Looking back over several years of delivering GxP project consulting in pharma reveals the underlying benefit of specialized project sub-teams. Common project practices rarely supports this benefit, but customers can significantly reduce the risk of GxP project failure, at least sub-optimal delivery.
Regardless of the customer specific project methodology, all GxP projects follow a V-Model-approach to guide business process and requirement specifications, the adaption of the chosen technology and finally testing and validation.
Assignment of specialist teams
Here lies a significant improvement potential for GxP projects in pharma. Instead of assigning the project to a single team, specialized and dedicated service providers for GxP business process analysis and requirement specification, software vendors and their technology experts and GxP validation experts are the better option.
The V-Model of GxP projects enables a much more efficient specialist assignment:
- GxP governance and business leadership team for alignment of the GxP project with strategic business and digitization objectives
- Dedicated Expert Team of Business Process analysts and Solution architects for Digitization, GxP process analysis, requirements specification and integration
- Technology Provider and System Expert Team for Standard Technology delivery and provision
- Dedicated Expert team for GxP validation and life-cycle management
Advantages of dedicated GxP project consulting in pharma service teams
Based on common GxP project roles like Business Process Analyst (BPA), Solution Architect (SA) or Project Quality Manager (PQM), the strategic focus can be set on comprehensive Pharma processes, like Clinical Study Setup in Clinical Operations. Complex processes require strategic governance, program management, the (stepwise) conduct of GxP integrations in several implementation projects.
Optimizations from the perspective of individual Clinical Development functions will not lead to sustainable improvements.
Successful programs anticipate the process transformation beyond the vision and establish adequate expert teams.
How to implement and optimize specialized expert teams?
GxP project consulting in pharma is specialized along dedicated parts along the V-Model. Specialization contributes to higher standardization, effective risk reduction and the delivery in compliance with client-specific rules. Effective customer-GxP project portfolio or program management enables the assignment of expert teams across GxP projects. Expert teams are being assigned according their expertise and specialization and deliver across the prioritized strategic projects.
At this stage it is only a small step to establish either internal or outsourced GxP-services like “BPA as a service” or “CSV as a Service“. Risk reduction and success guaranty included.
intilaris LifeSciences – LinkedIn