Online Training – Software Validation

Online Training – Software Validation

July 5, 2022

Jadwal Pelatihan Online Training – Software Validation

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DESKRIPSI

Software is a computer program that acts as a liaison between the user and hardware (Hardware). In software project management, software testing, and software engineering, verification and validation (V & V) is the process of checking whether the software system meets the specifications and fulfills its purpose.

This Method of Software Validation is a tool intended to assist in validation of small and medium scale software used in accredited and other laboratories where software validation is required. The main requirements to the laboratories are stated in the Standard ISO/IEC 17025

With the transition of many medical device companies to ISO 13485:2016 “Medical Devices – Quality Management Systems – Requirements for regulatory purposes”, it is a challenge for the industry to obtain suitably qualified software validation engineers to fulfil its requirements.

 

MATERI Training Online – Software Validation

  1. Introduction
  2. Principle of Software Validation
  3. Typical software V&V protocol / test report
  4. Manufacturing Production Machine Software Validation (PLC)
  5. Labeling Software Validation
  6. Quality system Software Validation
  7. Measuring Equipment Software validation
  8. Software validation requirement ISO 13485 and 80002-2
  9. Major industry failures
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