Court Square Group Unveils Quality and Audit Services.

SPRINGFIELD, Mass. -- Court Square Group, Inc., a professional consulting firm specializing in strategic information technology and project management, announced today that the Quality and Compliance group within its Life Sciences Practice is ready to deliver a wide array of services to biotech and pharmaceutical companies..

"During the past year, Court Square has expanded beyond its traditional managed services and project management offerings to include a full suite of audit and compliance services," said Keith Parent, CEO of Court Square Group.

"Today, our clients span a broad range of disciplines and industry segments, including pharmaceuticals, biotechnology, contract research, medical devices and more. And their business and regulatory challenges go well beyond mere Part 11 compliance." They need a complete suite of audit and compliance services, and we intend to deliver them," said Christopher Port, Senior Vice President of the Life Sciences Practice.

Court Square has provided software validation and hardware qualification services to the life sciences industry for many years. The new audit and compliance services extend this knowledge to software quality assurance audits, IT service provider and application vendor audits, infrastructure audits, and more. The highlight of the new services is a complete audit management service of GMP, GLP and GCP requirements.

"Too many life sciences companies take a reactive approach to compliance, which leads to an endless cycle of remediation projects and lost productivity," said Kathleen Pelley, Director of the Quality and Compliance Group at Court Square. "Our proactive audit and compliance services identify business process and technology issues before the FDA inspectors arrive, and rectify these problems by recommending improved management processes or better IT infrastructure. Most clients find that sound auditing services pay for themselves in a very short period of time. In addition, our audit management services eliminate the confusion that results from multiple audit companies using disparate approaches and reporting methodologies. "

Infrastructure audits are another way to ensure compliance and improve productivity. Court Square's years of experience in managing data centers, networks and other infrastructure for leading life sciences companies gives the company great insight into how risk-based analysis can be used to streamline operations while never failing an FDA inspection.

"Many life sciences companies simply don't know which systems are likely to be inspected by FDA or how deeply," said Pelley. "In fact, all IT systems should be audited, but risk-based analysis helps you determine which ones need the most attention. Many companies waste time and money because they fail to understand this process. Our highly-trained auditors know which systems need more attention than others."