Quality & Manufacturing Connect 2026: A Full Day of Real Conversations on Digital Transformation in Life Science

Isabella Mariani

Consulting Service Manager, LifeBee

Digital Transformation Value Framework KPIs to Drive Value Creation

Isabella Mariani opened the technical programme with a structured framework for thinking about value creation in digital transformation – an area where life sciences organisations frequently invest significantly but struggle to measure outcomes.

Her central argument: in life sciences, value must be quantifiable. Digital transformation initiatives that cannot be linked to clear, data-driven KPIs risk turning into box-ticking exercises rather than delivering real business value.

The regulated nature of the environment – GxP requirements, continuous inspection readiness, patient safety obligations – makes this even more demanding. Every KPI must be clearly defined, measurable, assigned to an owner, and associated with a target or threshold.

Mariani outlined a four-step value framework: define the strategy, establish value-driven processes, identify the KPIs that prove whether value is actually being created, and use digital tools to make those KPIs consistent, reliable and available in real time.

Critically, she distinguished between four types of KPI utilisation: descriptive (what happened), diagnostic (why it happened), predictive (what will happen), and prescriptive (what should we do). Most organisations, she observed, remain in the first two categories – and the shift to predictive and prescriptive insight is where digital transformation delivers its most significant returns.

The session concluded with a grounded set of success factors: clear business priorities before digitalization, a small KPI set tied to decisions, strong data governance, and genuine commitment to change management.

Damiano Vedovato

Head of Corporate QMS, Fabbrica Italiana Sintetici (F.I.S.)

Change Management for Enabling Digital Quality Transformation

Damiano Vedovato brought a practitioner’s perspective to the most underestimated dimension of digital transformation: the human side. Drawing on F.I.S.’s ongoing initiative to replace legacy documentation practices with a cloud-based Document Management System – going live in May 2026 – he offered a candid account of what it actually takes to make a digital project succeed across a multi-site organisation of 2,400 people.

His core message was unambiguous: digital projects fail without user adoption. Technology can be implemented and systems configured, but if the end users do not understand the purpose of the change, do not feel adequately prepared, and do not have local support when issues arise, the investment fails to deliver value.

F.I.S. structured its change management approach around four pillars: impact assessment, communication strategy, training, and a change agent network. The impact assessment came first – understanding how the new system would affect roles and daily activities before designing any intervention. Communication was built around a structured plan that distinguished between different stakeholder groups, including company-wide announcements for major updates, a dedicated intranet page with all key materials, and targeted messaging before go-live.

Training was not one-size-fits-all: users were segmented by role and responsibility, with dedicated paths for active users, key users and read-only users. And rather than relying on central communication alone, FIS activated a network of change agents – local reference points who could collect feedback from the field, identify resistance early, and create a direct connection between the project team and the organisation.

Vedovato’s closing recommendations were practical and direct: start early, design effective communication with senior leadership, engage internal ambassadors, allow sufficient time for learning, stick to the plan but build in contingency, and above all, sustain confidence and resilience throughout.

Patrizia Infusino

Validation & Compliance IT Business Partner, Angelini Pharma 

Marco D’Alicarnasso

Global Digital GxP QA Manager, Angelini Pharma

From Paper to Digital – The Evolution of Validation

Angelini Pharma’s presentation offered a detailed account of one of the most technically demanding transitions in pharmaceutical digitalization: moving from paper-based validation to a fully digital, integrated Validation and Qualification Management System.

Before 2020, Angelini relied on manual, paper-based validation processes, with the associated risks of errors, limited traceability and inefficiency. Between 2020 and 2025, a hybrid model introduced digital tools alongside paper – an improvement but still fragmented. From 2026 onwards, the objective is a fully digital and integrated approach that enables continuous compliance monitoring and advanced analytics.

The selection of a Validation Quality Management System (VQMS) was itself a structured process: six vendor demonstrations, three deep-dive sessions, two end-to-end process simulations, reference checks, and a cross-functional evaluation team that included procurement, digital, infrastructure and cybersecurity.

