CRO Audit & Monitoring Quality Perspectives.pdf
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This document discusses key components of quality management systems for clinical research. It defines quality as compliance or conformance to rules, regulations, guidance, specifications or requirements set by internal or external customers for products, processes or services. For clinical research specifically, quality means data, procedures, processes and activities adhere to expectations of honesty, integrity, accuracy and completeness. The document also distinguishes between quality control, which inspects and certifies quality through control systems, and quality assurance, which designs quality systems and assesses system performance through independent auditing.
CRO Audit & Monitoring Quality Perspectives.pdf
- 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