TransAccel Group – regulatory operations

Banish the Frankensystem Monster: Content Management Across the Lifecycle

By Mark Lane|July 19th, 2017|Categories: Information Management|Tags: collaboration, commercialization, compliance, component authoring, content creation, content management, controlled content, document management, documentation, frankensystem, information management, life sciences, localization, pharmaceutical, regulatory, regulatory information management, regulatory operations, RIM, version control|Comments Off on Banish the Frankensystem Monster: Content Management Across the Lifecycle

In previous posts, we discussed the ever increasing evolving challenges of information management in Life Sciences, and how the “Frankensystems” we use today create confusion, inefficiency and higher costs.

If you want to banish the “Frankensystems” in your environment, there are three key things you need to do:

Select the right tool
Create efficient business processes
Develop a robust change management plan

A better mousetrap

Most tools do not address the entire lifecycle. In the figure shown, the outer ring represents the lifecycle from finding the right content to publishing and distributing the final product, and the inner circles illustrate the tools or systems that are used typically.

To manage information today, various systems are used at each step, and often (in the case of email) information or documents are handled outside the system.

Fortunately, there is now a single, end-to-end, system that includes the necessary functionality and integration for managing information in the lifecycle.

Docuvera, a cloud-based software offered by Author-It, is a unique solution that supports creation, review, approval, localization, storage and distribution of your key regulated and controlled information and documents within a single integrated system. A component-based authoring solution, Docuvera enables information reuse and ensures consistency and accuracy across documents. Content is created once and can be re-used across document types or global regions. Changes are made once and are automatically replicated throughout the document library. Provided with a clear audit trail, version control issues are eliminated. The ability to reuse content across departmental silos improves visibility and transparency while increasing efficiency and reducing costs. Some clients have avoided or reduced cost by 29-44% for document creation, and 74% for reusing information. It helps you work faster too: reducing cycle time by as much as 40-45%.

Setting up for success

Too often companies assume that a new technology or tool will fix their pain points. But without efficient business processes and effective change management, most (70%) technology implementations fail. Docuvera—or any solution—alone will not banish the monster. It needs to be supported by efficient business processes and effective change management and communication.

TransAccel Group is uniquely positioned to help design, execute and realize the benefits of an integrated, enterprise-level information management strategy. Our approach …
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Do you manage documents using a modern-day Frankensystem?

The way we create, review, localize, store and manage documents in the pharmaceutical industry today bears a striking resemblance to the story of Frankenstein’s monster (at least in the original film version). Several tools, systems and processes are cobbled together to manage the high volume of documentation needed to support drug development and commercialization, without much planning, testing or feedback.

How did we get here?

Like many sectors, the pharmaceutical industry is known for functional siloes, which make it difficult to communicate and collaborate across the enterprise. The challenges are magnified when multiple systems are involved, and further compounded when information needs to be shared, or when larger documents, such as submissions, need to be created collaboratively across business functions.

It starts with scattered information and broken processes.  

When you’re creating a document that cuts across functional areas, such as a regulatory submission, medical writers, subject matter experts and/or authors must spend time identifying and retrieving content, by searching across multiple systems (drives, folders, other storage systems) and emailing various contributors to find the most up-to-date content. When more than one author is involved, people must either work independently on their sections, or documents must be checked in and out, making collaboration more complex.

The evolution of Frankensystems

Identifying content, creating documents, reviewing and localizing documents is challenging enough without complicating matters further by using multiple systems. But this approach started because an integrated solution wasn’t there to support the end-to-end process, so companies addressed each sub-process as technology became available. Today, “Frankensystems” persist and multiply in the absence of an integrated strategy that brings together business and IT goals, and manages information, documents and the supporting processes.

Can you banish the monster—or at least teach it to dance?

Yes! The …
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