Issue link: https://www.e-digitaleditions.com/i/1211868
26 BioPharm International eBook February 2020 www.biopharminternational.com variety of details in the test meth- ods make the digital connection and the design of digital processes more challenging. Furthermore, a CDMO usually has a heteroge- neous customer base with diverse products, which leads to a multi- tude of process variants, such as varying documentation processes. A one-to-one adoption of this vari- ety of paper-based documentation processes in the digital system would lead to a high maintenance effort and thus loss of efficiency. Therefore, it is important to har- monize and standardize the pro- cesses in order to digitalize them using software. Digitalization usually doesn't take place in one single project; it is rather approached as a compre- hensive program containing sev- eral sub-projects. When it comes to processes, these sub-projects often depend on each other and have some correlations. For this rea- son, it is important to determine if there are dependencies between the projects or even possible syner- gies. The digitalization of a process could well affect other projects. Additionally, determining business process ownership may not be as transparent as one might hope. As such, it is important to iden- tify cross-divisional processes and define their ownership in order to sucessfully digitalize them. MAINTAINING FLEXIBILITY While standardization can help a CDMO to reduce overall pro- cess complexity, it is crucial that flexibility be maintained to ful- fill individual customers' needs. Paper-based processes can be flex- ible (e.g., when handling differ- ent filling processes based upon a customer's requirements), but the use of a digital system might affect flexibility because it aims to standardize processes in order to handle them in the system. For example, a CDMO's customers use different wordings in their produc- tion specifications. If not standard- ized, the different wordings result in multiple process variants that would need to be reflected in the digital system. In this case, the use of predefined text modules that cover all important aspects would meet both standardization and flexibility. Digitalization itself will not prevent a CDMO from remain- ing flexible, but the aspect of flex- ibility should be considered in the design of the systems. HANDLING CHANGE T he technica l a nd process ele- m e n t s o f d i g i t a l i z a t i o n a r e important aspects to be consid- e re d w it h i n t he orga n i z at ion, but these are only one side of the coin. Today, technologies are part of our daily lives, and the trans- formation within an organization t hat comes w it h d ig ita li zat ion affects personnel. The organiza- tional culture itself is a system of shared beliefs and attitudes that develop over time within an orga- nization. Thus, when the process is not well explained to staff or the fears of using a new modern technology is not taken seriously, acceptance of the new system can be low. Different educational lev- els of staff, generation gaps, and even vision and corporate mission statements can all affect transfor- mational management. Therefore, the key for many organizations is how to maintain a smoothly func- t ion i ng c u lt u re a nd workplace when the workplace itself changes. W hen it comes to accept i ng a nd u si ng d ig it a l i z at ion, st a f f ca n be d iv ided i nto d ig ita l or non- dig ital natives. T here may be other categories of stakehold- ers that should be considered as we l l, i nc lu d i n g m a n a ge me nt , a f f e c t e d e m p l o y e e s , wo r k e r s ' council, as well as both support- ers and detractors of the project. A sophisticated stakeholder anal- ysis is key to creating dedicated a n d e f f e c t i v e t r a n s f o r m at i o n activities. It is advisable that orga- nizations create a dedicated trans- formation team at an early stage, ideally incorporated into the cor- porate strategy. Partnerships for Outsourcing Outsourcing Digitalization considerations Consider the following key points when approaching digitalization as a CDMO: • Digitalization projects often have a high grade of complexity. The harmonization and standardization of processes are important in order to manage this complexity. • Standardization of processes is a prerequisite for their digitalization but can affect flexibility. • Digitalization brings changes for an organization. A well-established and trained transformation team is advisable. • Don't run digitalization projects for the sake of technology. Rather, focus on digitalization that clearly adds value.