Implementation is structured in waves. Wave 1, covering computerised systems globally, went live in June 2026. Wave 2 extends the approach to equipment modules at Angelini’s Ancona and Aprilia plants, with further waves planned for Albany and additional validation types.

The benefits they outlined are tangible: 30 to 40 %reduction in time spent authoring and approving documents, improved compliance through a unified audit trail, simplified document retrieval for audits and inspections, automated traceability, and real-time visibility across all sites.

The session closed with a quote from the ISPE Good Practice Guide on Digital Validation that captured the broader lesson well: successfully implementing a digital validation strategy requires more than just technology – it demands a cultural shift, cross-functional collaboration, and alignment with organisational objectives.

Irene Ghedin

Quality Excellence Senior Specialist, Johnson & Johnson – Latina Site

Enhancing Line Cleaning Execution and Control through Digitalization

Irene Ghedin’s session was among the most concrete and operationally focused of the day, demonstrating how a targeted digital solution can deliver measurable compliance and efficiency improvements even within the most hands-on manufacturing environments.

The challenge at J&J’s Latina site was specific: ensuring full traceability of line cleaning activities – tracking the start and end times of cleaning, washing and drying steps – while reducing the burden of manual input and review for approximately 500 operators working daily on the production floor.

The original approach involved a paper-based checklist. The limitations were clear: manual data entry, subsequent review of every entry, and the compliance risks inherent in paper-based processes.

The implemented digital solution addressed these limitations through a purpose-built digital checklist that automatically tracked timing through operator signatures, used PIN authentication to speed up the process, ran on touchscreen mobile devices suitable for washing room environments where gloves make standard devices impractical, and included an integrated countdown mechanism guiding operators through correct cleaning sequences. The system also interfaced directly with the MES system for automatic batch data retrieval and automatic archiving of completed checklists.

The results in 2025: approximately 16,700 print operations eliminated per year for cleaning execution alone, a significant reduction in non-conformances related to missing documentation, and a shift to review-by-exception in the cleaning process. By extending the solution to cleaning verification and other areas including Warehouse, Quality Control, QA and EHS, the site executed approximately 77,500 electronic checklists in 2025 in total.

Ghedin’s takeaways went beyond the technical: listen to the voice of the customer, test directly on the shopfloor, redesign workflows rather than simply digitising existing ones, and be willing to challenge the status quo.

Fabio Ceccarelli

Global IT Automation Manager, Kedrion Biopharma

Corporate Digital Plant Manufacturing Journey and Maturity Model

Fabio Ceccarelli presented a more strategic view of digital manufacturing transformation – one grounded in Kedrion’s global programme and structured around the concept of digital maturity.

Kedrion is a complex organisation: seven manufacturing plants across five countries, 75 plasma collection centres in the US and Czech Republic, commercial presence in over 100 countries. Managing digital transformation at that scale requires more than individual projects – it requires a framework for understanding where you are, where you need to go, and how to sequence the journey.

Ceccarelli introduced the Digital Plant Maturity Model (DPMM), developed by BioPhorum, as a tool for exactly this purpose. The model assesses manufacturing plants across six business dimensions – manufacturing operations, process development, quality control labs, quality management systems, manufacturing support and supply chain – as well as two enabling capability dimensions covering people and cybersecurity. Sites are evaluated across five maturity levels, producing a structured baseline from which investments and roadmap decisions can be made.

His account of Kedrion’s Digital Manufacturing Program was transparent about complexity: the challenge lies not merely in implementing systems, but ensuring system integration, process automation, visibility and control, cross-functional collaboration, and effective information management work together as a coherent whole.

On AI, Ceccarelli described Kedrion’s approach as moving from multiple individual initiatives to a more structured and scalable model – approximately 20 AI initiatives already launched, with a focus now on scaling the most mature use cases, building stronger data foundations, and establishing cross-functional governance for AI investment decisions.

Marco Luchini

Manufacturing and Laboratory Manager, LifeBee

Industry Benchmark Results

The afternoon opened with the presentation of the first Quality, Manufacturing and Supply Chain survey – a benchmark study conducted by LifeBee across 60 contributors from organisations of varying size, geography and sector profile.

