SlideShare uma empresa Scribd logo

Validation practical definition

•Transferir como PPTX, PDF•
•
Johan Hoberg
Johan Hoberg
1 de 1
Validation: A Practical Definition Risk Management Validation Guidelines Quality Criteria Verification Results Model Product Risks Analysis of Validation Test Analysis of Verification Activity Validation Results Results Test Gap Validation Quality Report Report Report Customer Requirements Regulatory Requirements

Recomendados

Qc Vs Qa
Qc Vs QaQc Vs Qa
Qc Vs Qaguestc990b6
 
General Validation Presentation
General Validation PresentationGeneral Validation Presentation
General Validation Presentationmarkaodonnell
 
Process validation
Process validationProcess validation
Process validationShreekantVader1
 
Vendor selection methods
Vendor selection methodsVendor selection methods
Vendor selection methodsHpm India
 
8.3 Control of Nonconforming Material
8.3 Control of Nonconforming Material8.3 Control of Nonconforming Material
8.3 Control of Nonconforming MaterialBrian McAuliffe
 
PHARMACEUTICAL VAILIDATION
PHARMACEUTICAL VAILIDATIONPHARMACEUTICAL VAILIDATION
PHARMACEUTICAL VAILIDATIONSayali Powar
 
Validation ppt nikita
Validation ppt nikitaValidation ppt nikita
Validation ppt nikitaNikitaNikam8
 
Processs validation
Processs validationProcesss validation
Processs validationavinashmane
 

Recomendados

Qc Vs Qa
Qc Vs QaQc Vs Qa
Qc Vs Qaguestc990b6
 
General Validation Presentation
General Validation PresentationGeneral Validation Presentation
General Validation Presentationmarkaodonnell
 
Process validation
Process validationProcess validation
Process validationShreekantVader1
 
Vendor selection methods
Vendor selection methodsVendor selection methods
Vendor selection methodsHpm India
 
8.3 Control of Nonconforming Material
8.3 Control of Nonconforming Material8.3 Control of Nonconforming Material
8.3 Control of Nonconforming MaterialBrian McAuliffe
 
PHARMACEUTICAL VAILIDATION
PHARMACEUTICAL VAILIDATIONPHARMACEUTICAL VAILIDATION
PHARMACEUTICAL VAILIDATIONSayali Powar
 
Validation ppt nikita
Validation ppt nikitaValidation ppt nikita
Validation ppt nikitaNikitaNikam8
 
Processs validation
Processs validationProcesss validation
Processs validationavinashmane
 
Quality concepts
Quality conceptsQuality concepts
Quality conceptsArvind sahu
 
Implementation Tracking – Project Part II
Implementation Tracking – Project Part IIImplementation Tracking – Project Part II
Implementation Tracking – Project Part IIDennis J Morgan
 
Quality management for civil engineering
Quality management for civil engineeringQuality management for civil engineering
Quality management for civil engineeringJayanta Sen
 
Validation ksd
Validation ksdValidation ksd
Validation ksdDr. Bakht Amin (Pharmacy Council Reg.No 5414)
 
Validation of pharmaceutical processes
Validation of pharmaceutical processesValidation of pharmaceutical processes
Validation of pharmaceutical processesonkarmarkunde1
 
Embedding quality assurance within procurement
Embedding quality assurance within procurementEmbedding quality assurance within procurement
Embedding quality assurance within procurementMyron Duncan Burton Betshanger
 
Pharmaceutical process validation.pptx
Pharmaceutical process validation.pptxPharmaceutical process validation.pptx
Pharmaceutical process validation.pptxPharmacy
 
Overview Section 1,2,3
Overview Section 1,2,3Overview Section 1,2,3
Overview Section 1,2,3alspread
 
Presentation ( testing )
Presentation ( testing )Presentation ( testing )
Presentation ( testing )ledadico
 
