What is your Software Development Life Cycle Process?

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What is your Software Development Life Cycle Process?

operator in the pharmaceutical factory near the equipment, electronic signature approvals

The Software Development Life Cycle (SDLC) is a process used by InstantGMP to design, develop, test, and maintain software products. Here are the basic steps in a typical SDLC:

Planning: The first step in the SDLC is planning, where developers identify the software requirements which are documented in the User Requirements Specification (URS).

Analysis: In this step, developers analyze the requirements and convert them into Functional Specifications (FS). This includes breaking down the requirements into smaller, more manageable components.

Design: In this step, developers create a Detailed Design Specification (DDS) of the software product, including its architecture, data structures, algorithms, and user interface.

Development: In this step, developers write the code for the software product according to the design specifications. The developer performs Unit Testing (UT) to ensure that the code works as intended.

Testing: In this step, testers check the software product to identify and fix any bugs, errors, or defects. This includes functional testing, integration testing, and Factory Acceptance Testing (FAT).

When the Factory Acceptance Testing is completed by an independent tester, the software is released for Validation which consists of Operational Qualification (OQ) and Performance Qualification (PQ). A new version is ready to be released to customers when OQ is completed.  Customers are responsible for conducting their own PQ.

The image below shows the overall process that is used for InstantGMP which is hosted by Amazon Web Services.  A complete description can be found on our web site page on Validation and GAMP 5 Compliance.

SDLC Process