Course Description

Validating Software used in Company Processes

Course Description:

This course provides the knowledge and tools needed to validate the software used within medical device companies, including software related to electronic data collection, manufacturing or testing equipment, and process automation (electronic forms, ERP systems, etc.).

This course references ISO 13485 and 21 CFR, parts 11 and 820.

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Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Determine which software needs validation
  • Know what activities contribute to software validation
  • Identify which documentation auditors and inspectors expect
  • Adopt a risk-driven approach to allocate effectively
  • Undertake and maintain software validation within their company

Who Should Enroll:

Personnel involved in the validation of company processes, the implementation of automation tools, the acquisition of software or software-driven equipment, the conduct of internal audits, or the hosting of external inspections, and personnel from quality engineering, R&D, and IT departments are welcome to enroll in this course.

Prerequisite Knowledge/Requirements:

A general understanding of process validation is recommended for this course. 

The following course is recommended but not required:

  • Understanding Software Validation (ID 227)

Subject Matter Expert:

65 min

Related resources:

Case studies:

Basic Account: € 260.00
Premium Account: € 195.00

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