Digital transformation: meeting the new demands of quality management in manufacturing
Robert Gaertner, director of strategy for quality at Veeva, explains how digital transformation is improving pharmaceutical processes across the industry.
Advancing digital technology is bringing new opportunities to improve quality and efficiency in the pharmaceutical industry. Many life science organisations are transforming manual and document-centric processes into more data-driven ways of working. They are replacing a formerly siloed system landscape with unified and connected applications.
In pharmaceutical manufacturing this addresses long-standing inefficiencies, placing product supply units in a stronger position to meet future demands. It is important for manufacturing operations to become more agile, while embracing the new paradigm of precision medicine. Enabling the creation of a connected shop floor allows for real-time visibility across data and processes for better tracking and analytics. This is a pre-requisite for adaptive manufacturing and continuous improvement.
Precision medicine transforming processes
Enabling technologies such as cloud computing, artificial intelligence, and the Internet of Things have reached enterprise-scale maturity. However, the real driving force for transformation will be changing market demands. In 2018, the FDA approved 62 new therapeutic drugs, of which 25 were precision medicines (1). This emerging approach to disease treatment targets a patient’s unique molecular and genetic profile and therefore requires changes in the way that products are manufactured. Typically, precision medicines are made for small groups of people with hard-to-treat illnesses. The reality is that they can be complicated to produce and difficult to scale.
Additionally, with many precision therapies, the patient becomes an integral part of a highly specific end-to-end manufacturing process. For example, with chimeric antigen receptor (CAR) T-cell therapy, approved for relapsed and refractory leukaemia and lymphoma, the patient’s cells are collected at the hospital, shipped to a manufacturing centre for engineering to target the person’s specific cancer, and then sent back to the hospital for infusion into that patient.
Traditional, large-scale drug manufacturing processes are not aligned with this highly individualised approach. The success and scalability of personalised medicine requires new strategies for automation and improved workflows to produce them reliably, safely, and economically.
The opportunity for change
What are the levers to get pharma manufacturing more agile, data-driven, and ready for future demands? As an example, much of the information on the pharmaceutical shop floor is currently buried in paper binders or siloed applications. Without centralised systems for tracking and distributing content and intuitive applications that offer quick access, operators are not able to easily consume the right information they need to perform their jobs. This increases the risk of human errors. Significant overhead is required to ensure that Standard Operating Procedures and Work Instructions remain current and followed by every employee.
In addition to the challenges with document-centric instructions, the systems landscape is mainly disconnected and based on ageing technology. Companies may try to get as much value as they can from their quality management and manufacturing systems by operating them past their shelf life. This practice can actually increase costs because ageing systems tend to be over-engineered, customised, and require frequent maintenance. Older systems are often too rigid to adapt to new processes, manufacturing or training methods, or production requirements, and they cannot efficiently scale down for small batch production required for precision medicines.
Matching up to other industries
The life sciences industry has continued to lag behind other industries in the adoption of new technologies. In fact, a recent survey by Deloitte with MIT Sloan Management Review showed that only 20% of biopharma companies are maturing digitally (2). However, meeting the requirements for innovative therapies, such as precision medicines, depends on the industry’s ability to leverage modern solutions. This is key to enabling timely delivery of information to the plant floor and improving agility.
One of Veeva’s customers, a large contract development and manufacturing organization for biologics, is taking a fresh approach to ensure they remain efficient and agile as they scale. Leveraging modern technology and its parent company’s manufacturing expertise and experience, the organization is progressively building larger and more advanced facilities that can run continuously 24 hours a day, seven days a week.
Going mobile for greater plant agility
Mobile devices are ideal for collecting and distributing real-time information to the plant floor and eliminating paper as the main source of information. Using tablets, operators and technicians can deliver updated content and collect data that can be analysed for improved visibility and efficiency. Cloud applications designed specifically for the manufacturing plant floor run on mobile devices and support manufacturing processes, with up-to-date content and seamless integration with quality management systems.
Synchronising content on mobile tablets at each work station has many benefits. First, the content is completely accessible to operators, including for offline viewing. This eliminates having to page through stacks of paper to find the right instructions.
Second, mobile applications provide real-time visibility into quality events, allowing manufacturing and quality teams to address and resolve issues quickly when they first come to light, before they have a bigger impact. For example, with a tablet, workers can detect deviations right on the plant floor and enter them immediately at the point of observation, permitting rapid triaging, impact assessment, and remedial action as quickly as possible.
Human error prevention with improved training methods
A connected shop floor supports training methods that provide the flexibility and versatility needed in modern manufacturing. Information, such as relevant digital procedures and work instructions, can be presented to workers at specific points in the manufacturing process, reducing complexity and, with it, variation.
This targeted learning approach is replacing passive “read and understand” instructions, ensuring measurable training effectiveness. Companies can expect better results from training programs that are shifting from individual, content-driven events to learning that is deeply contextual, social, and embedded into the flow of everyday work (3). This approach ensures that individuals are not just qualified but also prepared to do their jobs.
Training platforms that apply these techniques are catching on in the life sciences industry. By connecting learners with training content at the time of need and according to specific learning styles, companies can change behaviours to decrease quality events. Mapping training content to learner roles based on job functions, then delivering it through a role-based, content-centric experience simplifies training, while making it more cohesive and integrated with quality goals.
The future of quality management
Transforming quality management is key to successfully gaining the agility needed for the production of new therapies. Next-generation solutions that emphasise flexibility and efficiency position manufacturers to reap enormous benefits in simplifying and improving quality management.
To meet current and future needs of patients, life-science companies can enable processes that are flexible and always compliant. Eliminating siloed systems in favour of streamlined solutions allows for greater agility and stronger collaboration, while enhancing compliance and end-to-end control. This will help enable life-science organisations to meet the new demands of quality management in manufacturing and help support innovation in precision medicine.
References
- Personalized Medicine at the FDA, Progress e Outlook, Personalized Medicine Coalition, http://www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/PM_at_FDA_A_Progress_and_Outlook_Report.pdf
- “Survey Finds Biopharma companies lag in digital transformation,” Deloitte Oct. 2018 https://www2.deloitte.com/insights/us/en/industry/life-sciences/digital-transformation-biopharma.html
- “Corporate Learning Programs Need to Consider Context, Not Just Skills,” Harvard Business Review Nov. 2017 https://hbr.org/2017/11/corporate-learning-programs-need-to-consider-context-not-just-skills
- “Survey Finds Biopharma companies lag in digital transformation,” Deloitte Oct. 2018 https://www2.deloitte.com/insights/us/en/industry/life-sciences/digital-transformation-biopharma.html