Software Validation Requirements and Excel Spreadsheet Validation

SOCSO Course Category:
Manufacturing

SOCSO Course Code:
HIT3051

Course Title:
Software Validation Requirements and Excel Spreadsheet Validation

Duration:
2 Days

Target Group:

Target Industry:
Medical Device Manufacturing Industry

Certification:
Certificate of Attendance in Medical Device Manufacturing Process Validation by the Association of Malaysian Medical Industries

Methods/ Methodology:

  • Lecture
  • Case Studies
  • Pre-Test & Post-Test

Course Objective

Software Validation Requirements and Excel Spreadsheet Validation is a formalized, documented process for testing computer software and systems. The FDA and other regulatory bodies require Software Validation Requirements and Excel Spreadsheet Validation to demonstrate that computer systems are in compliance with all regulations for electronic data management systems.  Softwares and excel spreadsheets used in GMP or GLP environments, as with any computer system, the regulatory bodies expects measures to be in place to ensure system data are controlled and protected and to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. This training session shall explore the requirements for Software and Excel spreadsheets used in production or the quality system and case studies on how verification/validation can be accomplished.

Course Content

  • Overview of Excel Validation System
  • Types of Software/Computer Validation System
  • Software Category
  • Excel Spreadsheet Development Lifecycle
  • Elements of Excel Spreadsheet Verification and Validation

Learning Outcomes:

Upon successful completion of the training, participants will be able to understand:

  • the requirements for Software and Excel spreadsheets used in production
    the quality system and case studies on how verification/validation can be accomplished
    the measures required to be in place to ensure system data are controlled and protected as well as ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.