AGILE Validation in GxP Project Service

[ Consulting ]

Leading experience with all technologies used in Clinical Development.

The key success criterion when using Agile Validation in GxP project is the close collaboration with the quality organization to align the agile approach.

Implementing Agile practices in pharma companies is considered quite challenging and implementing Agile validation in GxP project is no different. The situation is convoluted even more by highly specialized staff, sequential way of working and the overall industry culture with focus on stability and process orientation. However, due to exploding costs of pharma R&D, new ways of working are necessary to bring those costs down, improve productivity and foster innovation. Agile ways of working in alignment with the digital transformation, are proving capable to support pharma industry to deal with those challenges and open the full potential of the organizations.

Agile in practice

Over the past 2 decades, Agile has been adopted and giving better results in many industries, including those with mission-critical requirements, safety, and reliability. However, the uptake in the pharma industry has been slow. The main objection is focused around the concern that pharmaceutical products need to be safe, effective, and reliable without causing any undue risks to the patients. This has been magnified by a misconception that regulators (e.g. FDA) prescribe a waterfall process. The reality is that Agile methodology, appropriately applied with quality system regulations, improves the reliability, safety, and effectiveness.  The regulators, on the other hand, do not prescribe a development methodology, rather they recommend that software validation and verification activities be conducted throughout the entire software lifecycle.

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 project

Introducing a validated software system in pharma organization can be a very demanding, challenging, and time-consuming task – just ask anyone with a recent experience of it. Even a non-validated system implementation presents quite a challenge these days, let alone a validated one.

The objective of Agile Validation is to ensure the complete documentation and traceability of all changes, and to make the process of validating a computerized system in pharma organizations:

  1. giving clear vision behind the Agile transformation
  2. being part of the organization’s culture
  3. leading to development of new skills
  4. enabling effective progress monitoring

Agile Validation in GxP project requires the same documents that are needed for traditional validation processes, but the way in which these documents are created differs.

Agile validation in GxP project service

The way in which Agile Validation meets the computer system validation (CSV) requirements, differs from the traditional methods. A key success criterion when using Agile Validation is close collaboration with the quality organization to develop the specific approach to meeting the computer system

validation specifications. Based on the intended use of the computer system the extent and applicability of the CSV requirements differ. We work closely together with client’s quality organization to fine-tune the Agile approach, ensuring delivery of the benefits of Agile while providing a validated solution in compliance with the regulations. We will support you to establish the key elements to ensure the success of your Agile transformation:

  • senior management sponsorship and support
  • utilization (or implementation if they do not exist) of validated supporting systems
  • direct and permanent involvement of quality and compliance in the Agile team
  • align quality organization with Agile thinking

Once the key elements are in place, we will support you in aligning traditional validation and Agile Validation through:

  • Roles and responsibilities
  • Validation planning
    • Product Vision
    • GxP and Risk Assessment
    • Data Classification Assessment
    • Supplier assessment and evaluation
    • Validation Plan
  • Scrum-based design, build and test phases
    • Product backlog
    • Sprints
    • System architecture
    • Detailed Features, Epics, and User Stories
    • Design specification
    • Build (Code, review/unit testing)
    • IQ, OQ, PQ testing
  • Validation reporting
    • System deployment
    • SOPs update (or definition) and training
    • Validation Report
  • Operations and change planning

Supporting you

to implement the agile ways of working in alignment with the digital transformation for the verification and validation activities throughout the system lifecycle.

For an in-depth conversation on this topic, please reach out to us.

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