PhUSE, CfConference 2010 - Lex Jansen · 2010-11-22 · PhUSE, CfConference 2010 Berlin, 17-20...
Transcript of PhUSE, CfConference 2010 - Lex Jansen · 2010-11-22 · PhUSE, CfConference 2010 Berlin, 17-20...
![Page 1: PhUSE, CfConference 2010 - Lex Jansen · 2010-11-22 · PhUSE, CfConference 2010 Berlin, 17-20 October 2010 Vendor Selection & Management in GxP critical IT projects Claus le Fevre,](https://reader033.fdocuments.in/reader033/viewer/2022042803/5f4f8cac78e9183178413b67/html5/thumbnails/1.jpg)
PhUSE C f 2010PhUSE, Conference 2010Berlin, 17-20 October 2010
Vendor Selection & Management in GxP critical IT projectsClaus le Fevre, Consulting Director, NNIT A/S
Author: xxxx • Approved by: xxxx • Version xx INTERNAL USE ONLYSlide 1
![Page 2: PhUSE, CfConference 2010 - Lex Jansen · 2010-11-22 · PhUSE, CfConference 2010 Berlin, 17-20 October 2010 Vendor Selection & Management in GxP critical IT projects Claus le Fevre,](https://reader033.fdocuments.in/reader033/viewer/2022042803/5f4f8cac78e9183178413b67/html5/thumbnails/2.jpg)
AgendaAgenda
Introduction1
Approach to vendor selection2
C l i4
Risk based validation 3
Conclusion4
Slide 2
![Page 3: PhUSE, CfConference 2010 - Lex Jansen · 2010-11-22 · PhUSE, CfConference 2010 Berlin, 17-20 October 2010 Vendor Selection & Management in GxP critical IT projects Claus le Fevre,](https://reader033.fdocuments.in/reader033/viewer/2022042803/5f4f8cac78e9183178413b67/html5/thumbnails/3.jpg)
The Right Quality Level…
YesCommon SenseNo YesCommon SenseNo
Bureaucracy Quality
YesBureaucracy Quality
Standards &
Chaos Creative Chaos
Methods
No
Slide 3
![Page 4: PhUSE, CfConference 2010 - Lex Jansen · 2010-11-22 · PhUSE, CfConference 2010 Berlin, 17-20 October 2010 Vendor Selection & Management in GxP critical IT projects Claus le Fevre,](https://reader033.fdocuments.in/reader033/viewer/2022042803/5f4f8cac78e9183178413b67/html5/thumbnails/4.jpg)
AgendaAgenda
Introduction1
Approach to vendor selection2
C l i4
Risk based validation 3
Conclusion4
Slide 4
![Page 5: PhUSE, CfConference 2010 - Lex Jansen · 2010-11-22 · PhUSE, CfConference 2010 Berlin, 17-20 October 2010 Vendor Selection & Management in GxP critical IT projects Claus le Fevre,](https://reader033.fdocuments.in/reader033/viewer/2022042803/5f4f8cac78e9183178413b67/html5/thumbnails/5.jpg)
Computer validation modelComputer validation model
El b ti /
gem
ent
InceptionElaboration/Construction Transition
n ort
Vendor
man
ag
Val
idat
ion p
la
Val
idat
ion r
ep
V
User requirements specification . Performance qualification
V V
.
.
.
Installation qualification
System specification - Functional part
Detailed specification
Coding
Operational qualification
Unit test
Code review
System specification - technical part
Time
g
Slide 5
![Page 6: PhUSE, CfConference 2010 - Lex Jansen · 2010-11-22 · PhUSE, CfConference 2010 Berlin, 17-20 October 2010 Vendor Selection & Management in GxP critical IT projects Claus le Fevre,](https://reader033.fdocuments.in/reader033/viewer/2022042803/5f4f8cac78e9183178413b67/html5/thumbnails/6.jpg)
Computer validation modelComputer validation model
El b ti /
gem
ent
InceptionElaboration/Construction Transition
n ort
Vendor
man
ag
Val
idat
ion p
la
Val
idat
ion r
ep
V
User requirements specification . Performance qualification
V V
.
.
.
