Detailed Design Specification – Manufacturing Software Validation

The Detailed Design Specification (DDS) describes how the hardware and software functionality identified in the Functional Specification will be developed and implemented.

The Hardware DDS is a description of the hardware on which the software resides and how it is to be connected to any existing system or equipment. Where possible, hardware used should be industry standard components from reputable suppliers with acceptable quality records, documentation standards, and maintenance procedures. The Hardware DDS reflects the requirements of all applications intended to run on this system.

The software section of the DDS is a description of the software components and sub-systems to be provided as part of the final application. The Software DDS contains all information required to build the system based on the functional specification. It should contain the entity relationship diagram of the database*; the inputs, which may include actual screens from the prototype; the processes, Process Flow Diagrams including any formulas and interfaces between modules; and outputs, including report layouts.

InstantGMP™ MD is a database-intensive, web-based application that allows for documenting the materials, process methods and environments for producing products regulated under Good Manufacturing Practices by the FDA. The priorities for the detailed design specifications are:

  • QSR (Quality System Regulation) compliance
  • cGMP compliance
  • 21 CFR Part 11 compliance
  • GAMP5 Standard compliance
  • User interface with consistency
  • Human-readable audit trail
  • Web based application running with Microsoft SQL in the backend

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