Life Science: Once upon a time, there was a paper-based procedure

The transformation of procedures from paper to knowledge: this was the theme of the webinar organised by LifeBee last March 3, with the patronage of Assolombarda and the original and innovative contribution of Heike Roeder, authoritative voice at international level as executive expert in Digital Solutions for Quality Assurance in Pharma.
A subject that is very important for the future, also in light of the current developments in Pharma.

The webinar, “Digital and 4.0 in Life Science: the transformation of procedures from paper to knowledge”, targeted the SOP (Standard Operation Procedure) totem in its traditionally documental and paper-based form, and shows the way to move from document to data and information, in the spirit of genuine digital transformation of processes and mindsets in Life Science.

A successful strategy, judging by the numbers of the webinar, which saw more than 200 participants from 90 companies, mainly in pharmaceutical, API and Medical Device sectors, but also nutraceutical, homeopathic, packaging subcontractors, production machinery and CROs. And 4 participants from the Medicines Agency.

Felice Lopane for Assolombarda gave a brief and significant greeting, reminding us of the ambitious and realistic Life Sciences Hub project: to aim for the development of digital solutions in industry and healthcare, both concretely on the ground and in close connection with the global movement, not least through the chairmanship of the Health & Life Science task force in 2021 of the B20, the G20’s business counterpart.

Teresa Minero, CEO and Founder of LifeBee, introduced the 4.0 scenario that acts as humus in the digital transformation of Life Science, and is the coherent framework from document management to knowledge management in the case of SOPs.
In the same way, we should not forget why we should adopt the 4.0 approach in its entirety: to have the right information at the right time and in the right place; to support decisions, large and small, always with a perspective of prediction and guidance; to pursue and improve compliance and, ultimately, to provide quality, effective and safe medicines, at the right price, to the patient.

For this reason, Teresa Minero’s LifeBee has been advising Life Science organisations to devise and implement their own roadmap for 4.0, focusing on their areas and goals. A roadmap based on the continuous improvement of processes and which, using the best available methodologies, identifies and defines the projects to be implemented, monitoring their evolution, their path, their budget and their benefits.
Regarding the 4.0 evolution of Quality Assurance processes, recent and settled experience shows and demonstrates the value of the applications of new technologies in predictive analysis for quality management, in the definition and use of KPIs (Key Performance Indicators) for the continuous assessment of processes, in on-demand analysis during inspections and audits, in virtual training for sterile areas, in the categorisation and investigation of Quality Records with the aid of artificial intelligence. Just to give a few examples.
The right framework in which to evaluate the new perspective of digital SOPs: information and knowledge, no longer documents, especially not on paper.

Heike Roeder introduced us to the concept, aims, criteria and practice of digital SOP. A simple idea, revolutionary in its own way, with great cultural value and inviting prospects: moving from documents to information. From the centrality of paper to a focus on process. All processes. A simple idea, which is not trivial without a paradigm shift in mentality and approach. In culture, supported by technology.

The SOP of the future is digital, easy to use, accurate and intuitively easy to understand. It is accessible from anywhere and provides the right information at the right time and in the right place in an attractive personalised format, such as text, voice or image and video.
It is not a distant future, nor is it some kind of luxury: let’s see it.
As it should be, let’s start with the “why”, which in turn is quickly stated.

The reason is well represented by the combination of the evolution of Life Science and the situation of SOPs. Life Science is going through a period of turbulent evolution, with economic pressures, urgent demand for new drugs and vaccines, increasing structural complexity, supply chain transformation, reorganisation, generation change and, at the same time, it has embarked on the road to digitalisation and the increasing adoption of new technologies in many directions.
On the other hand, documentation is increasingly at risk of appearing as a bureaucratic frill rather than an effective support to operations, and with digitisation processes too often resembling ‘paper on the glass’ (which refers to mere digitisation), rather than a real attempt to add digital value.

So, let’s look at the “what”. That refers to what it means to move from documents to data or, if you prefer, to digitalise SOPs in terms of holistic transformation.
It means forgetting about documents, and focusing instead on processes: what information is needed at what time?
No less, no more. This is why processes must be designed, their logical and physical steps must be implemented, and each step must be provided with the necessary information in the most appropriate manner: process principles for the supervisor, work instructions for the analyst, technical diagrams for the maintainer (here the most user-friendly interface technologies may finally be useful). In other words, it is necessary to design a process architecture, to define a flow of information that corresponds to it, and to identify appropriate digital solutions: that manage flows and processes, and information as objects, also in integration with other digital systems, such as MES and LIMS.
It is an important transformation, and we have to observe what values are at stake, also by measuring them: performance, organisation, compliance, flexibility. Values such as culture itself, which is both cause and effect of this transformation.
And it is important “how” to implement the transformation, perhaps the most difficult part.
It is a structured path, defining the architecture and structure of the approach, going through standardisation, integrated process coverage, organisation of information modules. In successive steps from the design of the intervention, to the application in well-defined areas, to incremental roll-outs until the whole organisation is covered.
And should we talk about the company’s attitude, and the implementation team itself? Yes, we should. But time is short: we’ll talk more about this in future webinars.

A quote from Heike Roeder deserves the final space: “Excellent webinar with an impressive large number of experts in the audience. Inspiring to see that digitalization is has reached the industry, the use of innovative digital technologies is progressing. Digitalization offers a new dimension of mastering information in the meaning of “the right information at the right time at the right place”. Especially our SOP Management will benefit from the new digital capabilities to increase compliance, effectiveness and efficiency, and user-friendliness. It was a pleasure for me to share my perspective about the “SOP of the future” and path of transformation towards a data-driven process-oriented information management system.”