DR/DQ: Design Review / Design Qualification

Also called EDR (Enhanced Design Review), this verification step ensures that all regulatory and business requirements are not only taken into account from the beginning of the project but also that they are correctly translated and implemented all along the design life cycle without forgetting the source code generation. It allows detecting defect as soon as possible and to correct them at minimum cost and to avoid planning and budget shifts. When performed on systems already in production, it allows assessing system regulatory compliance level and its associated documentation in order to define the right remediation action plan.

 Define review strategies which fit the specific project context (supplier maturity, good practices…).

 Know regulatory and standard requirements applicable to Design Review and How to determine mandatory Design Review file information in order to be in compliance with regulatory requirements from EMEA, FDA (GMP, GLP, GCP, QSR…), ISO (9001, 13485)...

 Know how to define and optimize required review efforts according to project and dispatch review activities between different parties. Know how Design Review and Risk Analysis are in relation.

 Be capable to define and implement Enhanced Design Review (EDR).

 Know the extent of necessary techniques to perform successfully Design Review of industrial systems.

 Know how to use Design Review outcome in the validation file.

1. Introduction

Definitions. Design Review Objectives. Life cycles and project types. How to act in an uncertainty which decreases? Design Review and GAMP. Verification versus Validation.

2. Regulations, Guides and Standards

Description of applicable regulations, guides and standards. Position and expectation of officials regarding Design Review.

3. Design Qualification Documentation

How to document a Design Qualification? Design and development input elements. Design and development output elements. Design and development verification. Design and development validation. Change Management during design and development. Should we generate protocols and/or use verification check-lists. Who participates? What should we document?

4. Design Qualification of User Requirement Specifications – URS

Presentation of methods, tools and techniques to review URS, which allow validating needs regarding objectives. Definitions: URS, Specifications, Requirements… URS and project life cycle. Methodology to elaborate and URS. How to make the objectives SMART?

5. Design Qualification of Functional Specifications

Presentation of methods, tools and techniques to review Functional Specifications, which allow validating functional choices. Verify requirements traceability.

6. Design Qualification of Technical Specifications and Design File

Presentation of methods, tools and techniques to review system design and technical specifications, which allow validating technical choices. Required Documentation. Log book.

7. Design Qualification of Programs and Software

Presentation of methods, tools and techniques to review programs and software. What is a Code Review? How to verify that good programming practices have been followed?

8. Design Qualification of Tests

Presentation of methods, tools and techniques to review tests. Different types of tests. Supplier tests versus User tests.

9. Relationship between Supplier Audit and Design Qualification

How to use Supplier Audit in Design Review scope? Supplier audit, prerequisite to Integrated Validation.

10. Relationship between Risk Analysis and Design Qualification
How to use Risk Analyses in the Design Review process. Reminder on Risk Management (ISO 14971 / ICH Q9).

PRACTICAL CASE STUDY

Several practical case studies are proposed all along the training session.
A Multiple Choices Questionnaire is proposed at the end of the training session in order to evaluate the acquired knowledge.