User Requirements Specification – Manufacturing Software Validation

A User Requirements Specification (URS) document may be created for all new or replacement computerized systems as defined in the Software Development Life Cycle document and may also provide the basis for the system design and Process Flow Diagrams.

The purpose of the URS is to define the company’s interpretation of the projected users’ solution to the overall problem set/anticipated needs and not on the system or method of implementing that functionality. It defines the required functionality from a user’s perspective, the processes to be supported, the hardware on which the software to be designed will operate, and the system environment it will operate in.

If the new or replacement system constitutes a major change of, or an extension to an existing system, the URS should also include a description of the current system.

The URS will contain all provisions required for compliance with company quality initiatives and government regulations. The URS should have the a general description of the modules, data inputs and integration required to fulfill the business requirements. According to the FDA’s guidance on medical device software validation, typical requirements may include the following:

  • All software system inputs;
  • All software system outputs;
  • All functions that the software system will perform;
  • All performance requirements that the software will meet, (e.g., data throughput, reliability, and timing);
  • The definition of all external and user interfaces, as well as any internal software-to-system
  • interfaces;
  • How users will interact with the system;
  • What constitutes an error and how errors should be handled;
  • Required response times;
  • The intended operating environment for the software, if this is a design constraint (e.g., hardware platform, operating system);
  • All ranges, limits, defaults, and specific values that the software will accept; and
  • All safety related requirements, specifications, features, or functions that will be implemented in software

InstantGMP™ MD was developed with user requirements in mind.  It is a web-based Part 11 compliant manufacturing execution system that streamlines the entire process of manufacturing medical devices including material management, specification control, inventory control, master device records, design history files and electronic batch records. It simplifies the documentation and approval procedures to reduce production times and to keep all your manufacturing documentation organized. It has quality assurance procedures built in to prevent errors and to maximize quality, and to assure GMP compliance to make it easy to manufacture products regulated by the FDA.

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