The coalition of the compliant

Open Text has added two new members to the Livelink family.

Livelink for Corporate Governance is engineered as a central place to document and manage corporate risks and internal controls, organize project teams and help improve compliance with corporate governance laws. Livelink for Collaborative Submissions gives life sciences companies a single, unified environment for managing the complex process of assembling, approving, releasing and archiving new drug and medical device applications required to enable human clinical trials and product marketing.

Open Text explains that the new features for Livelink for Corporate Governance include an XML-based bulk import loader, which uploads internal controls information from a variety of databases into Livelink workspaces. The new capability was developed as part of Open Text’s own efforts to comply with Sarbanes-Oxley. The company reports it engaged Deloitte to assist it with Sarbanes-Oxley compliance and used portions of Deloitte’s industry-specific internal controls database, Risk and Controls Knowledgebase (RACK). To improve its ability to manage its internal controls information, Open Text developed a bulk import capability that works with RACK.

Livelink for Collaborative Submissions offers a single, end-to-end system to manage eCTD-compliant submissions to the U.S. Food and Drug Administration (FDA), the European Medicines Evaluation Agency (EMEA) and other regulators worldwide, says Open Text. The company adds that the solution combines document, forms and records management software, content publishing tools and the ability to automate a wide range of processes, from ad hoc to tightly sequenced workflows. Integrated tools such as check-in/out, version history, event auditing, signing controls, alternate renditions and compound documents make it easy to manage documents, their constituent documents and related components to ensure accuracy, says the company.