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."