Drug discovery and development firm deploys solutions for current goods manufacturing practice compliance
Redwood Shores, CA — December 7, 2004 — Albany Molecular Research Inc., a chemistry-based drug discovery and development company, said it has successfully validated and gone live with the document management capabilities of MetricStream's quality and compliance suite to reduce the cost of current goods manufacturing practice (cGMP) compliance associated with managing regulatory documents within its environment.
Albany Molecular is currently deploying the MetricStream Corrective Action and Preventive Action (CAPA) and Out of Specification (OOS)/Variance modules as a part of their second phase of the implementation.
Albany Molecular is a leading research, drug discovery, development and manufacturing company built on a chemistry platform of comprehensive and integrated technologies, resources and capabilities. The company conducts research and development with many leading pharmaceutical and biotechnology companies and for its own internal discovery programs, and provides cGMP manufacturing of active pharmaceutical ingredients through its wholly owned subsidiary, Organichem Corp.
According to Ashley Peacock, validation manager at Albany Molecular, the MetricStream professional services organization enabled the company to go live with the solution in a very smooth manner. "We are very happy with our choice of MetricStream and look forward to going live with their CAPA and OOS applications to continue to automate our cGMP processes and significantly improve our operational efficiency," she said.
"We are very excited to see Albany Molecular managing a key aspect of their regulatory environment using our solution," commented Shellye Archambeau, CEO of MetricStream. "The MetricStream suite is designed to streamline and manage the cGMP processes and it continues to be the solution of choice among leading [Food and Drug Administration (FDA)] regulated organizations within the United States."