How much is it Validation of OpenSource Software

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How much is it? Validation of Open-Source. Software Using the example of R Ph.

How much is it? Validation of Open-Source. Software Using the example of R Ph. USE 2010 – 20. 10. 2010 Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H

Company • HMS Analytical Software is a specialist for Information Technology in the field

Company • HMS Analytical Software is a specialist for Information Technology in the field of Data Analysis and Business Intelligence Systems • Profile – 40 employees in Heidelberg, Germany – SAS Institute Silver Consulting Partner for 14 years – Doing data oriented software projects for more than 20 years • Technologies – Analytics and Data Management: SAS, JMP, R, Microsoft SQL Server – Application Development: Microsoft. NET, Java Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 2

Our IT Services for the Life Science Industry (SAS, JMP and R) Independent Consulting

Our IT Services for the Life Science Industry (SAS, JMP and R) Independent Consulting Programming Data Management Training and Individual Coaching • Application Development and Integration • Software Validation • • Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 3

What does Open Source mean? • no support hotline or customer service for urgent

What does Open Source mean? • no support hotline or customer service for urgent requests • often do not focus on user interfaces and lacks good documentation (not user friendly) • open source libraries focus on the developer issues, and not on those of the users • often no information is available about which module has been tested and how much of the code is covered Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 4

General CONS of Open Source Software • no support hotline or customer service for

General CONS of Open Source Software • no support hotline or customer service for urgent requests • often do not focus on user interfaces and lacks good documentation (not user friendly) • open source libraries focus on the developer issues, and not on those of the users • often no information is available about which module has been tested and how much of the code is covered Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 5

General PROS of Open Source Software • the source code is available to all

General PROS of Open Source Software • the source code is available to all and can be modified • many open source projects are free of charge • no need to start from scratch, but rather use existing open source libraries • the amount of widely spread developers increases the probability to identify bugs • generally, a community of developers are able to provide support • makes license management easier Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 6

What is R? • R is an environment for statistical computing and graphics •

What is R? • R is an environment for statistical computing and graphics • R is a scripted based software language • Open Source Software Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 7

Why Use R? Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 8

Why Use R? Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 8

R under the General Public Licence • R is available free of charge •

R under the General Public Licence • R is available free of charge • everybody is allowed to use the software for any purpose • copies of the source code can be made free of charge or for a fee • the source code is open to everybody and may be modified • it is allowed to distribute the modified code for a fee, but the source code must be open for the customer Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 9

Principles Aspects of Using R in a Validated Environment „We can not use R

Principles Aspects of Using R in a Validated Environment „We can not use R because it is not validated“ • Would you validate Microsoft Excel? • What should be validated? • The FDA does not allow the use of R? Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 10

Principles Aspects of Using R in a Validated Environment Mat Soukup’s (Acting Team Lead

Principles Aspects of Using R in a Validated Environment Mat Soukup’s (Acting Team Lead at the FDA) closing remarks from his talk “Using R: Perspectives of a FDA Statistical Reviewe. R” at the use. R-Conference 2007. Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 11

Provided IQ-Tests of R • Basic packages: includes functions for arithmetic operations, complex numbers,

Provided IQ-Tests of R • Basic packages: includes functions for arithmetic operations, complex numbers, R expressions, linear models, regular expressions etc. • Call for this test routine: test. Installed. Basic(scope = "both") Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 12

Provided IQ-Tests of R • Base packages: includes functions for dates, grid graphics, regression

Provided IQ-Tests of R • Base packages: includes functions for dates, grid graphics, regression splines, ANOVA, data set examples etc. • Call for this test routine: test. Installed. Package(“base") Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 13

Provided IQ-Tests of R • Recommended packages: includes functions for bootstrapping classification, cluster analysis,

Provided IQ-Tests of R • Recommended packages: includes functions for bootstrapping classification, cluster analysis, kernel smoothing survival analysis etc. • Call for this test routine: test. Installed. Package(“recommended") Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 14

IQ of R What is tested? Dr. Peter Bewerunge © 2009 HMS Analytical Software

IQ of R What is tested? Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 15

OQ of R Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 16

OQ of R Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 16

OQ of R Disadvantages of this test approach Dr. Peter Bewerunge © 2009 HMS

OQ of R Disadvantages of this test approach Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 17

OQ of R Evaluation of this test approach Dr. Peter Bewerunge © 2009 HMS

OQ of R Evaluation of this test approach Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 18

OQ of R What should be done? Dr. Peter Bewerunge © 2009 HMS Analytical

OQ of R What should be done? Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 19

Calling R from other Software Systems Dr. Peter Bewerunge © 2009 HMS Analytical Software

Calling R from other Software Systems Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 20

Calling R from other Software Systems R (D) COM Server Dr. Peter Bewerunge ©

Calling R from other Software Systems R (D) COM Server Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 21

Calling R from other Software Systems RWeb. Services Dr. Peter Bewerunge © 2009 HMS

Calling R from other Software Systems RWeb. Services Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 22

Calling R from other Software Systems Rserve Dr. Peter Bewerunge © 2009 HMS Analytical

Calling R from other Software Systems Rserve Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 23

Calling R from other Software Systems. NET WCF Services Dr. Peter Bewerunge © 2009

Calling R from other Software Systems. NET WCF Services Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 24

Conclusion Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 25

Conclusion Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 25

Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 26

Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 26

Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 27

Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 27

Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 28

Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 28

Thank you for your Attention Dr. Peter Bewerunge Software Engineer HMS Analytical Software Gmb.

Thank you for your Attention Dr. Peter Bewerunge Software Engineer HMS Analytical Software Gmb. H Rohrbacher Str. 26 • 69115 Heidelberg Telefon +49 6221 6051 -0 Peter. Bewerunge@analytical-software. de www. analytical-software. de Dr. Peter Bewerunge © 2009 HMS Analytical Software Gmb. H 29