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Product Documentation Chapter 5. Title 21 of the Code of Federal Regulations  Volume 1: Parts 1-99 (FDA, General)  Volume 2: Parts 100-169 (FDA, Food.

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Presentation on theme: "Product Documentation Chapter 5. Title 21 of the Code of Federal Regulations  Volume 1: Parts 1-99 (FDA, General)  Volume 2: Parts 100-169 (FDA, Food."— Presentation transcript:

1 Product Documentation Chapter 5

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3 Title 21 of the Code of Federal Regulations  Volume 1: Parts 1-99 (FDA, General)  Volume 2: Parts (FDA, Food for Human Consumption)  Volume 3: Parts (FDA, Food for Human Consumption)  Volume 4: Parts (FDA, Drugs: General)  Volume 5: Parts (FDA, Drugs for Human Use)  Volume 6: Parts (FDA, Animal Drugs, Feeds and Related Products)  Volume 7: Parts (FDA, Biologics; Cosmetics)  Volume 8: Parts (FDA, Medical Devices)  Volume 9: Parts 1300-End (DEA and Office of National Drug Control Policy)

4 21CFR part 820 requires:  Business proposal  Product specification  Design specification  Software Quality Assurance Plan*  Software Requirements Specification*  Software Design Description*  * = if /where applicable

5 Primary types of records  Design History File (DHF)  Device Master Record (DMR)  Device History Record (DHR)  Technical Documentation File (TDF)

6 Business Proposal Business Proposal Project Overview Core Project Team Recommendation Supporting Documentation Economic Analysis Risk Analysis and Research Plan Strategic Fit Product Proposal Market Need and Potential

7 Project Overview, Objectives, Major Milestones, and Schedule  Statement of overall project objectives and major milestones  Objectives clearly define project scope and provide specific direction  Schedule anticipates key decision points and completion of primary deliverables  Events contingent upon achievements of estimated dates should be stated

8 Example Timeline (Gantt)

9 Market Need/ Potential  Defines customer and clinical need for product or service  Identifies potential territories to be served  Examine market size and trends  Compare product with competitors, …

10 Product Proposal  Proposes the product idea that fulfills the market need  Differentiates product features  Explains user and/or clinical value  Several alternatives product ideas should be evaluated against ‘base case’ idea

11 Strategic Fit  Discusses how the proposed product conforms with (or departs from) stated technology with respect to:  Product  Market  Clinical setting  Technology  Design  Manufacturing  Service Where do the pieces fit?

12 Risk Analysis and Research Plan  Assessment of risks and unknowns  Estimate of resources needed to reduce risks to a level with a reasonably high level of confidence  Risk categories:  Technical  Market  Financial  Regulatory  Available resources  Schedule

13 Economic Analysis  Rough estimate of costs and personnel required to specify, design, develop, and launch each product variant into the market place

14 Core Project Team  Formation of core project team to perform research to reduce risks, develop user specification, and prepare project plan  Outline requisite skills of proposed team members  Estimate approximate time required of each participant  Estimate incremental expenses

15 NCIIA Example follows:

16 Proposal Requirements Proposal Requirements  Project and feature descriptions  Project’s market potential  Social and environmental impact  Team members, skills, roles, resumes  All advisors  Work plan and timeline  Necessary equipment and resources  Budget in tabular format

17 Proposal Evaluation – Project Aspect Proposal Evaluation – Project Aspect  Technical feasibility.  Technology that is appropriate, achievable, and commercially sustainable.  A plan and budget are reasonable and achievable.  Likelihood of development of a licensable or marketable product or service.  Demonstrated knowledge of market and evidence of consumer interest.

18 Proposal Evaluation -Team Aspect Proposal Evaluation -Team Aspect  Appropriate student and advisor skills  Team membership: Balance of business, technical, and other specialists. External mentors. Diversity reflecting the institution’s population. Balance of business, technical, and other specialists. External mentors. Diversity reflecting the institution’s population.  Team (faculty, students, mentors, and institution) commitment.  Strong faculty recommendations.  Strong faculty recommendations.

19 Product Specification  First step in transforming product ideas into approved product development efforts  Subject to revision level control  Joint ownership among all concerned departments Product specification helps turn this into reality

20 Design Specification  Derived from product specification  Requirements are reduced to specific design requirements  Addresses each subsystem  Each performance specification should be listed with nominal worst case requirements

21 Software Quality Assurance Plan (SQAP)  Assures that procedures, tools and techniques used during software development and modification are adequate to provide desired level of confidence in final product  Assures that software does not reduce reliability of device  Detailed listing of requirements

22 Software Requirements Specification (SRS)  Specification for a particular software product or programs that perform certain functions  Correctly defines software requirements  Each software requirement is a statement of some essential capability of the software to be developed

23 Software Design Description (SDD)  Specifies necessary information content and recommended organization for a software design description  Detailed blueprint for implementation activity  Each requirement must be traceable to one or more design entities

24 Records Mandated:

25 Design History File (DHF)  Compilation of records which describes the design history of a finished device  Contains or references the records necessary to prove that the design was developed in accordance with approved design plans  Contains ‘institutional’ memory of previous design activities  Contains verification and validation protocols

26 Device Master Record  Design specifications  Production specifications  QA procedures  Packaging/labeling specifications  Install/maintenance/service methods

27 Device History Record  Date(s) of manufacture  Quantities manufactured  Quantities released  Acceptance records (DMR proof)  ID & labeling information  Device ID/control numbers  MDRs

28 Technical Documentation File (TDF)  Contains relevant design data which demonstrates that essential safety requirements are satisfied  File must be kept for 10 years after production stops in case of liability proceedings  Allows assessment of the conformity of the product with requirements of the Medical Device Directives

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