Content Management for Regulated Industries

Life science businesses, such as those in the pharmaceutical, biotech, and cosmetic sectors, now operate in an increasingly regulated environment. At both federal and international level, regulations are placing ever more complex demands on CIOs who are already battling to ensure their systems are as robust as possible in order to facilitate an accelerated time-to-market.

The need to manage documents in compliance with FDA 21 CFR Part 11 and EU Annex 11 regulations adds to the pressures already facing businesses looking to maintain all controlled documents in an orderly fashion. At the same time, huge quantities of information stored on legacy systems also need to be made available to all stakeholders.

Thankfully, with TerraLink’s solution it is easier than ever to manage and control key documents throughout their lifecycles via features including electronic signatures, approval workflows, metadata management, and version control.

The diagram above shows the seven questions that need to be answered to use hidden knowledge. We should know where to find the information sources, understand the information we gather, and know how to structure and store it. Finally, we need to know how to share and actualize knowledge, and how we can find it in future.

TerraLink’s content management for regulated industries solution provides world-class control for life science companies. By installing a single, highly scalable content repository businesses become instantly capable of effectively managing millions of documents – including text, spreadsheets and drawings.

The nine-level permission model – including controls such as See, Modify, Edit Attributes, Reserve, and Delete – allows you to maintain ultimate security, enabling only appropriate users to conduct actions at a level representing their seniority within the business. Extensive version control features, including change histories and audit trails that reveal when, what and why changes were made to documents, further strengthen your position.

• One client reduced its document approval processing costs by 60% in one year.
• Another saw increased productivity by reducing manual document processing time by 66%.
• And another achieved 100% regulatory compliance using the content management for regulated industries solution.

TerraLink’s content management for regulated industries solution offers integration with leading point solutions, such as eSubmissions, eTMF, QMS, LIMS, LMS, and PV, as well as with ERP and SharePoint. It provides an environment in which life science business can securely create, process and dispose of documents, with role-based viewing and printing reinforcing its inherent security.

Configurable workflows reduce the initial validation effort and remove the need for additional re-validation if and when workflows change. And by enabling businesses to easily comply with regulations and maintain auditability, the threat of warning letters and plant shutdowns is reduced.

TerraLink’s content management for regulated industries solution can also:

• Enhance competitive advantage and accelerate time to market by providing an efficient system in which documents are managed and automatically comply with FDA 21 CFR Part 11 and EU Annex 11.
• Increase productivity and efficiency by providing a single repository for securely organizing, controlling, and sharing enterprise content.
• Minimize change management and training costs by providing access to regulated content via familiar desktop applications.
• Create business value and achieve strategic success with an intuitive workflow designed to provide security, control and appropriate accessibility for all content throughout its entire lifecycle.