Installation qualification
Time
Slide 6
![Page 7: PhUSE, CfConference 2010 - Lex Jansen · 2010-11-22 · PhUSE, CfConference 2010 Berlin, 17-20 October 2010 Vendor Selection & Management in GxP critical IT projects Claus le Fevre,](https://reader033.fdocuments.in/reader033/viewer/2022042803/5f4f8cac78e9183178413b67/html5/thumbnails/7.jpg)
Selection of vendor
Identification of potential vendorsBusiness application
Prior experience
Indication of capabilities
Potential vendors
Vendors chosen for proof-of-conceptFunctionality of application
Capabilities and competencies
Knowledge of business processes
Technical competencies
Proof-of-concept
Validation Management
Test Management
h l i f dSelection
The selection of vendor
The formal vendor audit
Slide 7
![Page 8: PhUSE, CfConference 2010 - Lex Jansen · 2010-11-22 · PhUSE, CfConference 2010 Berlin, 17-20 October 2010 Vendor Selection & Management in GxP critical IT projects Claus le Fevre,](https://reader033.fdocuments.in/reader033/viewer/2022042803/5f4f8cac78e9183178413b67/html5/thumbnails/8.jpg)
Proof-of-concept workshop – an example
Demonstration and discussion of general validation approachcontent of and interfaces between processes (workflows) used for validation activities (for example Computer system validation SOP, Test Management SOP and handling of non-conformities SOP)
Demonstration and discussion of validation deliverablescontent & walkthrough of package
the full portfolio of documents (e g plans protocols reports test cases & CILs)the full portfolio of documents (e.g. plans, protocols, reports, test cases & CILs)
Presentation and discussion of general development approachcontent of processes for development of user requirements, functional and technical p p q ,design requirements
how are design reviews and code reviews performed and documented
P t ti d di i f l t ti itiPresentation and discussion of release management activitiescontent of processes (workflows) used for releasing of upgrades and patches
Slide 8
![Page 9: PhUSE, CfConference 2010 - Lex Jansen · 2010-11-22 · PhUSE, CfConference 2010 Berlin, 17-20 October 2010 Vendor Selection & Management in GxP critical IT projects Claus le Fevre,](https://reader033.fdocuments.in/reader033/viewer/2022042803/5f4f8cac78e9183178413b67/html5/thumbnails/9.jpg)
Proof-of-concept workshop – an example
Demonstration of tool for automatic OQ test generation and test executiontest execution
structure and functionality of the tool
validation of the tool and relevant documentation
Presentation of activities to prepare and execute the automated OQ test cases
how are the OQ test cases (TCs) built and what guidelines are used
what kind of reviewing and approval activities are performed of the OQ TCs
Known challenges of using the tool in projects?Known challenges of using the tool in projects?
Slide 9
![Page 10: PhUSE, CfConference 2010 - Lex Jansen · 2010-11-22 · PhUSE, CfConference 2010 Berlin, 17-20 October 2010 Vendor Selection & Management in GxP critical IT projects Claus le Fevre,](https://reader033.fdocuments.in/reader033/viewer/2022042803/5f4f8cac78e9183178413b67/html5/thumbnails/10.jpg)
Value of the proof-of-concept?
Significant knowledge of vendor strengths and weaknessesWhat are the risksWhat are the risks
To what extent can we reuse vendor validation deliverables
Input to which quality assuring activities to implement
Vendor better able to understand our requirementsHow do we approach validation
Whi h i t d h di lid ti d li blWhich requirements do we have regarding validation deliverables
Increased openness between the parties
Strengthened personal business relationship
Input for special focus areas in the formal audit
Slide 10
![Page 11: PhUSE, CfConference 2010 - Lex Jansen · 2010-11-22 · PhUSE, CfConference 2010 Berlin, 17-20 October 2010 Vendor Selection & Management in GxP critical IT projects Claus le Fevre,](https://reader033.fdocuments.in/reader033/viewer/2022042803/5f4f8cac78e9183178413b67/html5/thumbnails/11.jpg)
How to select the vendorHow to select the vendor
Slide 11
![Page 12: PhUSE, CfConference 2010 - Lex Jansen · 2010-11-22 · PhUSE, CfConference 2010 Berlin, 17-20 October 2010 Vendor Selection & Management in GxP critical IT projects Claus le Fevre,](https://reader033.fdocuments.in/reader033/viewer/2022042803/5f4f8cac78e9183178413b67/html5/thumbnails/12.jpg)
The formal vendor auditThe formal vendor audit
Use knowledge from proof-of-concept activitiesUse knowledge from proof of concept activities
Focus on evidence of efficient QMSSelect carefully what to scrutinizeSelect carefully what to scrutinize