Several findings stood out. On the level of digitalization: across all domains, 68% of respondents described their organisations as partially digital, with only 3% fully digital and 29% still mostly paper-based. Supply Chain lagged the furthest behind Quality in terms of completed digitalization.

On data integration: only 9% of respondents reported fully integrated data across systems, with 43% still exchanging data manually and a significant share operating mostly in silos.

On innovation approach: large organisations tend to address innovation through multi-site strategic roadmaps and structured pilots. Smaller organisations rely more heavily on local initiatives and external consulting support – a distinction with direct implications for how digital transformation should be structured and supported across different types of organisations.

The top benefits expected from innovation were consistent across domains: operational efficiency, data integrity, compliance and cost reduction. The top risks were equally consistent: resistance to change and fragmented or manual processes.

The survey will remain open until September 2026, with final results and industry insights to be presented in a free webinar in Q4 2026.

Antonia Pascale

Global Quality System and International QA Director, Angelini Pharma

Resilient Supply Chains – Preventing Drug Shortages and Ensuring Compliance

Antonia Pascale addressed one of the most consequential and increasingly regulated challenges in pharmaceutical operations: medicine shortages. Her session combined a rigorous overview of the evolving European regulatory framework with a detailed account of how Angelini Pharma has structured its internal response.

The regulatory context is becoming significantly more demanding. The European Shortage Monitoring Platform (ESMP), launched in February 2025, represents a new centralised digital infrastructure through which Marketing Authorisation Holders must report shortages, submit prevention plans, and provide real-time visibility on supply and demand. The EU Pharmaceutical Reform introduces further obligations: mandatory minimum stocks for critical medicines, expanded ESMP capabilities including predictive risk modelling, and stronger enforcement of Shortage Prevention and Mitigation Plans.

Pascale was direct about the complexity this introduces. Data harmonisation across member states remains challenging. Global supply chain dependencies – particularly for APIs and finished medicines sourced outside the EU – increase vulnerability to disruption. And coordinating the ESMP requirements across a complex international organisation requires governance structures that many companies are still developing.

Angelini’s response has been structured since 2022: a dedicated task force, a single point of contact for EMA communication, a clear shortage detection and reporting workflow, a risk assessment framework for prioritising products, and a documentation hierarchy that links procedure, working instruction, form and register in a coherent system.

Her call to action was precise: keep Shortage Prevention and Mitigation Plans current, ensure reporting through ESMP and to national authorities, and monitor EMA regulatory updates continuously. Proactive engagement with shortage prevention is no longer optional – it is a regulatory expectation.

Roberta Frattini

Executive Consultant, LifeBee

                Sara Costa

Supply Chain Principal Consultant, LifeBee

Smart Supply Chain as Enabler of Operations Innovation

Roberta Frattini and Sara Costa closed the formal session programme with a forward-looking perspective on the strategic role of supply chain in life sciences organisations.

Their argument challenged a persistent assumption: that supply chain is an executional function. In an environment of increasing complexity – more external partners, more regulatory requirements, more volatile demand, more pressure on lead times and inventory levels – organisations that treat supply chain as purely operational are systematically slower, less resilient, and more reactive than they need to be.

The contrast they drew between siloed and matrix organisations was concrete. In a siloed model, Quality, Manufacturing and Supply Chain operate independently, with slow decision-making, information gaps, and misalignment that creates delays and inefficiency across the value chain. In a matrix model, real-time data sharing, integrated performance measurement and cross-functional governance enable faster, better-informed decisions – with supply chain as the connecting function rather than one department among several.

Building a smart supply chain, in their framework, requires four things working together: a strategic role for supply chain across all product lifecycle stages, end-to-end ownership with full value chain visibility, digital enablement through integrated systems, and an integrated performance management approach that generates cross-functional KPIs and actionable insights.

They were also explicit about the organisational requirements: empowered people, a digital culture, sufficient expertise, and a governance structure that aligns execution with strategy while enabling data-driven delegation of decision-making.