Digital: Real-Time Qualification

What’s the evolving impact of digitalisation on life sciences operations, and how can a systems-engineered approach help to create more resilient, flexible and future-ready compliant thermal processes?

Roberto Zerbi at Watlow

Regulatory compliance is a fundamental requirement in the life sciences industry, ensuring the safety, efficacy and quality of medicinal products throughout their life cycle. Regulatory agencies such as the US Food and Drug Administration, European Medicines Agency, and UK Medicines and Healthcare products Regulatory Agency enforce stringent guidelines to minimise risks, maintain product quality and safeguard public health. However, as regulatory frameworks evolve, manufacturers face increasing challenges in maintaining compliance while optimising production efficiency.

The rapid advancement of digital technologies is reshaping how compliance is managed. Big data, the Internet of Things (IoT), artificial intelligence (AI) and advanced analytics are transforming regulatory adherence from a rigid, unchanging set of instructions – applied without flexibility since initial approval – into a dynamic, knowledge- and risk-based approach that encourages innovation, continuous improvement and the adoption of new technologies.

Trusted digital data, control methods and advanced analytics finally make the Quality by Design (Qod) approach applicable to operations, securing data integrity principles while increasing efficiency and flexibility.

The challenges of compliance in life sciences

Regulations require that manufacturing processes be validated, monitored and controlled to prevent the risk of contamination, process tweaking or any alteration in the compounding formulation that could compromise the medicine. Any deviation from the master recipe, pharmacopeia or other good manufacturing practices (GMP) can lead to warning letters and severe consequences, including product recalls, production halts and reputational damage.

One of the primary challenges newly appointed qualified persons face is to keep up with the increasing complexity of GMP requirements. They need time to familiarise themselves with the production processes and make the correlation with ‘half a dozen’ of complex regulations. It goes without saying that newcomers often struggle to enter the life sciences sector, preferring faster and more immediately rewarding career paths.

Data integrity is another critical concern. Regulators emphasise the importance of maintaining accurate, reliable and tamper-proof records throughout the product life cycle. However, traditional paper-based systems and manual data entry processes are prone to errors, time-consuming and require properly trained personnel. This has led to a growing focus on digitalisation to enhance compliance, using data analytics to improve operations’ efficiency, sustainability and energy saving.

The role of digitalisation in compliance and manufacturing

Digitalisation, boosted by AI and large language models agents, is playing an increasingly important role in reducing the compliance burden in life sciences. Studies show that having access to trusted data – combined with investment in augmented analysis and predictive capabilities – offers significant benefits to rapidly test laboratory models, increase confidence on conceived ‘design spaces’ and enhance process control. Digitalisation and data integrity are tightly bonded. Data integrity is not just a regulatory obligation; it is the most effective safeguard against the ‘garbage in, garbage out’ effect.

Good data is no longer seen as a constraint or limiting factor but rather as a powerful tool enabling operations to track critical process parameters, quickly detect deviations and take corrective actions before non-compliance issues arise. Predictive analytics further strengthen compliance by identifying potential risks and trends, enabling proactive decision-making rather than reactive problem-solving. Data enables better equipment utilisation and helps to realise the goal of predictive maintenance. Automatic scheduling of environmental parameters and calibration rounds is possible.

Another key advantage of digitalisation is its ability to streamline compliance reporting. Automated documentation systems reduce the time and effort required to compile reports for regulatory submissions, ensuring that data is structured, complete and readily accessible. This not only facilitates audits but also allows organisations to allocate resources more effectively, shifting focus from manual record-keeping to continuous process improvement.

A systems-engineered approach to compliant processes

To address the increasing complexity of compliance requirements, technology providers are adopting a systems-engineering approach aligned with frameworks such as ISPE GAMP5.

In strict adherence to the ISPE GAMP 5 (2nd edition) guidelines, a range of digital engineered solutions (DES) has been developed for selected GMP-critical thermal processes and equipment.

AI-driven analytics further enhance monitoring capabilities by correlating environmental fluctuations to the production process and to the way operators interact with the equipment, resulting in knowledge on how to enhance production.

This methodology integrates compliance considerations into the design and operation of manufacturing systems, ensuring regulatory adherence at every stage of the process life cycle. One of the core principles of this approach is life cycle data management. By preserving contextualised data and alarm traceability over the process operating life, regulated companies can compare different batches even from multiple sites and production lines.

Modularisation and internal quality management systems are leveraged to decrease the ISPE GAMP hardware and software categories – reducing the documentation burden and the tests – with benefits on delivery and commissioning risks, cost and time.

Since DES solutions are continuously updated as part of standard service agreements, updates and enhancements can be deployed without risk or prolonged production stops. Changes required by operations can be analysed in advance using a digital twin and confidently deployed.

One capability of digital solutions is that young plant and process engineers can apply their skills and passion to try to improve the operations without disrupting production. Working on the shop floor is no longer just a matter of executing a recipe, but could be a place for creativity and personal enrichment.

Environmental monitoring: a case study in compliance-driven system design

Environmental monitoring is a critical aspect of compliance in biopharmaceutical manufacturing. Strict regulations govern critical process parameters such as temperature, humidity, pressure, air changes, and viable and non-viable contamination to ensure that manufacturing environments remain within specified limits during different operating phases. Non-compliance with environmental conditions could result in amendments to the batch report or even product scrappage.

Some digital environmental monitoring systems (EMS) offer high accuracy and repeatability with redundant local storage for data and alarms at the edge. These features help to avoid losing data and reduce the number of alarms, resulting in faster product release, as exception-based batch reports contain fewer events to record.

Advanced EMS can leverage IoT-enabled sensors and cloud-based platforms to provide remote access to critical data, enabling proactive risk management and recommending corrective actions before deviations impact production.

Seamless integration with manufacturing execution systems and risk management platforms allows for limited effort in setting up EMS solutions and reduces the burden of manual documentation without reliance on automation experts.

Conclusion

The regulatory landscape in life sciences is becoming increasingly complex, requiring manufacturers to adopt more sophisticated compliance strategies. Some digitalised solutions could offer enhanced data integrity, real-time monitoring and predictive analytics to improve regulatory adherence. However, simply implementing digital tools is not enough. A modular and systems-engineered approach ensures that compliance is integrated into the design and operation of manufacturing systems, supporting a continuously current and resilient regulatory framework.

Environmental monitoring serves as a clear example of how a compliance-driven system design can enhance both regulatory adherence and operational efficiency. By leveraging contextualised data, alarm management and predictive analytics, organisations can reduce compliance risks while optimising manufacturing processes.

By embracing these advancements, manufacturers can position themselves at the forefront of a dynamic industry, delivering both compliance and innovation in equal measure. By fostering agile, efficient and future-ready manufacturing environments, they not only meet today’s regulatory challenges but also shape the future of life sciences manufacturing.