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Product Documentation

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Volume 3: Parts 170-199 (FDA, Food for Human Consumption) ... Product specification helps turn this into reality. Design Specification ... – PowerPoint PPT presentation

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Title: Product Documentation


1
Product Documentation
  • Chapter 5

2
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3
Title 21 of the Code of Federal Regulations
  • Volume 1 Parts 1-99 (FDA, General)
  • Volume 2 Parts 100-169 (FDA, Food for Human
    Consumption)
  • Volume 3 Parts 170-199 (FDA, Food for Human
    Consumption)
  • Volume 4 Parts 200-299 (FDA, Drugs General)
  • Volume 5 Parts 300-499 (FDA, Drugs for Human
    Use)
  • Volume 6 Parts 500-599 (FDA, Animal Drugs, Feeds
    and Related Products)
  • Volume 7 Parts 600-799 (FDA, Biologics
    Cosmetics)
  • Volume 8 Parts 800-1299 (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
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
  • Project and feature descriptions
  • Projects 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
  • 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
  • Appropriate student and advisor skills
  • Team membership
  • Balance of business, technical, and other
    specialists. External mentors. Diversity
    reflecting the institutions population.
  • Team (faculty, students, mentors, and
    institution) commitment.
  • 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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