Testing
TestingTesting
Testinglilipabe
 
Cairo 02 Supplier Control
Cairo 02 Supplier ControlCairo 02 Supplier Control
Cairo 02 Supplier Controlahmad bassiouny
 
Bioprocess Validation
Bioprocess Validation Bioprocess Validation
Bioprocess Validation Pramod Pal
 
Validation of dosages form
Validation of dosages formValidation of dosages form
Validation of dosages formAkashYadav283
 
Procurement quality-management PJM400 Mod2
Procurement quality-management PJM400 Mod2Procurement quality-management PJM400 Mod2
Procurement quality-management PJM400 Mod2KHogan62
 
Quality Audit
Quality AuditQuality Audit
Quality AuditHafsa Munir
 
Validation vs. verification
Validation vs. verificationValidation vs. verification
Validation vs. verificationSaad Al Jabri
 
Validation of pharmaceutical dosage form
Validation of pharmaceutical dosage formValidation of pharmaceutical dosage form
Validation of pharmaceutical dosage formanurag chanda
 
V & V
V & VV & V
V & Vnirola
 
Validation m pharmacy notes scop satara
Validation m pharmacy notes scop sataraValidation m pharmacy notes scop satara
Validation m pharmacy notes scop sataranikhil salunkhe
 
Vendor qualification
Vendor qualificationVendor qualification
Vendor qualificationShihabPatel
 
Introdution of qa qc
Introdution of qa qcIntrodution of qa qc
Introdution of qa qcMohammed Ayoub Nizamani
 
Value Reference Model - Quality and Customer Care
Value Reference Model - Quality and Customer CareValue Reference Model - Quality and Customer Care
Value Reference Model - Quality and Customer CareArnaldo Colombo
 

Mais conteúdo relacionado

Mais procurados

Quality concepts
Quality conceptsQuality concepts
Quality conceptsArvind sahu
 
Implementation Tracking – Project Part II
Implementation Tracking – Project Part IIImplementation Tracking – Project Part II
Implementation Tracking – Project Part IIDennis J Morgan
 
Quality management for civil engineering
Quality management for civil engineeringQuality management for civil engineering
Quality management for civil engineeringJayanta Sen
 
Validation of pharmaceutical processes
Validation of pharmaceutical processesValidation of pharmaceutical processes
Validation of pharmaceutical processesonkarmarkunde1
 
Pharmaceutical process validation.pptx
Pharmaceutical process validation.pptxPharmaceutical process validation.pptx
Pharmaceutical process validation.pptxPharmacy
 
Overview Section 1,2,3
Overview Section 1,2,3Overview Section 1,2,3
Overview Section 1,2,3alspread
 
Presentation ( testing )
Presentation ( testing )Presentation ( testing )
Presentation ( testing )ledadico
 
Cairo 02 Supplier Control
Cairo 02 Supplier ControlCairo 02 Supplier Control
Cairo 02 Supplier Controlahmad bassiouny
 
Bioprocess Validation
Bioprocess Validation Bioprocess Validation
Bioprocess Validation Pramod Pal
 
Validation of dosages form
Validation of dosages formValidation of dosages form
Validation of dosages formAkashYadav283
 
Procurement quality-management PJM400 Mod2
Procurement quality-management PJM400 Mod2Procurement quality-management PJM400 Mod2
Procurement quality-management PJM400 Mod2KHogan62
 
Validation vs. verification
Validation vs. verificationValidation vs. verification
Validation vs. verificationSaad Al Jabri
 
Validation of pharmaceutical dosage form
Validation of pharmaceutical dosage formValidation of pharmaceutical dosage form
Validation of pharmaceutical dosage formanurag chanda
 
Validation m pharmacy notes scop satara
Validation m pharmacy notes scop sataraValidation m pharmacy notes scop satara
Validation m pharmacy notes scop sataranikhil salunkhe
 
Vendor qualification
Vendor qualificationVendor qualification
Vendor qualificationShihabPatel
 

