Acceleron Selects QUMAS to Manage Regulatory Documents
Cork, Ireland — August 30, 2012 — QUMAS today announced that Acceleron Pharma Inc. has selected the QUMAS DocCompliance™ to manage all of its regulatory documents following an extensive vendor evaluation process.
Acceleron is a biopharmaceutical company developing protein therapeutics for cancer and orphan diseases.
Initially, QUMAS DocCompliance™ will be deployed in the Research and Development group and will provide users with a secure, structured, and controlled environment in the Cloud for the creation, approval, and management of documents from all areas of the organization that have an impact on regulatory submissions, including electronic common technical documents (eCTDs).
"Acceleron chose QUMAS for a number of reasons," said Suada Celikovic, Regulatory Affairs Specialist with Acceleron. "QUMAS provides a high level of software functionality and a commitment to customer support. QUMAS had strong industry experience in validation that we required, backed up by an excellent local track record. From start to finish, DocCompliance has been straightforward to deploy and manage."
"We are very pleased that Acceleron Pharma has chosen our software for their regulatory compliance requirements, and particularly that they will be using the solution in the Cloud", said Kevin O'Leary, CEO for QUMAS, "Being a leading biotechnology company, they are another prestige addition to our fast growing client base. We are looking forward to working closely with them to leverage the depth of functionality that only QUMAS has to offer."
Acceleron is a privately-held biopharmaceutical company committed to discover, develop, manufacture and commercialize novel protein therapeutics for orphan diseases and cancer. Acceleron's scientific approach takes advantage of its unique insight to discover first-in-class therapies based on the TGF-β protein superfamily.
QUMAS is the leader in Compliance and Quality Management Solutions for the Life Sciences industry, with more than 260 global customer deployments and domain expertise in regulatory compliance since 1994.
QUMAS Quality Management solutions provide Electronic Document Management (SOPs, QA documents), Electronic Process Management (CAPA, Deviation, Change Control, Audit), and GMP Compliance Management. QUMAS Regulatory Affairs solutions provide content and Submission Management including eCTD authoring templates, collaborative review, full integration with leading publishing solutions, scanning, and automated import of paper documents.