Agile Computer System Validation

 

Introduction Agile Computer System Validation (CSV) and Software Life Cycle Management

Introducing a validated (software) system in the Life Sciences and Health Care Industry (e.g., regulated projects) can be a very demanding, challenging, and time-consuming task. In this article, we will discuss the following topics:

• What is Agile?

• What is Agile software development methodology?

• What is Agile (computerized system) validation?

• Benefits of Agile software development / Agile validation

• Industry standards & best practices

What is Agile? What is the Agile software development methodology?

Agile is the collective name for any non-linear software development method. Agile software development methodologies are centered round the idea of iterative development, where requirements and solutions evolve through collaboration between self-organizing cross-functional project teams.

Agile is a method of developing software solutions, that focuses on delivering high-quality working software frequently and consistently, while minimizing project overhead and increasing business value

Agile was introduced with the purpose to improve the limitations in traditional development methodologies by concentrating on continuous improvement and conducting tests in smaller iterations without compromising on the overall development quality of the product.

Agile software development is flexible, fast, and aims for continuous improvements in quality.

 

Agile methodology key elements & tools:

 

What is the Agile Manifesto?

Agile development refers to any development process that is aligned with the concepts of the Agile Manifesto. The Manifesto was developed by leading figures in the software industry and reflects their experience of what approaches do and do not work for software development. Read more about the Agile Manifesto.

Core values of Agile Software Development

• Individuals and interactions over processes and tools

• Working software over comprehensive documentation

• Customer collaboration over contract negotiation

• Responding to change over following a plan

 

What is Agile (computerized system) validation?

Agile validation, also called Agile GxP, comes with the help of the methodology based on Scrum (the most commonly used  flavor) to combine the world with requirements for the Life Science and Pharmaceutical industry.

In Agile practice, validation becomes integral component to development, rather than an afterthought. Through continuous verification and validation activities throughout the software lifecycle, Agile catches defects earlier, reducing rework and enable faster system go-live.

Agile validation in GxP projects requires the same type of deliverables that are needed for traditional validation processes, but the way in which these deliverables are created is different. Sometimes the deliverables will have different name.

 

What are the benefits of Agile software development and Agile computerized system validation?

 Agile is a powerful tool for software development and computerized system validation. Examples of benefits of Agile software development are:

• Improved product quality
  
  

  • Focus on high-quality development, testing and (customer) collaboration

  • Continuous Risk management

  • Finding and fixing defects quickly

  • Deliver solutions on time and with a higher degree of client and customer satisfaction (delivering the right product)

• Manage change more effectively
  
  

  • Allows for change; New or changed requirements can be planned and incorporated during development

• Focus on business stakeholder’s engagement
  
  

  • Delivering strategic business value what is aligned with business stakeholders’ expectations

  • Deliver features that provide the most business value to the identified business stakeholders

  • Product features are defined on the need of the real users. Agile software development provides a unique change for stakeholders (e.g., clients, customers) to be involved throughout the whole project

 

• Increased productivity
  
  

  • Agile makes better use of the available resources

  • With work broken into iterations, there are always milestones and deadlines

 

• Improved transparency
  
  

  • Everyone from stakeholders to the development team knows what is getting done, what is not and who is making decisions. When the entire team understands the big picture, projects tend to move forward faster.

 

Standards and best practices

Standard	Organization	Website
GAMP 5 Guide: Compliant GxP Computerized Systems	The International Society for Pharmaceutical Engineering is the world's largest not-for-profit association serving its Members by leading scientific, technical, and regulatory advancement throughout the entire pharmaceutical lifecycle.	ISPE
IEC626604/82304	The International Organization for Standardization is an independent, non-governmental organization, the members of which are the standards organizations of the 164 member countries. It is the world's largest developer of voluntary international standards and it facilitates world trade by providing common standards among nations. More than twenty thousand standards have been set, covering everything from manufactured products and technology to food safety, agriculture, and healthcare.	ISO
Technical Information Report TIR45	The Association for the Advancement of Medical Instrumentation(AAMI) Standards Board has published a Technical Information Report TIR45 which provides recommendations for complying with international standards, and U.S. Food and Drug Administration (FDA) regulations and  guidance documents when using Agile practices to develop medical device software.	AAMI

 

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