Mais procurados (20)

Quality concepts
Quality conceptsQuality concepts
Quality concepts
 
Implementation Tracking – Project Part II
Implementation Tracking – Project Part IIImplementation Tracking – Project Part II
Implementation Tracking – Project Part II
 
Quality management for civil engineering
Quality management for civil engineeringQuality management for civil engineering
Quality management for civil engineering
 
Validation ksd
Validation ksdValidation ksd
Validation ksd
 
Validation of pharmaceutical processes
Validation of pharmaceutical processesValidation of pharmaceutical processes
Validation of pharmaceutical processes
 
Embedding quality assurance within procurement
Embedding quality assurance within procurementEmbedding quality assurance within procurement
Embedding quality assurance within procurement
 
Pharmaceutical process validation.pptx
Pharmaceutical process validation.pptxPharmaceutical process validation.pptx
Pharmaceutical process validation.pptx
 
Overview Section 1,2,3
Overview Section 1,2,3Overview Section 1,2,3
Overview Section 1,2,3
 
Presentation ( testing )
Presentation ( testing )Presentation ( testing )
Presentation ( testing )
 
Testing
TestingTesting
Testing
 
Cairo 02 Supplier Control
Cairo 02 Supplier ControlCairo 02 Supplier Control
Cairo 02 Supplier Control
 
Bioprocess Validation
Bioprocess Validation Bioprocess Validation
Bioprocess Validation
 
Validation of dosages form
Validation of dosages formValidation of dosages form
Validation of dosages form
 
Procurement quality-management PJM400 Mod2
Procurement quality-management PJM400 Mod2Procurement quality-management PJM400 Mod2
Procurement quality-management PJM400 Mod2
 
Quality Audit
Quality AuditQuality Audit
Quality Audit
 
Validation vs. verification
Validation vs. verificationValidation vs. verification
Validation vs. verification
 
Validation of pharmaceutical dosage form
Validation of pharmaceutical dosage formValidation of pharmaceutical dosage form
Validation of pharmaceutical dosage form
 
V & V
V & VV & V
V & V
 
Validation m pharmacy notes scop satara
Validation m pharmacy notes scop sataraValidation m pharmacy notes scop satara
Validation m pharmacy notes scop satara
 
Vendor qualification
Vendor qualificationVendor qualification
Vendor qualification
 

Semelhante a Validation practical definition

Value Reference Model - Quality and Customer Care
Value Reference Model - Quality and Customer CareValue Reference Model - Quality and Customer Care
Value Reference Model - Quality and Customer CareArnaldo Colombo
 
V-Empower Technical Competence Workflow
V-Empower Technical Competence WorkflowV-Empower Technical Competence Workflow
V-Empower Technical Competence WorkflowHannan Ahmed
 
TLMC Corporate Presentation-v 1.2
TLMC Corporate Presentation-v 1.2TLMC Corporate Presentation-v 1.2
TLMC Corporate Presentation-v 1.2Anil Balan
 
Test designandmanagementfreenest1dot4
Test designandmanagementfreenest1dot4Test designandmanagementfreenest1dot4
Test designandmanagementfreenest1dot4JAMK
 
CA Quality Management System
CA Quality Management SystemCA Quality Management System
CA Quality Management SystemWahyu Prasetianto
 
Requirements Engineering Pmi
Requirements Engineering PmiRequirements Engineering Pmi
Requirements Engineering PmiArta Doci
 
1. STUDY ON QUALITY ASSURANCE AND QUALITY CONTROL MANAGEMENT SYSTEM IN 20 STO...
1. STUDY ON QUALITY ASSURANCE AND QUALITY CONTROL MANAGEMENT SYSTEM IN 20 STO...1. STUDY ON QUALITY ASSURANCE AND QUALITY CONTROL MANAGEMENT SYSTEM IN 20 STO...
1. STUDY ON QUALITY ASSURANCE AND QUALITY CONTROL MANAGEMENT SYSTEM IN 20 STO...AELC
 
