Quality Technical Services for Enhanced Compliance.
Quality support for all technical matters – Quality Control
Quality Control combines many tools such as inspection, testing, sampling and monitoring to provide high quality data on which decisions regarding the safety, efficacy and performance of medicinal products, medical devices and other life sciences products are made. Arriello can provide support across Quality Control topics through provision of training and consultancy support with data integrity, method development, qualification and validation and review of data and trends. Arriello consultants can provide strategic support but also hands-on support when additional resources are required.
Quality in New Facilities – GMP Facility Design
The construction and qualification of a new facility is a unique experience and at Arriello, we have years of experience supporting our clients with the quality aspects of Facility Design including review of process flows, assessment of GMP compliance, performance of GMP design risk assessments and determination of appropriate airflows for contamination control. With expertise spanning several facility types, including aseptic processing, cell culture and ATMPs, we are well positioned to provide quality and compliance insight at the earliest phases of your facility build where the right decisions are critical to saving cost and delays.
Commissioning, Qualification and Validation
When a new facility is designed and ready for construction, Commissioning, Qualification and Validation (CQV) of the facility and its equipment is the next step to ensure the project remains on budget and schedule. At Arriello we can support all quality aspects of this process including facilitation of System Risk Assessments, review of CQV master plans, assessment of CQAs and review and approval of validation documentation. This phase of any facility construction project requires specific project expertise, ensuring the highest level of compliance throughout the project whilst maintaining a pragmatic approach that is sensitive to the project requirements.
Computerized System Validation
Computerized systems are rapidly developing in the life sciences industry and with increased innovation comes increased validation requirements to demonstrate the compliance of new and complex systems. Arriello can navigate computerized system validation requirements with our clients, maximizing the value of innovation without compromising on compliance.
What our clients say about us.
My experience with Arriello was an overwhelmingly positive one. Very professional, accommodating and readily able to adapt to our needs even as they changed.
Arriello has highly knowledgeable staff in all countries with a very professional attitude. They are very fast in responding when needed.
