Azzur IT
Helping Regulated Life-Sciences Companies Navigate IT Quality & Compliance

The regulated pharmaceutical, biotech and medical device industry is continuously evolving, especially within a rapidly changing IT landscape. As legacy systems are being replaced with their updated equivalents, companies are often being presented with unanticipated risks. Moreover, the requirement to stay in compliance with regulations often causes dilemmas for IT organizations, in particular the narrowing space for companies to adapt and cope with technology change. This has increased demand for effective solutions as well as professional services that help companies stay aligned with the regulations, while achieving operational excellence. Azzur IT is a firm that provides professional services to the regulated lifesciences industry, steering their customers through a myriad of compliance challenges while ensuring robust, efficient technology implementation and maintenance.

Azzur IT is an Azzur Group company providing a broad range of services, including IT quality and compliance; computer systems validation (CSV); application selection, implementation, integration and project management services; network infrastructure, IT operations and data center assessment; SOx consulting and risk analysis, process improvement and quality auditing. The company’s “partnership is power” strategy plays into their ability to assist clients in implementing, maintaining, and retiring applications within a risk-scaled, compliant framework. “Whatever the need be, our IT compliance services are designed to take our customers through the process. It’s what we call ‘Discovery to Delivery’,” says Ryan Ott, Managing Partner at Azzur IT.

Azzur IT’s in-depth professional services span the full range of system development life cycle (SDLC) management, focusing on practical solutions that meet their client’s scope of need, while maintaining compliance, data integrity, and change management throughout the entire lifespan. “Not only is robust, userfriendly functionality important, but there has been a steadily increasing emphasis on control over raw data going into business and regulatory decision-making.

Data maintenance, integrity, change history, chainof- custody, back-up/ recovery, and overall accessibility for review by stakeholders and regulators, are key factors needed to be considered when adopting new technology,” says Ott. For Instance, the company helps its clients map the data pathway from creation to storage, and understand and implement the necessary controls. In an era of outsourced IT infrastructure and software-as-a-service (SaaS), and the ever-increasing rate of cloud-solution adoption, companies are continually exploring optimized technology that supports their compliance requirements. As such, Azzur IT subject matter experts are often partnering with their clients to ensure the appropriate due-diligence audits and quality agreements are applied as important pieces of the Cloud-compliance landscape.

Azzur IT focuses on SDLC support within the quality assurance, laboratory, clinical, IT/IM, business processes, manufacturing, operations, and R&D settings of their pharmaceutical, biotech, and medical device clients. “We deliver solutions that balance business with compliance, delivering final project outcomes scaled to meet the business needs and financial considerations of the company,” adds Doug Shaw, Director of IT/CSV for Azzur IT. Moreover, Azzur Group delves into risk assessments as it helps their clients hone the critical factors influencing the success of both new implementations, as well as proper maintenance of existing systems. “Establishing risk profiles helps them lay out an efficient plan to validate systems initially, and maintain the controlled state of their system all the way through to retirement. Beyond that, companies need to ensure they have the necessary framework in place to bring new systems into compliance as they come online,” says Shaw.

Moving forward, Azzur IT envisages growing and enhancing its IT services footprint within the life sciences arena. “We will stay focused on providing expanded services, not only from the compliance perspective, but also in staffing and targeted technical solutions,” concludes Ott.