QRM Process / Software

Modernizing manufacturing through a connected shop floor

Eliminating siloed systems in favor of streamlined applications allows for greater agility and stronger collaboration, enabling pharma to meet the new quality management demands

By Michael Jovanis, vice president, Vault Quality, Veeva Systems

The shop floor is ripe for digital transformation. Manufacturing operations are still mostly paper-based, with aging systems also in use long past their shelf life. Adapting to new processes, manufacturing or training methods, or production requirements is difficult because processes are manual and systems are rigid or function in silos.

As a result, companies are modernizing manufacturing operations with advanced mobile applications that can bring workstations online and significantly improve agility and efficiency, while maintaining quality and compliance. With a connected shop floor, facilities can support 24/7 manufacturing and manufacturers gain real-time visibility for greater intelligence and smarter decision-making.

“Companies want to create smarter, more agile manufacturing facilities,” said Jan Paul Zonnenberg, operations management consulting partner for pharmaceutical and life sciences companies at PWC, the global auditing and consulting firm. “By digitalizing their content management and delivery, manufacturers can ensure operational alignment and empower teams with access to the information they need.”

Modern cloud solutions are helping companies seamlessly bring together people, processes, and technology – accelerating their digital transformation and transition to a connected shop floor.

Building operational agility

The rise of precision medicines and complexity of supply chains combined with disruptive events, such as natural disasters or political instability, are forcing companies to re-evaluate their business agility.

Precision medicines hold tremendous potential to transform clinical practices. The Food and Drug Administration approved an all-time record 62 new therapeutic drugs last year, of which 25 were personalized medicine therapies. Typically made in small volumes, these therapies can be complicated to produce and difficult to scale. Traditional, large-scale blockbuster drug manufacturing processes are not aligned with the production of highly individualized medicines. The success and scalability of personalized medicine requires new strategies for automation and improved workflows to produce these therapies reliably, safely, and economically.

Going mobile for responsive manufacturing

Today, much of the content on the manufacturing shop floor is only accessible in paper binders or siloed applications. Without digital distribution of procedures and work instructions, it is hard to keep information current when there are frequent updates, or changes when sites or manufacturing lines produce new products. Companies face intense pressure to quickly get finished goods out the door, and any delay impacts revenue. 

The life sciences industry continues to lag many other industries in adoption of new technologies. In a recent survey by Deloitte with MIT Sloan Management Review, only 20 percent of biopharma companies are maturing digitally. Leveraging solutions to enable timely delivery of information to the plant floor and tying real-time data with quality management systems can improve agility and help manufacturers meet requirements for innovative therapies such as personalized medicines.

Cloud applications designed specifically for the manufacturing shop floor run on mobile devices and support manufacturing processes with up-to-date content and seamless integration with quality management systems. A connected shop floor can drive greater manufacturing agility, and mobile devices are ideal to deliver and collect real-time information.

Devices such as tablets can deliver updated content to operators as well as provide real-time visibility into quality events so teams can quickly address and resolve issues before they have a bigger impact. For example, deviations detected on the shop floor are immediately entered into a tablet at the point of observation. Instant visibility into deviations and other quality events allows for rapid triaging, impact assessment, and remedial action as quickly as possible.

Companies like Samsung BioLogics, a large contract development and manufacturing organization (CDMO) for biologics, are adopting technology to ensure they remain efficient and agile as they scale. “In the current medicine era, CDMOS must adapt their manufacturing facilities to support multi-drug demands,” said James Choi, chief information officer at Samsung BioLogics. “With modern technology and automated processes, we are reducing the time it takes and number of batch losses suffered when switching between products.”

Enabling 24/7 manufacturing

With paper-based processes, significant overhead is required to ensure the content that workers need to complete tasks is current and easily accessible. Companies that have invested in legacy systems have also realized these solutions cannot reliably support continuous uptime and there are long scheduled downtimes due to system maintenance, upgrades, and re-validation.

Shifting to a 24/7 manufacturing facility increases utilization of equipment and sites and enables companies to be more responsive to business demands. Modern cloud solutions are designed to have continuous uptime. Information is always accessible to operators, including for offline viewing. Synchronizing content onto mobile tablets at each work station allows operators to quickly access correct information at the point of need to perform their job. Eliminating paging through stacks of paper to find the right instructions drives greater adoption and increases operator compliance – potentially leading to fewer deviations.

Increasingly, pharma manufacturing sites – especially at contract manufacturing organizations – are transitioning to a continuous operating model. Leveraging modern technology and its parent company’s manufacturing expertise and experience in other industries, Samsung BioLogics is progressively building larger and more advanced facilities that can run continuously 24 hours a day, seven days a week.

“It’s challenging to manage, maintain, and provide continuous access to current information on the manufacturing floor,” said James Choi, chief information officer at Samsung BioLogics. “Delivering content directly to manufacturing stations through a mobile application – that also offers offline access – will ensure operators are always working from the latest procedures and make it easier for sites to run twenty-four by seven.”

Direct visibility 

A connected shop floor has the potential to improve productivity and enable better decision-making. Managers track how content is consumed at each facility, station, and device, and update the content on an as-needed basis. This functionality offers a new lens into the effectiveness of the content.

