Mark O’Donnell, President & PartnerGlobalization coupled with stringent regulatory requirements is creating challenges in the pharmaceutical and life sciences industry. These drivers are forcing companies to re-examine their approach towards compliance for creating a competitive business advantage. Headquartered in Willow Grove, PA, Azzur Group is a consulting service provider, offering a variety of compliance services to the life sciences sector. The company also offers project resources within the quality assurance, laboratory, clinical, IT/IM, business processes, manufacturing, operations, and R&D settings to pharmaceutical, biotechnology, and medical device clients.
Azzur Group’s in-depth consulting expertise in all facets of the system life cycle assists clients throughout the different phases to reach their goal of running a lean but efficient operation. The experienced staff can help with requirements definition, vendor selection, configuration, implementation, testing and validation, and maintenance. In the life sciences sector, numerous medical equipments are dealing with mission critical and life sustaining situations where timely service and downtime monitoring could even save a life. The Azzur Equipment Tracker is a powerful way to organize equipment data using Quick Response (QR) codes and a mobile device. Utilization of QR Code technology allows quick and easy access to important equipment information such as maintenance, calibration, and validation information on any mobile device equipped with a camera and a QR code scanner application.
The tracker allows the user to attach equipment manuals, calibration certificates, maintenance records, procedures, photos, and validation documentation for quick and easy access via web, mobile phone or tablet computer while in the field when it is needed the most. There is no longer a need for long documentation searches as the product gives instant access. Azzur recommends RedLaser for iPhone, iPad, Android and Windows devices and QR Code Scanner Pro for Blackberry devices. Security is important to Azzur, and hence HTTPS encryption is used which ensures safe data. An email notification on maintenance, calibration, and revalidation is sent to the equipment owner upon the due date.
Azzur strives to develop an intimate partnership with clients to remain a pre-eminent provider of systems regulatory compliance and quality assurance services to the worldwide pharmaceutical, biotechnology and medical device industries.
Utilization of QR Code technology allows quick and easy access to important equipment information such as maintenance, calibration and validation information on any mobile device equipped with a camera and a QR code scanner application
The testimonial from one of their clients, Medimmune, sums up the Azzur expertise. “Azzur has provided quality validation services for our group for many years. They have high technical expertise, work independently and employ validation principles in all their work. They can seamlessly transition from commissioning activities to validation and interact well with other user groups during qualification of their equipment,” says Diana Graves, QA Advisor, Medimmune.
The primary services of the company encompass commissioning and start-up, design, installation, operational and performance qualification, process, and cleaning validation. Azzure also addresses all areas of FDA regulations and compliance issues. Validation, Inc. (an Azzur Group Company) offers professional commissioning and qualification services to the life sciences industry. It has experience with risk-based approaches such as ASTM E2500—standard guide for specification, design, and verification of pharmaceutical and biopharmaceutical manufacturing systems and equipment to deliver projects on time and under budget without sacrificing quality.
On the company’s journey ahead, Azzur Group envisions to provide computer systems implementation, validation and quality assurance services that facilitate bringing new and enhanced products, processes and technologies to both providers and consumers.