IBSA and the digitisation challenge: the Electronic SOPs13 January 2022
One of the critical issues that the companies in the pharmaceutical sector must address with particular attention is that related to quality. In order to offer patients effective and safe therapeutic solutions, IBSA works with care and attention in all business processes, and has precisely made the Quality Assurance department the protagonist of the Digital Transformation, through the process of digitisation of documents and quality flows.
On last November 8, 2021, at the IBSA headquarters, a new system was launched for the management, storage and electronic consultation of quality documents, specifically SOPs (Standard Operating Procedures). This platform now allows to electronically implement the entire life-cycle management of these documents.
The system was first adopted by IBSA’s quality complaints management in Switzerland, where it has been in use for over a year. This digital management of complaints led to the dematerialisation of paper for quality flows. Then, the addition of electronic SOPs consolidated the result, also integrating the electronic management of quality documents. This implementation constitutes an important milestone in the digitisation process of IBSA’s quality flows and documents in Switzerland and Italy, as well as at its partner, Altergon.
The adoption of this system does not only translate into a significant reduction in paper consumption: digital management allows to simplify and optimise the review, approval, distribution and reconciliation flows of paper documents.
The supply of adequate tools was an essential aspect for the success of the project; for this reason, the distribution of IT devices has been extended to premises that were previously non-computerised. We installed 120 new PCs, which allowed a widespread coverage of all production premises and laboratories. In this way we ensured the possibility of accessing quality documents wherever it is necessary to consult them.
The collaboration of a cohesive and motivated multi-department team, coordinated by the Quality Assurance and Information Technology departments, was critical for the success of this digital transformation. This collaboration made it possible to evolve into a digital dimension what until yesterday had been handled in paper form, while allowing the company to critically analyse the processes in place, by exploiting the experience of years of use to direct them towards a new digital reality.
Finally, the new digitisation system of quality flows and documents – which has obtained the Swissmedic authorisation – translates into reality IBSA’s sustainability path. With the implementation of this new system, in compliance with the cGMP (current Good Manufacturing Practices) regulations in force, IBSA renews its pledge to innovation, meant as an intrinsic value of its modus operandi, both in terms of products and operational processes, thus confirming its propensity to increasingly raise its quality standards.