Quality Assurance in the Pharmaceutical Sector

“Our goal is not the mere transposition of paper documentation to a digital medium, but the redesign of the quality process enabled by digital technology to make it more efficient, faster, visible, accessible and in compliance with the Data Integrity requirements of the pharmaceutical sector. We want to transform every document into a new digital and integrated process”.

 

Marco Torciani, LifeBee Partner

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In Life Science, product quality, efficacy and safety are the three main aspects at the base of the process to guarantee the final consumer of the product: the patient; it is not casual that those are the three main aspects evaluated by the pharmaceutical regulatory system to authorize a product to the market. They are regulated through specific laws and monitored during the whole life cycle of the product through frequent inspections and audits. According to several reports, companies invest in controlling these aspects more than a quarter of their turnover and up to 70% of their time. After all, a product of inadequate quality generates exponentially higher costs that grow as you proceed from the production stages to distribution to the final customer. According to an established rule of thumb, poor quality generates ten times higher costs than prevention, if it is identified during internal verification procedures, and even one hundred times higher if the product has already been sent to the customer, not to mention the brand reputation and legal aspects (in particular those concerning pharmaceutical regulation).
Several companies, even recently, have gone bankrupt precisely because they have not complied with GxP regulations, in particular GMP as regards the rules of good manufacturing, in which Quality falls.
At this stage, with the ongoing digital revolution and increasing consumer sensitivity to ethical and social aspects, the concept of quality is further expanding, and the Covid-19 pandemic has provided a new boost to this process. According to some analysts, in the last 10 months the biopharma industry has advanced in the digitalization process more than it did in the previous 10 years, and an unprecedented development of artificial intelligence, machine learning and IoT (Internet of things) solutions is now expected. The deployment of these new technologies offers an unprecedented and crucial opportunity to overhaul the entire workflow and make it more effective, productive and cost-efficient. In this context, the simple transfer of Quality document management systems on digital support is limiting, because it does not allow to capture the full potential of renewal and efficiency offered by new enabling technologies.
With digital transformation, Quality Assurance procedures will be strengthened, thanks to solutions that will make activities increasingly effective and automatic: algorithms to detect and classify quality events, detection sensors, data processing and analysis systems. The role of Quality Assurance itself is changing, going beyond the objective of meeting regulatory requirements. As Marco Torciani, Partner at LifeBee, explains in this interview, the process review generated by Quality Assurance can now provide a decisive impetus to the evolution and efficiency of workflows.

What have your customers achieved in Quality Assurance through LifeBee Consulting and Design?

In over 15 years of national and international experience, we have seen a number of real benefits for our clients, starting with reducing paper, improving governance, increasing the level of collaboration between different areas, and ending with a significant increase in Data Integrity that could not be achieved with paper or the mere digital transposition of processes without a true redesign. In quantitative terms, companies are reducing Quality Record management time by more than 50%, queuing by 20% and increasing the number of identified quality events (quality records) by more than 40%, as shown by several surveys of leading digital quality players.

What approaches and methods do you use to achieve these results?

Our goal is to build digital systems for document management and quality management through a holistic approach to design, driven by deep expertise and knowledge of processes and regulations in multiple operational areas. Our goal is to capture the essence of a procedure, an operational instruction contained in a paper document and transform it into a new digitalized process that is integrated within business systems. It is an all-round vision, which rises from the analysis of the detail to embrace a comprehensive review of the organization and its quality and document management processes. It is a unique approach, possible only thanks to LifeBee’s great experience in projects carried out in partnership with the most important local and international digital solutions companies for quality, different in structure, size and specificity.

Can you give us some examples of successful projects?

We recently accompanied a strategic client, an Italian multinational pharma company that, following the acquisition of a portfolio of products and a U.S. production site from a large global pharma company, decided to take the opportunity to implement a corporate quality assurance process management system. It was a challenge made particularly complex by the fact that it required the implementation of a digital technology, particularly new and innovative, having to comply with complex regulatory requirements at local and international level in a very tight timeframe and with the primary objective of achieving a right first result, as there was no margin for error for business reasons.
We organized a project team – in partnership with the client and the digital solution vendor – that analysed the situation in detail and drew up a detailed plan of all the activities to be carried out. Thanks to this careful planning, we were able to complete the task on time and achieve significant cost savings for the client. In order to meet the deadline, we had to complete the project in about 5 months (normally a project of this magnitude requires at least twice that amount of time) but, despite this, the client achieved the additional goal of saving more than a third of the budget he had reserved for this project.

What are the critical issues you encounter and how do you address them?

I would say that there are three main criticalities. The first concerns the mindset: there is a certain reluctance on regulated issues to get people to really brainstorm when redesigning processes. There is a certain propensity to reproduce what you do with paper on digital. Our job is to change the model to take advantage of the innovation that technology brings. We approach this with patience and experience by guiding the client to the industry’s best practices that guide us in analysing client requirements.
Then, there is the Change Management factor: the introduction of a different way of working, at all levels, in a complex and often multinational organization is one of the most critical and difficult aspects to manage. We deal with it by preparing the project team from the very first moments of the project, first of all, and by providing guidelines to establish the foundations of change throughout the organization. We do this through communication and engagement, to make everyone feel part of this change, in a positive way. In addition to this, clear and explicit internal management sponsorship serves the function of facilitating change.
Finally, there is an element linked to the expectations on the project (Right First and Continuous Improvement): when it comes to redefining the processes that impact the organization there is always the desire to be able to intercept all possible exceptions at the table and define everything at the highest level of detail to build the perfect process, based on the organizational complexity of the client. This is the common goal, but approaching it with the awareness that not everything will be perfect at the first round is fundamental in order to arrive at a solution in a reasonable timeframe, even if not perfect, but which immediately brings value to the organization. We approach it by involving the client in implementing a process of continuous improvement following the use of the system to ensure the continuous adherence of the digital solution to the evolving organizational context.

Can you describe the spectrum of your consulting services?

We provide process optimization analysis, design, configuration, integration, testing, compliance support and lifecycle management of applications. In particular, we optimize physical movement and waiting times, ensure a secure approval cycle by enabling remote work, provide ad-hoc tools and analytics for continuous process measurement and optimization to ensure data integrity. We identify digital solutions suitable to each customer that allow a better and safer management of information – which are controlled and always available, even in case of inspection by a regulatory body or a sponsor/customer – an easier archiving and cataloguing of documents along the entire lifecycle, and integration with other business systems (such as ERP, LIMS, MES/EBRS) to improve traceability and data integrity – which in pharmaceuticals is a must –, as well as mitigate the impacts of human error in the information flow between the various functions involved in ensuring product quality.

Why do your customers choose LifeBee to evolve the level of quality assurance?

LifeBee has twenty years of experience in the Life Science sector, with over 600 projects behind it, and can address any issue with a deep knowledge of the entire production process and its quality, of the relationships between the various areas and business functions, and of the impacts – positive and negative – that any change can have on the entire process. In the field of Quality Assurance – particularly in the pharmaceutical industry – this competence is a fundamental added value because it is a transversal function that necessarily crosses all areas subjected to the pharmaceutical regulatory system to ensure compliance with requirements.
Thanks to the Best Practices defined by our multiannual experience and the experience of our partners – ranging from market leaders to more agile and adaptable realities – we can analyse the specific business context with the customer, in order to identify tailored solutions that respect the specific needs and also any criticalities of the company and enhance its distinctive components.