Obligations Of A Testbody And An Analytical Laboratory
Obligations Of A Testbody And An Analytical LaboratoryObligations Of A Testbody And An Analytical Laboratory
Obligations Of A Testbody And An Analytical LaboratoryChristianGroen
 
Tugas qc vs qa fredy & andreas
Tugas qc vs qa fredy & andreasTugas qc vs qa fredy & andreas
Tugas qc vs qa fredy & andreasfredyrantetaruk
 
Quality - Insurance Company Case Study
Quality - Insurance Company Case StudyQuality - Insurance Company Case Study
Quality - Insurance Company Case StudyJorge Rosas
 
Integrated methodology for testing and quality management.
Integrated methodology for testing and quality management.Integrated methodology for testing and quality management.
Integrated methodology for testing and quality management.Mindtree Ltd.
 
Quality assurance and control quality - PMP/CAPM by PMI
Quality assurance and control quality - PMP/CAPM by PMIQuality assurance and control quality - PMP/CAPM by PMI
Quality assurance and control quality - PMP/CAPM by PMIMudassir Iqbal
 
St Final Hsiq Questcon Sales Presentation 092006
St Final Hsiq Questcon Sales Presentation 092006St Final Hsiq Questcon Sales Presentation 092006
St Final Hsiq Questcon Sales Presentation 092006anjuabel
 
Tqm basic concepts-of_quality_comp_mode
Tqm basic concepts-of_quality_comp_modeTqm basic concepts-of_quality_comp_mode
Tqm basic concepts-of_quality_comp_modejamshidnikzad7
 

Semelhante a Validation practical definition (20)

Introdution of qa qc
Introdution of qa qcIntrodution of qa qc
Introdution of qa qc
 
Value Reference Model - Quality and Customer Care
Value Reference Model - Quality and Customer CareValue Reference Model - Quality and Customer Care
Value Reference Model - Quality and Customer Care
 
V-Empower Technical Competence Workflow
V-Empower Technical Competence WorkflowV-Empower Technical Competence Workflow
V-Empower Technical Competence Workflow
 
TAO DAYS - Process (IT session)
TAO DAYS - Process (IT session)TAO DAYS - Process (IT session)
TAO DAYS - Process (IT session)
 
Testing & Quality Assurance
Testing & Quality AssuranceTesting & Quality Assurance
Testing & Quality Assurance
 
TLMC Corporate Presentation-v 1.2
TLMC Corporate Presentation-v 1.2TLMC Corporate Presentation-v 1.2
TLMC Corporate Presentation-v 1.2
 
Test designandmanagementfreenest1dot4
Test designandmanagementfreenest1dot4Test designandmanagementfreenest1dot4
Test designandmanagementfreenest1dot4
 
CA Quality Management System
CA Quality Management SystemCA Quality Management System
CA Quality Management System
 
Requirements Engineering Pmi
Requirements Engineering PmiRequirements Engineering Pmi
Requirements Engineering Pmi
 
TAO DAYS - Process (User session)
TAO DAYS - Process (User session)TAO DAYS - Process (User session)
TAO DAYS - Process (User session)
 
1. STUDY ON QUALITY ASSURANCE AND QUALITY CONTROL MANAGEMENT SYSTEM IN 20 STO...
1. STUDY ON QUALITY ASSURANCE AND QUALITY CONTROL MANAGEMENT SYSTEM IN 20 STO...1. STUDY ON QUALITY ASSURANCE AND QUALITY CONTROL MANAGEMENT SYSTEM IN 20 STO...
1. STUDY ON QUALITY ASSURANCE AND QUALITY CONTROL MANAGEMENT SYSTEM IN 20 STO...
 
