Validation using Agile training

Although Agile and Validation feel like a contradiction, Agile development can help you to efficiently validate your systems. Just imagine that during development/implementation of a system the components which are already completed can be used but are also validated for their intended usage.

Rescop Academy can help you with the method and tools to make this imagination become reality; instead of validating your system during the full development and implementation, Rescop Academy’s Agile Validation method will help you to validate parts of a system in an early stage.

Rescop provides Agile Validation using training on various levels: Foundation and Practitioner. Both training levels combine the theory from the Agile (SCRUM) / SAFe, ISPE GAMP® 5 Guide: Compliant GxP Computerized Systems and the AAMI TIR45 guidelines with exercises to simulate the practical implementation.

The Foundation level training is suitable for people who need to be aware what Agile Validation is and how it can be used in a regulatory environment. This training has a duration of 1 day.

The Practitioner level training is suitable for people who are responsible for implementing Agile Validation principles within a Validation Project. This training has a duration of 2 days.

Validation using Agile Foundation

The Foundation level training is suitable for people who need to be aware of what Agile and Scrum is and how it can be used in a regulatory environment. The training includes practical examples on how to do it.

During this training you will learn:

  • How the benefits of Agile development methods can be leveraged within the strict world of compliance (validation)
  • How to implement Agile development methods in practice
  • Differences between small and large projects / programs when using Agile development methods
  • Focus on product / system quality instead of on validation documentation to validate
  • How to apply Rescop Academy’s Agile Validation method to help you to validate parts of the system in an early stage

Validation using Agile Practitioner

The Validation using Agile Practitioner training extends the Foundation training with an even more process focused approach and more in-dept content mostly on multi scrum teams and when to use agile and when not. The Practitioner level training is suitable for people who are responsible for implementing Agile Validation principles within a Validation project / program.

In addition to the content of the Validation using Agile Foundation training, this training will also train you in:

  • How to implement it in using multiple scrum teams (using SAFe)
  • How to maintain the validated state in an Agile environment
  • How to implement continuous improvement (test automation)
  • When to use Agile/Scrum

Program Validation using Agile Foundation

Day 1

Module A – Introduction, Terms and Definitions and Regulations
Module B – Agile (Scrum), including roles and responsibilities
Module C – Epics, Features, User Stories and Refinement Ceremony in a regulated environment
Module D – Planning – Prioritization, different type of Backlogs, Planning Ceremony and
Risk Assessment
Module E – Verification / Testing, DoD, Defect Management and Sprint Review
Module F – Documentation Waterfall (GAMP 5) versus Agile (Scrum)

Program Validation using Agile Practitioner

Day 1 

Module A – Introduction, Terms and Definitions and Regulations
Module B – Agile (Scrum) and SAFe; including roles and responsibilities
Module C – Epics, Features, User Stories, NFRs and Refinement Ceremony in a regulated environment
Module D – Planning – Prioritization, different type of Backlogs, Planning Ceremony and
Risk Assessment

Day 2
Module E – Verification / Testing, DoD, Defect Management and Sprint Review
Module F – Documentation Waterfall (GAMP 5) versus Agile (Scrum)
Module G – Operation – Release & Handover and Maintaining Validated State, Incident Management & CAPA and Change & Configuration Management
Module H – Continuous Improvement, Sprint Retrospective, Regression Testing and Test Automation
Module I – When to use Agile?