Focus on critical SW development and maintenance aspectsProject management & software development practicesj g p p
Release & configuration management
Can you still minimize your validation when upgrading to next releases
Accept terminology other than IQ, OQ, PQAs long as content complies with requirements
Use vendor documentation by referencing it in your own validation documents
Slide 12
Get behind the surface – talk to employees
![Page 13: PhUSE, CfConference 2010 - Lex Jansen · 2010-11-22 · PhUSE, CfConference 2010 Berlin, 17-20 October 2010 Vendor Selection & Management in GxP critical IT projects Claus le Fevre,](https://reader033.fdocuments.in/reader033/viewer/2022042803/5f4f8cac78e9183178413b67/html5/thumbnails/13.jpg)
AgendaAgenda
Introduction1
Approach to vendor selection2
C l i4
Risk based validation 3
Conclusion4
Slide 13
![Page 14: PhUSE, CfConference 2010 - Lex Jansen · 2010-11-22 · PhUSE, CfConference 2010 Berlin, 17-20 October 2010 Vendor Selection & Management in GxP critical IT projects Claus le Fevre,](https://reader033.fdocuments.in/reader033/viewer/2022042803/5f4f8cac78e9183178413b67/html5/thumbnails/14.jpg)
Risk based validationRisk based validation
Ri k b d hRisk based approachRisk based approach starts identifying risks associated with selected vendor
Risk based approach includes identifying impact on pp y g paspects of regulatory concern
Base risk analysis on GAMP 5 categoriesDifferent levels of risk analysis dependent on GAMP Different levels of risk analysis dependent on GAMP category
Different levels of GxP criticality in same system
Different levels of risk analysis during the Different levels of risk analysis during the project phases
Initial phase: Identify GxP modules and function
Design phase: Identify GxP critical record and control
Test phase: Identify different levels of testing
Slide 14
![Page 15: PhUSE, CfConference 2010 - Lex Jansen · 2010-11-22 · PhUSE, CfConference 2010 Berlin, 17-20 October 2010 Vendor Selection & Management in GxP critical IT projects Claus le Fevre,](https://reader033.fdocuments.in/reader033/viewer/2022042803/5f4f8cac78e9183178413b67/html5/thumbnails/15.jpg)
QA activities for vendor deliverables (GAMP cat. 5) l– an example
Vendor deliverablesVendor deliverablesSoftware modules
IQ, OQ, PQ test cases
Traceability matrix (to FRS)
Design walk-through-meetingl lk h h h d d d hFormal walk-through meeting where vendor presents design and test approach
Conclusion whether design can start
Defect walk-through meetingDefect walk through meetingReview of vendor deliverables
Evaluation of fulfilment of acceptance criteria
Input for formal design review
Reuse of test cases in validation
Slide 15
![Page 16: PhUSE, CfConference 2010 - Lex Jansen · 2010-11-22 · PhUSE, CfConference 2010 Berlin, 17-20 October 2010 Vendor Selection & Management in GxP critical IT projects Claus le Fevre,](https://reader033.fdocuments.in/reader033/viewer/2022042803/5f4f8cac78e9183178413b67/html5/thumbnails/16.jpg)
AgendaAgenda
Introduction1
Approach to vendor selection2
C l i4
Risk based validation 3
Conclusion4
Slide 16
![Page 17: PhUSE, CfConference 2010 - Lex Jansen · 2010-11-22 · PhUSE, CfConference 2010 Berlin, 17-20 October 2010 Vendor Selection & Management in GxP critical IT projects Claus le Fevre,](https://reader033.fdocuments.in/reader033/viewer/2022042803/5f4f8cac78e9183178413b67/html5/thumbnails/17.jpg)
ConclusionConclusionEvaluate the vendor capability
Screening
Establish knowledge of vendor strength and weaknesses
Face-to-face interaction
Structured selection of the vendor
Formal auditFocus especially on areas for special scrutiny
Risk based approach Which parts will the vendor be involved in?
Which QA activities will we implement to be able to benefit from vendor capabilities?
Slide 17
![Page 18: PhUSE, CfConference 2010 - Lex Jansen · 2010-11-22 · PhUSE, CfConference 2010 Berlin, 17-20 October 2010 Vendor Selection & Management in GxP critical IT projects Claus le Fevre,](https://reader033.fdocuments.in/reader033/viewer/2022042803/5f4f8cac78e9183178413b67/html5/thumbnails/18.jpg)
Thank you!Thank you!
Slide 18
![Page 19: PhUSE, CfConference 2010 - Lex Jansen · 2010-11-22 · PhUSE, CfConference 2010 Berlin, 17-20 October 2010 Vendor Selection & Management in GxP critical IT projects Claus le Fevre,](https://reader033.fdocuments.in/reader033/viewer/2022042803/5f4f8cac78e9183178413b67/html5/thumbnails/19.jpg)
Contact dataContact data
Consulting DirectorLife Sciences Consulting
Claus le Fevre
Life Sciences Consulting
NNIT A/SBuddingevej 197DK-2860 Søborg
+45 3075 3003 (mobile)+45 3075 3003 (mobile)
Slide 19