Obligations Of A Testbody And An Analytical Laboratory
Obligations Of A Testbody And An Analytical LaboratoryObligations Of A Testbody And An Analytical Laboratory
Obligations Of A Testbody And An Analytical Laboratory
 
57086 15 quality
57086 15 quality57086 15 quality
57086 15 quality
 
Quality Assurance & Control
Quality Assurance & ControlQuality Assurance & Control
Quality Assurance & Control
 
Tugas qc vs qa fredy & andreas
Tugas qc vs qa fredy & andreasTugas qc vs qa fredy & andreas
Tugas qc vs qa fredy & andreas
 
Quality - Insurance Company Case Study
Quality - Insurance Company Case StudyQuality - Insurance Company Case Study
Quality - Insurance Company Case Study
 
Integrated methodology for testing and quality management.
Integrated methodology for testing and quality management.Integrated methodology for testing and quality management.
Integrated methodology for testing and quality management.
 
Quality assurance and control quality - PMP/CAPM by PMI
Quality assurance and control quality - PMP/CAPM by PMIQuality assurance and control quality - PMP/CAPM by PMI
Quality assurance and control quality - PMP/CAPM by PMI
 
St Final Hsiq Questcon Sales Presentation 092006
St Final Hsiq Questcon Sales Presentation 092006St Final Hsiq Questcon Sales Presentation 092006
St Final Hsiq Questcon Sales Presentation 092006
 
Tqm basic concepts-of_quality_comp_mode
Tqm basic concepts-of_quality_comp_modeTqm basic concepts-of_quality_comp_mode
Tqm basic concepts-of_quality_comp_mode
 

Mais de Johan Hoberg

Approaches to unraveling a complex test problem
Approaches to unraveling a complex test problemApproaches to unraveling a complex test problem
Approaches to unraveling a complex test problemJohan Hoberg
 
A business case for a modern QA organization
A business case for a modern QA organizationA business case for a modern QA organization
A business case for a modern QA organizationJohan Hoberg
 
Signing off on Quality
Signing off on QualitySigning off on Quality
Signing off on QualityJohan Hoberg
 
Quality Information Coverage - A QI Concept
Quality Information Coverage - A QI ConceptQuality Information Coverage - A QI Concept
Quality Information Coverage - A QI ConceptJohan Hoberg
 
The Bug Backlog - An Evergrowing Mountain
The Bug Backlog - An Evergrowing MountainThe Bug Backlog - An Evergrowing Mountain
The Bug Backlog - An Evergrowing MountainJohan Hoberg
 
Quality Intelligence: Transparency & Visibility
Quality Intelligence: Transparency & VisibilityQuality Intelligence: Transparency & Visibility
Quality Intelligence: Transparency & VisibilityJohan Hoberg
 
Building a QA Mindset
Building a QA Mindset Building a QA Mindset
Building a QA Mindset Johan Hoberg
 
Building High Quality Software
Building High Quality Software Building High Quality Software
Building High Quality Software Johan Hoberg
 
Testit 2017 - Exploratory Testing for Everyone
Testit 2017 - Exploratory Testing for EveryoneTestit 2017 - Exploratory Testing for Everyone
Testit 2017 - Exploratory Testing for EveryoneJohan Hoberg
 
Don’t celebrate failure. Don’t celebrate success. Celebrate commitment, owner...
Don’t celebrate failure. Don’t celebrate success. Celebrate commitment, owner...Don’t celebrate failure. Don’t celebrate success. Celebrate commitment, owner...
Don’t celebrate failure. Don’t celebrate success. Celebrate commitment, owner...Johan Hoberg
 
Moving from scripted regression testing to exploratory testing
Moving from scripted regression testing to exploratory testingMoving from scripted regression testing to exploratory testing
Moving from scripted regression testing to exploratory testingJohan Hoberg
 
Building High Quality Software
Building High Quality SoftwareBuilding High Quality Software
Building High Quality SoftwareJohan Hoberg
 
Quality, Testing & Agile Methodologies
Quality, Testing & Agile MethodologiesQuality, Testing & Agile Methodologies
Quality, Testing & Agile MethodologiesJohan Hoberg
 
