Sharp plays a key role in the biotechnology and pharmaceutical industries by providing contract packaging and clinical trial supply services. Through their partnership with Berkshire Sterile Manufacturing, they offer isolator-based filling of vials, syringes, cartridges, and containers as well as lyophilization and terminal sterilization. From Phase I clinical trials to commercialization, their expertise in innovative technical solutions from research and development through to commercial packaging has positioned them well to manufacture and package in multiple formats to deliver quality products.
Sharp is closely involved in the clinical trial process where studies require secondary packaging processes to anonymize and test Investigational Medicinal Products (IMP). Understanding that clinical trials can cost tens or even hundreds of millions of dollars and up to a decade to complete, Sharp aims to enhance the quality and efficiency of its operations to reduce the time, cost, and complexity of clinical trials. Sharp’s vision led them to collaborate with Tulip whose no-code platform offers a range of benefits:
- Freedom to generate apps on a qualified platform to digitize operations, strengthen compliance and improve business efficiency
- Implementing new technology with a short learning curve
- Real-time verification to validate that their packaging contains the correct components
The secondary packaging process for IMP was a highly involved process prior to implementing Tulip. Production associates assembled and labeled the packages, while others verified and documented the completion of each step. In order to continuously improve their processes, Sharp worked with Tulip to digitize their workflows, gain visibility over their operations, quickly ramp up their new employees, and improve quality.
Sharp collaborated with Tulip and its development and implementation partner Sequence to explore the use of a cloud-based frontline operations platform, powered by Amazon Web Services, in the secondary packaging process for IMP. One of the first applications Sharp pushed onto their frontline operations was a guided work instructions app. Production associates would follow visual content with text, pictures and video displayed at each station to assemble, capture images or videos during the packaging and labeling process, and document to maintain GxP compliance. This allows production associates to quickly shift from assembling to labeling and completing each step correctly with guided work instructions to validate each step.
When packages are labeled, operators follow another guided work instructions app for quality inspection. These operators scan the barcodes to provide digital verification and automatically save the information for audit purposes.
Digital work instructions log every action and generate reports to monitor the packaging in real-time. This forms a digital audit trail that provides traceability where errors can be tracked through Tulip to ensure quality and give insights on the most common errors to the quality control team.
In recent times, the quality control process has been under more frequent and thorough reviews by the FDA to ensure practices are compliant with regulatory requirements. The Tulip platform’s ability to safeguard processes and create electronic records enables Sharp to easily verify technology on the production floor and reduce the burden of compliance.
Automation resulted in a 30% faster clinical trial packaging process over the manual process before Tulip. By having the IMP available for distribution sooner, Sharp can reduce the friction in running clinical trials.
After implementing guided work instructions, real-time dashboards, and replacing written quality reports, Sharp experienced improvements in quality, efficient training, and gained insights from real-time data on dashboards. Disruption was minimal and the team was on the path to getting a quick return on investment. Tulip’s no-code capabilities made building applications in-house simple. Configurable apps gave Sharp the flexibility to create their own solutions that naturally fit their processes.
Now that Sharp has full visibility into its operations, the team can efficiently customize its packaging process to each individual client’s needs. With Tulip, they can use digitized quality reports to reduce the burden of compliance and Sharp can scale its packaging services to deliver flexible and more efficient clinical services.
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