QbD Ā» ATMP kick
Advanced Therapy Medicinal Products (ATMPs) offer great new opportunities for the treatment of patients and their diseases or injuries. In ATMP laboratories and cleanrooms all over the world, experts work on the manufacturing andĀ quality controlĀ of these medicines, based on genes, tissues or cells. Efficient management of workflows plays a crucial role in these laboratories and cleanrooms. Thatās why QbD developed QbD Module ā an Electronic Batch Recording (EBR) system specifically designed for ATMPs.
Although the workflow aroundĀ ATMPsĀ is getting more and more complex, many laboratories still use rudimentary tools, like spreadsheets, MS Word and email, to manage the complex workflows during their manufacturing and quality control processes. Often, this results in many practical problems. Employees miss out on e-mails, have problems recalling earlier communication, use outdated document versions or have problems keeping an overview of documents for review or approval. The result? A significant operational impact. You need extra work to keep managing the paper-based system, you need to investigate errors during batch processing due to wrong procedures and ā if worst comes to worst ā whole batches must be scrapped.
QbD Module is a web-based software solution specifically designed for ATMPs. It enables you to manage production workflows and quality control during the ATMP manufacturing process, and to stepwise run batches under regulatory rules. The systemās core features includeĀ the management of patients, facilities, facility locations and cleanrooms. In addition, users are able to create, manage and validate their own specific checklists ā including audit trail ā thanks to a user-friendly point-and-click interface.
With QbD Module, you easily digitise and automate ATMPĀ workflows and are able to work remotely with multiple cleanrooms, hospitals and operators. Other advantages include:
Itās our mission to build the right software applications and user interfaces to support companies in theĀ pharmaceutical,Ā biotechnologyĀ and life sciences industries in their daily activities. We help you to perform complex tasks in a more user-friendly, accurate and faster way. Our software portfolio includesĀ Scilifeā¢Ā QMS, a quality management system in the cloud, and various custom-made validated software solutions.
Receive detailed information fromĀ one of our medical device experts.
Come to see the QbD Group at stand #3G73 at CPHI Conference in Barcelona. And after the conference…Eat & Connect with lifescience professionals at our QbD’s CPHI Networking Drink.