Defining Test Competence
Defining Test CompetenceDefining Test Competence
Defining Test CompetenceJohan Hoberg
 
Why all deadlines are bad for quality
Why all deadlines are bad for qualityWhy all deadlines are bad for quality
Why all deadlines are bad for qualityJohan Hoberg
 
Do we really need game testers?
Do we really need game testers?Do we really need game testers?
Do we really need game testers?Johan Hoberg
 
Hardware/Software Integration Testing
Hardware/Software Integration TestingHardware/Software Integration Testing
Hardware/Software Integration TestingJohan Hoberg
 

Mais de Johan Hoberg (20)

Approaches to unraveling a complex test problem
Approaches to unraveling a complex test problemApproaches to unraveling a complex test problem
Approaches to unraveling a complex test problem
 
A business case for a modern QA organization
A business case for a modern QA organizationA business case for a modern QA organization
A business case for a modern QA organization
 
Signing off on Quality
Signing off on QualitySigning off on Quality
Signing off on Quality
 
Quality Information Coverage - A QI Concept
Quality Information Coverage - A QI ConceptQuality Information Coverage - A QI Concept
Quality Information Coverage - A QI Concept
 
The Bug Backlog - An Evergrowing Mountain
The Bug Backlog - An Evergrowing MountainThe Bug Backlog - An Evergrowing Mountain
The Bug Backlog - An Evergrowing Mountain
 
Quality Intelligence: Transparency & Visibility
Quality Intelligence: Transparency & VisibilityQuality Intelligence: Transparency & Visibility
Quality Intelligence: Transparency & Visibility
 
Building a QA Mindset
Building a QA Mindset Building a QA Mindset
Building a QA Mindset
 
What is QI?
What is QI?What is QI?
What is QI?
 
Building High Quality Software
Building High Quality Software Building High Quality Software
Building High Quality Software
 
Testit 2017 - Exploratory Testing for Everyone
Testit 2017 - Exploratory Testing for EveryoneTestit 2017 - Exploratory Testing for Everyone
Testit 2017 - Exploratory Testing for Everyone
 
Don’t celebrate failure. Don’t celebrate success. Celebrate commitment, owner...
Don’t celebrate failure. Don’t celebrate success. Celebrate commitment, owner...Don’t celebrate failure. Don’t celebrate success. Celebrate commitment, owner...
Don’t celebrate failure. Don’t celebrate success. Celebrate commitment, owner...
 
Moving from scripted regression testing to exploratory testing
Moving from scripted regression testing to exploratory testingMoving from scripted regression testing to exploratory testing
Moving from scripted regression testing to exploratory testing
 
Building High Quality Software
Building High Quality SoftwareBuilding High Quality Software
Building High Quality Software
 
Quality, Testing & Agile Methodologies
Quality, Testing & Agile MethodologiesQuality, Testing & Agile Methodologies
Quality, Testing & Agile Methodologies
 
QI, not QA
QI, not QAQI, not QA
QI, not QA
 
Defining Test Competence
Defining Test CompetenceDefining Test Competence
Defining Test Competence
 
Why all deadlines are bad for quality
Why all deadlines are bad for qualityWhy all deadlines are bad for quality
Why all deadlines are bad for quality
 
QI, not QA
QI, not QAQI, not QA
QI, not QA
 
Do we really need game testers?
Do we really need game testers?Do we really need game testers?
Do we really need game testers?
 
Hardware/Software Integration Testing
Hardware/Software Integration TestingHardware/Software Integration Testing
Hardware/Software Integration Testing
 

Validation practical definition

  • 1. Validation: A Practical Definition Risk Management Validation Guidelines Quality Criteria Verification Results Model Product Risks Analysis of Validation Test Analysis of Verification Activity Validation Results Results Test Gap Validation Quality Report Report Report Customer Requirements Regulatory Requirements