CS Analytical Laboratory, the world’s only cGMP, FDA-registered and inspected contract laboratory exclusively designed and dedicated to container testing for the pharmaceutical, biotechnology, and medical device industries, is pleased to announce the creation of a new internal team specifically designed to support all aspects of its computer and electronic based quality and laboratory operation systems. The two key hires, Khalid Hassan, a Computer System Validation expert and Michael Mongelli, a Software Systems Engineer, will oversee and manage the entire hardware and software platforms currently in place and will have dual reporting responsibilities to the Director of Quality and the Chief Scientific Officer.

“In today’s regulatory environment, it has become the norm that services are provided and documented in a secure electronic format. 21 CFR Part 11 compliance may be the most important aspect of any modern-day quality system. Building a dedicated internal team to support the CS Analytical platforms is the logically approach and one that will enable us to differentiate ourselves from our competitors,” commented CS Analytical CEO Brian Mulhall.

CS Analytical has made extensive investments in both the hardware and software requirements that enable the operations to function is a Part 11 compliant environment. The platform includes an electronic document management system, electronic laboratory notebook and a custom designed Laboratory Information Management System (LIMS). In addition, the laboratory has been designed to enable all critical instrument systems to be digitally networked to create a holistic system that operates in a secure and efficient manner. The regulatory requirements around Part 11 compliance are critical. Dedicating an employee team of experts who understand the unique requirements of validating an extensive FDA regulated computer system network and having software engineers onsite to address issues real time is becoming the new and required expectation.

Khalid brings many years of project work specific to instrument and laboratory computer system validation. He has first-hand experience in defining user requirement specifications, drafting network architecture charts, and writing validation protocols and reports across a wide array of instruments and managing the execution of these unique protocols.

Michael is a software engineer with a degree in computer science. With mastery of various computer languages, he has the ability to develop and integrate software systems across different languages and platforms. His experience and knowledge will ensure that our software systems are in a continuous state of improvement to meet business demands and the high expectations of both clients and regulators.