design history file dhf Sop

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                                   Design History File (DHF)

                                              A documented, comprehensive, systematic examination of a design
                                              to evaluate the adequacy of the design requirements, to evaluate the
  Design Review
                                              capability of the design to meet those requirements, and to identify

                                              A compilation of Records that describes the design history of a
  Design History File
                                              Finished Product.

                                              A representative group designated at the initiation of Design Control
  Design Review Committee                     consisting of all functions supporting the design, development, and
                                              manufacturing of a Product.

  Medical Device                              Medical device, components and finished medical device.

                                              A systematic use of available information to identify Hazards and to
  Risk Analysis
                                              estimate the Risk.

The Quality System Regulation (QSR) requires that the DHF shall contain or reference the records
necessary to demonstrate that the design was developed in accordance with the approved design
plan and the requirements of this part. This requirement will be met by maintaining plans that meet
the design control requirements. The plans and subsequent updates must be part of the DHF. The
results of the design verification, including identification of the design, method(s), the date, and the
individual(s) performing the verification, must be documented in the DHF. The DHF contains
documents such as the design plans and input requirements, preliminary input specs, validation
data and preliminary versions of key DMR documents. These are needed to show that plans were
created, followed and specifications were met.

7.1     General Maintenance of Design History File
      The DHF must be maintained for each medical devices project once the COMPANY decided to
      develop under Design Control or as required by 21 CFR Part 820, Quality System Regulation.
      Project Leader/ Head of Engineering maintains the DHF file while the during the whole design
      project including successful transfer where applicable and ensures confidentiality of the file and
      must enter the title of each document that is put into the DHF into the Design History File Table
      of Contents.
      All design documentation is stored and organized in a manner to facilitate full traceability and
      document retrieval and prevent the inadvertent loss of records.

7.2     Content of the DHF

      Document Type                                  Document ID                                 Version        Status        Page
          SOP                                  XX_WWW_ZZZ_YYYY                                     1.0       Approved          6/9

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