IDBS Offers Extended Functionality in E-WorkBook Suite Subtracts
1 Jun 2010IDBS announces 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."
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E-WorkBook
IDBSE-WorkBook is driving the revolution in laboratory notebooks and experimental data. The ability to share, search and query experimental data in real time, control access and issue task requests to other team members, allows E-WorkBook™ to offer an organization the opportunity to drive the research process with improved efficiency and enhanced security. Life science organizations invest considerable time and money on protecting IP. Providing a fully searchable repository of electronically-signed knowledge that an organization’s legal department can rapidly access enables faster and more efficient IP protection and exploitation. Drawing on unrivalled ‘real world’ experience of both R&D science and discovery data management, E-WorkBook captures corporate knowledge in a searchable, traceable electronic repository that is validated against 21 CFR part 11 and compilant ready. E-WorkBook provides: • A single research data portal • An easy to use, secure environment that accepts data input from any source • Access to data and knowledge across an organization, irrespective of location • An efficient experiment report-writing tool • A powerful and versatile search engine • Painless implementation of SOP, QA and QC procedures