For instance, managers can measure whether document-based instructions are more successful than a short video in engaging workers and improving comprehension. Video is gaining popularity as an effective training tool. Delivering video though mobile devices directly on the shop floor could improve efficiency and compliance. Managers could see how employees are engaging with the content delivered digitally to each station, and, using that data, design instructions and training modules to fit with that particular task or even a particular employee’s learning style.

Centralizing quality event information provides a more complete view and enables greater insights for better decision-making. Data and metrics help identify trends for proactive, and eventually predictive, quality decisions. Teams gain a deeper understanding on how quality events are related, furthering the ability for improving quality and manufacturing operations.

Quality 4.0 and a connected ecosystem

Paper-based process and legacy systems create many business gaps between manufacturing, quality management (QMS), and content management systems, making it challenging to effectively deliver quality products. Innovative life sciences companies are embracing Quality 4.0 technologies to improve operational efficiency and effectiveness and product quality.

Quality 4.0 comes from Industry 4.0 and is usually defined as the adoption of new technology to improve operational efficiency and product quality. Quality 4.0 enables quality systems to integrate seamlessly with complementary systems such as manufacturing execution (MES), enterprise resource planning (ERP), product lifecycle management (PLM), or compliance training systems across the value chain for a more holistic view and seamless execution.

Enabling end-to-end processes helps resolve issues faster. When a MES detects a potential non-conformance, it promptly sends the information to a QMS. The quality team can then quickly evaluate, remediate, or resolve the non-conformance. Connecting a QMS with a MES enables rapid detection, triaging, and remediation of non-conformances.

Connecting operational data allows proactive risk management by addressing quality issues before they arise, as well as provide real-time quality data for analysis to increase productivity and allocate resources based on risk and need. Almost 60 percent of biopharma companies say digital is a top priority and they expect to realize the value of their investments within the next five years. Modern quality management systems also provide transparency for all parties that can drive greater collaboration between employees and suppliers. Information shared with partners helps build alignment and drive progress towards common goals.

With mobile tablets, companies can more easily achieve Quality 4.0 by connecting the shop floor to upstream and downstream systems and all stakeholders.

Modern training techniques 

Quality 4.0 can enable companies to better support modern training methods – providing flexibility and versatility needed in today’s manufacturing environment. Information, such as relevant digital procedures and work instructions, presented to workers on a mobile tablet at specific points in the manufacturing process simplifies complexity and reduces variation.

Passive learning in the form of “read and understand” instructions is gradually being replaced with more engaging content that truly helps employees learn how to do their jobs. 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. This ensures 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. With Quality 4.0 and mobile tablets, learners can access training content at the time of need and according to specific learning styles – changing behaviors 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. 

Connecting the shop floor with mobile devices and cloud-based applications is an example of Quality 4.0 in action. The best Quality 4.0 technologies simplify and speed up manufacturing, while enhancing compliance and quality. 

Greater regulatory compliance

By applying technology that we use in everyday life – mobile devices and intuitive applications – manufacturing operations can become more flexible and aligned to the business. Content delivered to the manufacturing floor via mobile applications remains current, and information is gathered in real-time to support quality and compliance.

A pharmaceutical and medical device company that makes specialty products for civilian and military populations is investing in modern technology to transform processes at all eight manufacturing facilities around the globe for greater speed, compliance, and productivity. Open applications are easily integrated to support continuous, controlled processes – eliminating information duplication and strengthening data integrity. “Mobile tablets will eliminate paper and support more contemporaneous data collection,” according to the senior manager, document control and training, at the U.S.-based company.

Digital processes enable sites to fully align with manufacturing needs and be more responsive to new regulatory requirements. Bringing the shop floor closer to decision makers, cloud applications delivered through mobile tablets enables greater agility and better visibility.  These modern applications are designed for continuous uptime and allow companies to make configuration changes while drastically reducing the validation burden. Making it easier to stay compliant, companies can keep up with regulatory changes and reduce risk.

The future of manufacturing

Legacy systems and paper-based processes cannot easily adapt to manufacture new products or efficiently scale down to produce smaller volume therapies. Quality 4.0 is becoming a reality in life sciences manufacturing as companies adopt solutions to enable agility while improving operational efficiency and product quality. Adopting Quality 4.0 for a connected shop floor, enables manufacturers to gain real-time visibility across content and quality management processes for better tracking and more meaningful and actionable insights. Life science companies can also easily integrate with internal and external systems that track, engage, and facilitate communication and problem-solving in real-time.

Transforming quality management is key to successfully scaling production of new therapies and is ripe with opportunities. Next-generation solutions that emphasize flexibility and efficiency position manufacturers to reap enormous benefits by simplifying and improving quality management. Samsung BioLogics is already seeing a positive impact with their modern approach, reducing product switching time and enabling greater agility as it scales. As companies shift to multi-product lines, they need to become increasingly nimble.

Flexible processes that maintain compliance and integrate technology solutions can support life sciences companies to meet the needs of patients today and into the future. Eliminating siloed systems in favor of streamlined applications allows for greater agility and stronger collaboration while enhancing compliance and end-to-end control. This will help enable life science organizations to meet the new demands of quality management in manufacturing and support innovation in precision medicine.