Digital Transformation: we have all heard these words at least once. Especially in recent months, in the light of the pandemic. Many companies are dealing with remote contacts, overproduction and the adoption of digital tools in order to continue their business.
Digital Transformation, however, goes beyond the introduction of new technologies, leading rather to a total rethinking of the organisation and posing more cultural than technological challenges.
In the following paragraphs, we will analyse the meaning and impact of digital transformation and what scenarios and challenges lie ahead for the Life Science businesses.
Digital Transformation has been talked about since the late 1990s, as an approach that involves the whole company and introduces changes in the business at a technological, cultural, organisational, social, creative and managerial level.
Digital Transformation encourages participants to share, be transparent and inclusive in the process and places the recipient of the final service at the centre of the development, if not actually participating in it.
Digital Transformation is a ‘gateway’ to the future and to maintaining competitiveness in the marketplace. Companies that have already implemented projects related to the use of new technologies achieve “a profitability that is 26% higher than other companies and a market value increase in the region of 12%”.
According to a SAP report, most companies understand the importance of digital change, but only 3% have implemented digital transformation projects within the company.
Companies that are considered leaders in Digital Transformation have the following characteristics:
For Life Science companies in particular, being part of a digital ecosystem implies easier communication and sharing of data, extending from regulating bodies right up to the patient.
Of great interest in this respect is a study conducted by KPGM on digitisation within the Life Science businesses of Germany, Switzerland and Austria. The research looked at 75 companies, including pharmaceutical, medtech and other Life Science companies.
The departments with the greatest digitisation are IT and Quality Assurance. Quality Assurance is also the area where most digitisation projects are planned. The areas least affected at the time of the research were logistics and production. Although in recent months, there has been a sharp increase in interest and projects in these areas.
Just the increase in efficiency is, according to the research, one of the major benefits of deploying digital technologies, including the agile design of R&D processes (39%). Closely followed by the advantage of optimising Quality & Compliance processes (28%).
Before implementing a technological solution, it is advisable to reflect on our own internal processes. How they can be simplified. Only then should we ask how a digital tool can fit in. Without this prerequisite, there is a risk that instead of increasing productivity, the technologies will lead to further wasted time for the staff using them.
Another issue to consider is transversal collaboration with internal and external stakeholders who will make use of the technology, even if not managing it directly. The advice is to involve them and create cross-functional teams within the company and the group to jointly evaluate and test the new technology, the impacts it will have and how to manage them.
Theagile approach can help with tackling the uncertainty of a new technology and the change it entails, as it allows the best solution to be implemented gradually while making quick decisions. The agile approach involves setting up working groups that are horizontal to the organisation’s hierarchy for rapid prototyping and testing of the best solutions.
Amongst the biggest challenges for more than80% of Life Science companies (KPGM report), are the lack of digital skills and acceptance of new technologies on the part of employees.
The introduction of new technologies might in fact be seen as replacing human activities with the consequent risk of job losses. Therefore, fear of this may lead, consciously or unconsciously, to employees’ resistance to change. If this is the case, management should intercept the fear and convey the message that Digital Transformation is an opportunity to increase one’s skills, remain competitive in the labour market and have the opportunity of changing a repetitive job for a more valuable one within the company.
Companies often employ coaches to help them establish a culture of digital change.
When it comes to lack of digital skills, many companies have undertaken to retrain their employees. Starting with an assessment, they have provided personalised routes for digital growth. Training of this kind certainly involves a significant investment. Many companies in KPMG’s research expressed considerable doubt about their ability to develop such skills.
In this respect, a critical parameter in the digital transformation process is a clear definition of the qualified employee profile that will be required in the future. The training system must therefore adapt to these requirements with specific training programmes.
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Simplify the management of Complaints, from filing, through investigation, follow-up, judgment and final report.
The module is designed to provide step by step Quality Assurance support
in the implementation and supervision of the process and the assignment of tasks to the departments involved. The module supplements the CAPA procedure, which the user can open directly from the Complaints procedure.
PRAGMA-WFM documents and traces all activities and information in the Complaints process. In each phase, you can also attach files in various formats to support activities and investigations.
During inspection phases, the functionality dossier enables the real-time generation of a document that provides information and lists the activities of the process and related processes
It simplifies the management of internal and external audits, from planning, through execution, to the management of remarks.
The module supplements procedures for handling CAPAs , Non Conformitiesand Change Control that the user can open directly from the audit to resolve the observations found.
PRAGMA-WFM documents and traces all activities and information of the Audit process. For each process step, it is possible to assign tasks to the people involved, and attach files in various formats.
Duringthe inspection phase, the dossierfunctioncan generate a document in real time which records the information and activities of the Audits and related processes