Shane Loughlin outlines how the pharma industry can comply with the European Medicines Agency's draft guidelines on data integrity during manufacturing, packaging, distributing and monitoring of medicines
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Established in 2002, SL Controls is Ireland’s leading equipment systems integration and system support firm, working with clients in the pharma, medical device, healthcare, food and beverage and technology sectors in Ireland and across Europe.

In November, my colleague and compliance director with SL Controls, Dermot McMorrow, and I hosted a seminar on data integrity for over 100 professionals from the International Society for Pharmaceutical Engineering (ISPE) Ireland and ISPE Young Professionals, held in the Model Arts Centre, Sligo.

The delegation of engineering professionals working in the pharmaceutical industry also enjoyed a tour of the local AbbVie plant. The ISPE Young Professionals event had representatives from AbbVie Ireland, Amgen, Pfizer, SL Controls and industry leaders from other leading pharmaceutical companies.

Data integrity has become a hot topic, following a number of warning letters issued recently by the US Food and Drug Administration and other regulatory authorities related to data integrity along with new draft guidelines issued earlier this year by the European Medicines Agency and the Pharmaceutical Inspection Co-operation Scheme. The guidelines help ensure that data integrity is maintained during the process of testing, manufacturing, packaging, distributing and monitoring of medicines.

My address at the event in Sligo was on the topic of ‘Designing Data Integrity into Equipment’ from a system integrator’s perspective. I began by explaining what Industry 4.0 is and how it will impact on the manufacturing industry.

As we know from our history books, the manufacturing sector has actually experienced several Industrial Revolutions – significant technological changes that changed the industry forever. The First Industrial Revolution came with the introduction of steam power, while the Second Industrial Revolution delivered mass production and the third, supported by automation engineers, is currently delivering highly automated production across a variety of sectors.

We are now on the brink of the Fourth Industrial Revolution (Industry 4.0), which delivers significant efficiencies with the introduction of technologies such as automation, autonomous robots, the Internet of Things (IoT) and cloud computing, which have evolved to transform the way manufacturing facilities are designed, supported and protected.

A significant increase in complexity is required in order to deliver these cyber-physical systems (CPS) that securely integrate computation, networking and the physical processes.

CPS must be designed to support the manufacturing line specifications, scalability and complex settings as well as produce indisputable validation and verification of products. They must remain resilient, confidential and protected against malicious attacks whilst interacting efficiently with the Cloud.

This presents several issues for systems integrators and many manufacturing facilities across Ireland and Europe are experiencing difficulties in responding to these technological advances. To follow are some considerations to make when incorporating data integrity into equipment.

Collaborative tools and interdisciplinary engineering


Shane-loughlin-sl-controls

Shane Loughlin, SL Controls

A reliable network of collaborative support tools which enables interdisciplinary work practices are essential to support the multifaceted systems and equipment needed today.

A primary aim of Industry 4.0 is to deliver hybrid products, which consists of both products and services. When this is applied to manufacturing it enables the application of IT service management (ITSM) techniques to equipment. This novel approach of applying proven IT tools to create equipment service management (ESM) facilitates a step change in the quality of configuration, incident, problem, change and knowledge management for equipment.

Reliable collaborative tools will support Industry 4.0 equipment. They need to be Cloud-based products – Office 365, for example, which allows the equipment systems engineers to interact seamlessly and remotely with the manufacturing equipment, hardware and software on a global basis.

When equipment systems management (ESM) is supported by Cloud-based collaborative tools, such as Office 365, the traditional disciplinary barriers are removed from the process, i.e. data Integrity issues, that may range from mechanical, inspection, control, IT problems and other information is more readily available to all.

A Cloud-based tool facilitates collaboration which breaks down the silos of knowledge associated with ‘engineering disciplines’ (mechanical, electronic, control, etc) and enables the team to focus on the system as a whole, therefore the integrity issues can be resolved more efficiently.

Currently, automation engineers must be highly skilled in various disciplines in order to support Industry 3.0 equipment. Mechanical skills are also fundamental to automation engineering. It is not possible for automation engineers to support equipment unless they understand how it functions mechanically. However, as equipment becomes more complex, so too does the skills needed to manage it.

Industry 4.0 equipment is supported by equipment systems engineers (ESEs). They must have, as a basic foundation, the same skills as automation engineers but require much more complex controls skills. Industry 4.0 equipment typically has extremely complex Inspection, IT and information systems that must be supported. Comprehensive software testing is essential to ensure that the large number of complex systems operate as specified.

It is extremely unlikely that any single engineer will be skilled to ‘advanced’ or ‘expert level’ in all of these disciplines. We need to evolve from the Industry 3.0 multi-disciplinary approach to an interdisciplinary approach that involves the combining of two or more academic disciplines into one activity, for the support of Industry 4.0 equipment.

True interdisciplinary working can be achieved by leveraging equipment systems management (ESM) processes to manage the selection of the team member with the most appropriate skills for the task and utilising a Cloud-based tool like Office 365 to enable the team to collaborate seamlessly on a global basis to deliver the solution.

This approach enables manufacturing organisations, for the first time, to deliver world-class solutions in extremely complex topics such as data integrity and mitigates the risk of poor internal choices being made based on not having access to the required knowledge and expertise.

Considered equipment procurement process


The equipment procurement process (EPP) is the most cost-effective time to ensure data integrity. With the conventional EPP, the equipment is purchased, brought to site, and then integrated into information systems.

The traditional Industry 3.0 EPP does not apply a strong focus to data integrity. It is also quite removed from the true requirements of the manufacturing plant; namely validation, operations and maintenance departments. This approach will not be fit for purpose for the Fourth Industry Revolution. Industry 4.0 requires cyber physical systems (CPS), capable of communicating via the Cloud. The system must be integrated from the start.

Because Industry 4.0 requires CPS that has extremely demanding data requirements, a radically different approach is required. In this new Industry 4.0 world, the EPP must be designed to ensure that the appropriate level of integration is used to achieve the specified requirements of the validation, operations and maintenance for each individual manufacturing plant.

We recommend using benchmarking processes, such as DiVOM, for EPP to ensure that a structured approach is adopted. At SL Controls, we have created a unique process for equipment system Integration called DiVOM, developed in conjunction with Dublin Institute of Technology.

DiVOM stands for ‘Design, Integration, Validation, Operation and Maintenance’. This structured and holistic approach will guarantee that the systems fundamental for achieving data integrity are integrated and tested from the outset and will meet the standard required at the Functional Acceptance Test and Site Acceptance Test stages.

By adopting such a proactive approach to the integration of the required systems in the equipment, there is a much higher probability of achieving data integrity throughout the complete lifecycle of the equipment and systems.

Industry 4.0 is almost upon us – equipment will become significantly more complex, with extremely demanding data integrity requirements, which will require new engineering disciplines, collaborative tools and a successful EPP. However, the emerging technology will allow us to optimise manufacturing facilities and bring about huge efficiency in how they are run along with ensuring that data integrity is maintained during the process of testing, manufacturing, packaging and distributing, to the highest standard.

See: slcontrols.com

Author:
Shane Loughlin, co-founder and CTO of SL Controls, has over 30 years’ experience in equipment systems integration. He is a leading figure in developing Industry 4.0 education through his current position at University of Limerick as a lecturer on the new master’s programme in mechatronics, which he helped to establish.

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Established in 2002, SL Controls is Ireland’s leading equipment systems integration and system support firm, working with clients in the pharma, medical device, healthcare, food and beverage and technology sectors in Ireland and across Europe. In November, my colleague and compliance director with SL Controls, Dermot McMorrow, and I hosted...