From Bench to Bedside to Benefit

From constantly evolving technologies to highly complicated supply chains, advanced therapy manufacturing comes with its unique set of quality challenges:

• Comprehensive GMP Documentation
• Complicated Supply Chains
• Rigorous Training Requirements
• Multiple Site Audits
• Extensive Risk Assessment

As you move from basic therapy research to the clinic, and later on to commercialization, it is vital you ensure process consistency, product quality and proper documentation throughout the manufacturing process.

However, relying on a paper-based quality management system only makes compliance harder.

That’s why you need a modern QMS system that helps you ensure quality, consistency and reliability through every step from patient sample collection, to transportation, to manufacturing all the way back to the patient.

Developing advanced therapies means dealing with sophisticated logistics, strict time restraints, material variability and cold chain management of sensitive material. A solid QMS is needed to evaluate each element of the supply chain through operational, quality and compliance perspectives.

The Supplier Management module from ComplianceQuest helps you better manage your supply chain so you can stay on top of time-sensitive and temperature-critical logistics with digital supply chain management. You will also be able to collaborate in real-time with everyone involved in the supply chain with the Supplier Portal, to make sure patients are getting their therapies on time.

Catching and addressing quality issues is vital in guaranteeing product quality and patient safety, especially for advanced therapies where product lifecycles are short and time is of the essence. Paper-based systems are not agile by design and stand in the way of proper quality control and quality assurance.

ComplianceQuest provides CAPA, non-conformance, laboratory issues and complaint management solutions to take your Quality Control efforts to the next level. The connected suites allow you to leverage CAPAs to drive continuous improvement of your processes and improve QC with faster identification and resolution of quality issues.