software validation and testing - bmia.be · 2014. 11. 14. · software validation and testing...
TRANSCRIPT
![Page 1: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/1.jpg)
www.mips.be
Software Validation and Testing
Geert AckeQuality Manager MIPS (Clinisys)
22/04/2008
![Page 2: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/2.jpg)
www.mips.be
Agenda
MIPS CompanyProducts
MIPS product development processDefect preventionDefect correction
Q&A
![Page 3: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/3.jpg)
www.mips.be
We offer Solutions to improve the efficiency of clinical
laboratories
Based on
Standardized Software and Customized Services and Support to meet specific customer requirements
![Page 4: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/4.jpg)
www.mips.be
Group Operating structure
.
MIPS
Europe
CliniSys
UK & Ireland
![Page 5: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/5.jpg)
www.mips.be
Group Global Coverage – Local Delivery
200 DedicatedHealthcare IT Professionals
Over 850 Sites Using CliniSys’ Solutions
Supporting 100,000 Healthcare Professionals
![Page 6: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/6.jpg)
www.mips.be
Clinisys : Pan-European Group
Chertsey
Gent
Hamburg
Paris
Madrid
Glasgow
Chertsey
Gent
Hamburg
Paris
Madrid
Glasgow
Chertsey
Gent
Hamburg
Paris
Madrid
Glasgow
Chertsey
Gent
Hamburg
Paris
Madrid
Glasgow
Development Centre: Chertsey(Clinisys) Glasgow(Clinisys) Gent (MIPS)
Sales and Support Offices: Clinisys
Glasgow (Scotland) Chertsey (England)
MIPS Gent (Belgium) Hamburg (Germany) Paris (France) Madrid (Spain)
![Page 7: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/7.jpg)
www.mips.be
Agenda
MIPS CompanyProducts
MIPS product development processDefect preventionDefect correction
Q&A
![Page 8: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/8.jpg)
www.mips.be
MIPS products
Glims Glims Laboratory information system (LIS)
Samplenet Samplenet Data manager
CyberlabCyberlab Result consultation via Intranet /Internet and electronic order entry
Drivers Interface with IVD MD and HIS
ArchieArchie XML Archiving
![Page 9: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/9.jpg)
www.mips.be
Remote order entry
Remote result consultation
Laboratory clients
Data Manager or Concentrators
Connection with hospital information system Direct bidirectional connections
Specialised in large complex IT-solutions for clinical laboratries
LIS
![Page 10: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/10.jpg)
www.mips.be
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
![Page 11: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/11.jpg)
www.mips.be
Remote order entry
Remote result consultation
Laboratory clients
Data Manager or Concentrators
Connection with hospital information system Direct bidirectional connections
with analyzers
Specialised in large complex IT-solutions for clinical laboratories
LIS
Drivers
![Page 12: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/12.jpg)
www.mips.be
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
![Page 13: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/13.jpg)
www.mips.be
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
![Page 14: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/14.jpg)
www.mips.be
LIS Market Share in Mature Markets
0
10
20
30
40
50
60
Netherlands Belgium UK Ireland
%ag
e s
hare
![Page 15: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/15.jpg)
www.mips.be
Remote order entry
Remote result consultation
Laboratory clients
Data Manager or Concentrators
Connection with hospital information system Direct bidirectional connections
with analyzers
Specialised in large complex IT-solutions for clinical laboratories
LIS
Drivers
![Page 16: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/16.jpg)
www.mips.be
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
![Page 17: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/17.jpg)
www.mips.be
Agenda
MIPS CompanyProducts
MIPS product development processDefect preventionDefect correction
Q&A
![Page 18: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/18.jpg)
www.mips.be
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 ?
MIPS product development process
![Page 19: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/19.jpg)
www.mips.be
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
DP: Safety risk management process
![Page 20: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/20.jpg)
www.mips.be
1. Risk Analysis
2. Risk Evaluation
3. Risk Control
4. Post Production Information
Formal analysis methods (FMEA and FTA)Regulatory standards complianceHistorical analyses
Evaluate severityDefine safety requirementAssign probabilityEvaluate residual risk
Define controls and perform residual risk evaluation
Review adequacy of safetyfor changes and defects
DP: Safety risk management process
![Page 21: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/21.jpg)
www.mips.be
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 ?
MIPS product development process
![Page 22: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/22.jpg)
www.mips.be
SW modification life cycle
DocumenterDocumenterTesterTester UnassignedUnassignedCode reviewerCode reviewerProgrammerProgrammerAnalystAnalystProduct coordinatorProduct coordinator
Analysis
Analysis review
Code
Code review
Delta
Test
Final review
Documentation
Discontinued
Committed
On hold
Defect prevention: Multiple reviews
![Page 23: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/23.jpg)
www.mips.be
Agenda
MIPS CompanyProducts
MIPS product development processDefect preventionDefect correction
Q&A
![Page 24: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/24.jpg)
www.mips.be
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 ?
MIPS product development process
![Page 25: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/25.jpg)
www.mips.be
DC: Verification and Validation processRoadMap
Start Develpment
Start Integration Testing
End Development
End Integration Testing
Start Beta Testing
End Beta Testing
Beta Release
GA Release
Alfa Release
Unit Testing
Development
Analysis
Gateway
New Features
Integration
Regression
Beta Test Scenarios
![Page 26: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/26.jpg)
www.mips.be
DC: Verification – unit testing process
RoadMap
Start Develpment
Unit Testing
Development
Analysis
![Page 27: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/27.jpg)
www.mips.be
DC: Verification -integration testing process
Start Integration Testing
End Development
Alfa Release
Gateway
New Features
Integration
Regression
![Page 28: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/28.jpg)
www.mips.be
DC: Verification -integration testing process
Verification and Validation process : How ? Structured Testing
Lifecycle of Structured Testing: LST (Tmap)
Planning & Control Preparation Specification Execution Completion
P - C
CP S E
![Page 29: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/29.jpg)
www.mips.be
Test Planning & Control
MIA (MIPS Internal Application) MS Project Access (ODBC on MIA) Pivot Tables and Charts
![Page 30: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/30.jpg)
www.mips.be
Test Preparation
MIA: Modification and Incidents Logs SSD (Software Specification Document)
![Page 31: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/31.jpg)
www.mips.be
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)
![Page 32: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/32.jpg)
www.mips.be
Test Execution (1)
Test Case Specification document executed and logged in MIA (icl. attachments) Traceability
![Page 33: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/33.jpg)
www.mips.be
Test Execution (2) Unit test fails: Solution
“rejected” and send back to developer
Integration test fails: “Failure” documented and automatically generated incident
![Page 34: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/34.jpg)
www.mips.be
Test Control
Test Progress Reporting Formal Test Plan and Report (if applicable)
![Page 35: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/35.jpg)
www.mips.be
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 ?
MIPS product development process
![Page 36: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/36.jpg)
www.mips.be
DC: Validation process - Customer level
End Integration Testing
Start Beta Testing
End Beta Testing
Beta Release
GA Release
Beta Test Scenarios
![Page 37: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/37.jpg)
www.mips.be
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
![Page 38: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/38.jpg)
www.mips.be
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…”
![Page 39: Software Validation and Testing - BMIA.be · 2014. 11. 14. · Software Validation and Testing Geert Acke Quality Manager MIPS (Clinisys) 22/04/2008. e Agenda MIPS Company ... Verification](https://reader036.vdocuments.us/reader036/viewer/2022071023/5fd76991d055fd112c28af6f/html5/thumbnails/39.jpg)
www.mips.be
Q&A