The digital age and interconnected processes from R&D, supply, and manufacturing are the main topics of Pharma 4.0 which is seen as the fourth industrial revolution leap applied to the pharmaceutical industry. The roadmap to achieve the benefits of this fourth industrial revolution is through digital transformation [1]. It is not only that we need to look at the technology in a different way, but we also need to oversee the alternatives and think in a more lean, agile, and systematic way. Since one of the main protagonists of the digital age revolution is the agile provision of technology, a logical question is opening – Can and how would pharma organizations benefit from Scaled Agile Framework SAFe in GxP Projects?
What is SAFe?
SAFe is the leading framework for scaling agile principles and lean methodologies across the enterprise. In a nutshell, it is a set of organizations, structures, and patterns intended to guide organizations in scaling their business practices of lean and agile. It is a well-suited framework to transform your operations value streams supported by technology into the digital age and highly needed agility. The main benefits to use SAFe in your organization are transparency, alignment, higher productivity, agility, and time-to-market [2].
Challenges of GxP Project Delivery
For a more detailed overview of agile practice and GxP projects, see our agile transformation in GxP systems implementation blog. Some of the most cited challenges regarding a GxP system implementation and validation are a burden on resources, takes a long time, and is expensive. This is all true in a lot of today’s GxP systems delivery organizations and is a significant roadblock to effective digital transformation.
For an effective digital transformation, one must be able to release GxP systems value quickly, compliantly, and with minimum resources. Therefore, a careful transformation of the GxP delivery organization with Scaled Agile Framework SAFe in GxP projects or an appropriate variation of it is simply a necessity, going forward.
How Pharma IT Can Benefit from Scaled Agile Framework SAFe in GxP Projects?
We have seen that some of the main benefits of implementing SAFe in an organization are faster time-to-market, improved quality, and productivity. These improvements are quite significant and in typical cases result in double digits improvements.
The most pragmatic approach would be to Identify operational value streams in the large pharma IT organizations, which is not a trivial undertaking as it requires a change of the mindset. However, by investigating details on the key business processes which the value streams enable, the departments they serve, and how those departments perceive the value that the technology delivers, the GxP delivery organization will be prepared to make that transition gradually.
For the biggest benefits of the GxP organization and the pharma enterprise in general, the business agility offered by SAFe is going to be a key ingredient in maintaining competitiveness and relevance in the future market.
Therefore, we believe that SAFe offers significant advantages for provisioning technology in pharma processes, and equips the organization with required maneuverability, essential for being able to compete in future markets.
We at intilaris have spent decades in the traditional pharma GxP project delivery manifested in the V-model but have recognized the need to bring agility to the GxP systems implementation to be able to follow the pace of digitalization. Therefore, we have invested in building the skills required to support our customers on their GxP project delivery transformation to agile.
[1] Sandle, Tim. (2019). Digital Transformation of Pharmaceuticals and Healthcare.
[2] Putta, Abheeshta & Paasivaara, Maria & Lassenius, Casper. (2018). Benefits and Challenges of Adopting the Scaled Agile Framework (SAFe): Preliminary Results from a Multivocal Literature Review: 19th International Conference, PROFES 2018, Wolfsburg, Germany, November 28–30, 2018, Proceedings. 10.1007/978-3-030-03673-7_24.
