporting  Formal Test Plan and Report (if applicable)
  35. 35. www.mips.b e MIPS product development process  Pro-active : Defect prevention  Development process includes  Safety risk management process  Guided by IVD MD FDA and ISO regulations  Multiple reviews  Re-active : Defect correction  Verification : Did we make it right ?  Validation : Did we make the right thing ?
  36. 36. www.mips.b Beta Test Scenarios End Beta Testing e DC: Validation process - Customer level GA Release
  37. 37. www.mips.b e Certification and audits  External audits:  ISO 9001 certified by ISOQAR  Scope: Development, deployment, sales and support  MIPS Gent and MIPS France  Astrazenica – bioMérieux  Internal audits  Procedure in place that defines who should do what in case of a major defect in the field  Customers  Corrective measures  Undo the mistake  Preventive measures  Work-around  Install new version
  38. 38. www.mips.b e Conclusions  By improving on a continuous basis it’s  People  Processes  Products MIPS tries to prevent any defects in his SW products  “You get what you inspect, not what you expect…”
  39. 39. www.mips.b e Q&A

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