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CRO Audit & Monitoring
Quality Perspectives
Dr.Prashant Bodhe
prashant.bodhe@gmail.com
The Standard Components of QMS in Clinical Research
Reference - The Concept of Quality in Clinical; Research; Science and Engineering Ethics
(2006) 12, 147-156
Key to Success for all - 01
 Compliance is Organizational responsibility &
mandatory act
 Compliance is not a individual responsibility
Key to Success for all - 02
 Compliance is Organizational responsibility &
mandatory act
 Compliance is not a individual responsibility
 Integrity as a culture
 Document properly what you do
 Do not document what you do not do
 Do it Right for the First Time, at the Right Time, in
the Right Manner
Quality is defined as (General Definition)
 Compliance/ Conformance/ Adherence to
 Rules &/or Regulations &/or Guidance &/or
Specifications &/or Requirements &/or
Expectations
 about a Products &/or Process &/or Services
 set by Internal &/or External Customers
Quality Definition for Clinical Research - 01
 A measurable or assessable Compliance/
Conformance/ Adherence
 with Rules &/or Regulations &/or Guidance &/or
Specifications &/or Requirements &/or Expectations
 about Data, Product(s), Procedure(s), Work
Process(s), Allied Activities(s)
 set by Internal &/or External Customers
Quality Definition for Clinical Research - 02
 Honest & Integrity
 Attributable and traceable
 Legible
 Contemporaneous
 Original
 Accurate, Precise
 Complete
 Consistent
 Enduring
 Available
 Reproducible (as applicable)
Quality Control / Quality Assurance
 Quality Control / Operational Units
 Responsible for inspecting and certifying
predefined quality expected in a product or
process through Quality Control Systems
 Quality Assurance / Audit Group
 Design Quality System including QC
 Assesses the Performance, Accuracy,
Reliability And Integrity Of Quality Systems
through Independent Auditing Activities
Thank you!!
prashant.bodhe@gmail.com

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CRO Audit & Monitoring Quality Perspectives.pdf

  • 1. CRO Audit & Monitoring Quality Perspectives Dr.Prashant Bodhe prashant.bodhe@gmail.com
  • 2.
  • 3. The Standard Components of QMS in Clinical Research Reference - The Concept of Quality in Clinical; Research; Science and Engineering Ethics (2006) 12, 147-156
  • 4. Key to Success for all - 01  Compliance is Organizational responsibility & mandatory act  Compliance is not a individual responsibility
  • 5. Key to Success for all - 02  Compliance is Organizational responsibility & mandatory act  Compliance is not a individual responsibility  Integrity as a culture  Document properly what you do  Do not document what you do not do  Do it Right for the First Time, at the Right Time, in the Right Manner
  • 6. Quality is defined as (General Definition)  Compliance/ Conformance/ Adherence to  Rules &/or Regulations &/or Guidance &/or Specifications &/or Requirements &/or Expectations  about a Products &/or Process &/or Services  set by Internal &/or External Customers
  • 7. Quality Definition for Clinical Research - 01  A measurable or assessable Compliance/ Conformance/ Adherence  with Rules &/or Regulations &/or Guidance &/or Specifications &/or Requirements &/or Expectations  about Data, Product(s), Procedure(s), Work Process(s), Allied Activities(s)  set by Internal &/or External Customers
  • 8. Quality Definition for Clinical Research - 02  Honest & Integrity  Attributable and traceable  Legible  Contemporaneous  Original  Accurate, Precise  Complete  Consistent  Enduring  Available  Reproducible (as applicable)
  • 9. Quality Control / Quality Assurance  Quality Control / Operational Units  Responsible for inspecting and certifying predefined quality expected in a product or process through Quality Control Systems  Quality Assurance / Audit Group  Design Quality System including QC  Assesses the Performance, Accuracy, Reliability And Integrity Of Quality Systems through Independent Auditing Activities