Extended Functionality in E-WorkBook Suite Subtracts Weeks from Validation of QA and Regulatory Reports
Guildford, UK, and Burlington, Mass., June 2, 2010 – IDBS, the leading worldwide provider of research data management and analytics solutions to R&D organizations, today announced innovative new one-click Microsoft® Word publishing functionality in its E-WorkBook Suite. One-click publishing capabilities enable rapid generation of complex reports, particularly those requiring regulatory compliance, including investigational new drug (IND) reports, new drug applications (NDAs), biologics license applications (BLAs), study reports, and validation reports.
Traditionally, validation teams have spent several weeks checking through many complex reports, diverse databases and paper binders in order to authenticate the information required for regulated reporting. This important new function in E-WorkBook Suite enables the process to be completed in a matter of hours.
E-WorkBook’s configurable Microsoft Word templates enable scientists and regulatory groups to instantly integrate and present all supporting experimental results – including tables, text, images and metadata – in the precise format and styles required for internal or external reporting. E-WorkBook reports also include hyperlinks to all underlying E-WorkBook records, which enable QA teams to rapidly validate the originating data, saving considerable time, effort and cost.
“Creating and validating regulatory documents is a massive, time-intensive process that requires data, communication and collaboration from numerous departments that don’t usually talk to each other,” said Ruchi Mallya, analyst, Pharmaceutical Technology, Ovum. “There is a huge need for a data management solution that simplifies and streamlines the report generation process, while retaining the utmost data integrity. The industry needs this type of approach to save money and time, not to mention to reduce risk.”
“E-WorkBook’s one-click reporting capability expands the scope of what a high-value ELN should deliver,” said Neil Kipling, founder and CEO of IDBS. “Our focus on data management and on what the customer really needs has enabled us to deliver a sophisticated solution that meets complex and challenging reporting requirements, even in the regulated environment.”
IDBS is a unique, global supplier of innovative data management and analytics solutions, which increase efficiency, reduce costs and improve business and scientific productivity of R&D organizations worldwide. Organizations such as Pfizer, GSK, Celera, MedImmune, Dana-Farber, and Roche employ IDBS solutions as an integral part of their strategy to address the increasing pressures placed upon them by the need for the secure, compliant capture, integration and analysis of complex research data. IDBS is clearly differentiated from other software providers by its unique combination of deep domain knowledge and its ability to rapidly provide integrated business process and robust data analytics solutions along the entire R&D value chain. IDBS solutions secure organizations’ valuable R&D data assets and enable rapid decision-making through effective integration and analysis. They also support the protection of Intellectual Property (IP) and the requirements for data quality demanded under Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) standards.
IDBS is a private company, founded in 1989 and headquartered in Guildford, UK. IDBS has worldwide consulting and support presence, with U.S. offices in California, New Jersey and Massachusetts, the EU, Australia and China.