CRO Audit & Monitoring - Quality Perspectives Quality Defined

1. CRO Audit & Monitoring
Quality Perspectives
Dr.Prashant Bodhe
prashant.bodhe@gmail.com

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

10. Thank you!!
prashant.bodhe@gmail.com