Breaking down information silos

A shared, single source of regulated content for Life Sciences

Introd-uction

The expiration of patents intensifies competition in the Life Sciences industry. Companies aim to accelerate the introduction of new medications by utilizing strategies such as embracing novel business models, extending their global reach, establishing partnerships, and engaging in acquisitions. These approaches are executed amidst evolving regulations, the necessity to reduce expenses, and enhance operational efficiency across the drug lifecycle.

Mergers and acquisitions frequently lead to disparate systems with personalized applications, impeding data exchange and teamwork. Striking this equilibrium poses a challenge for IT, affecting their adaptability in adapting to business shifts while consuming a substantial portion of the IT budget.

Documentation

The common thread

To efficiently and cost-effectively introduce safe, high-quality products to the market, it is vital to streamline processes that involve various areas, departments, and external collaborations. Moving a drug or device from research and development to the market requires ensuring its safety, effectiveness, and compliance with GxP standards.

A key challenge is maintaining thorough, precise, and tightly controlled documentation throughout the product's life cycle. It is essential to have seamless sharing and connectivity of documentation across all stages, including discovery, regulatory approval, and commercial production, to ensure compliance, enhance efficiency, and boost worker productivity. Despite the availability of diverse tools and processes for analyzing, interpreting, and sharing information, what is often missing is a unified effort throughout the organization, supported by an integrated content management system.

Unified solution layer

Life Sciences companies should aim for a solution that provides a centralized location for regulated content across the extended enterprise. Having a single content source helps prevent disruptions in processes when moving between different areas.

Technologically, this "unified solution layer" is built on a shared enterprise information structure with standardized inventory and data models. This setup enables IT teams to implement various solution modules in a unified repository. Users can perform searches and connections across domains, ensuring they always find the most current and relevant content.

This approach significantly simplifies user interaction, offering essential traceability to source documents and proactive alerts to relevant parties in the event of document changes. Instead of managing multiple logins and transferring documents between applications, users can log in once with a single account to access authorized content based on their role and permissions.

Seamlessly linking content

example 1

Between clinical and regulatory

Several documents, such as protocols, clinical study reports, and informed consent forms, are essential in both the electronic Trial Master File (eTMF) for audits and regulatory marketing applications during submissions.

• Many organizations encounter challenges with version control, traceability, and manual processes when transferring these documents between systems.
• Some companies resort to costly custom integrations to facilitate document sharing between the eTMF and R&D systems.
• Conversely, a unified solution layer seamlessly connects the current approved document version from the clinical system directly to the R&D solution.
• This integration enables clinical and regulatory staff to access the same source document, resolving version-control issues.
• In case of any modifications to the source document, proactive notifications can be sent out to all involved parties.

example 2

Between regulatory and quality

When scaling up and transferring knowledge, various documents used in regulatory submissions need to be transitioned to the realm of commercial production. Once these documents move to production manufacturing, they must adhere to good manufacturing practices (GMP) standards.

Research and development (R&D) and quality and manufacturing (Q&M) documents are typically overseen by separate groups using different systems or repositories due to their distinct lifecycles, security needs, and controls. However, after the transfer from R&D to manufacturing, key stakeholders on both ends often lose visibility.

This lack of visibility poses a significant compliance risk if resubmission becomes necessary without proper communication or action. The absence of automated traceability or notifications during the transfer of copies between systems can result in errors, document mismatches, and compliance issues. Implementing a unified solution layer facilitates the smooth transfer of content from R&D to the commercial manufacturing domain.

Driving efficiency, productivity, and reduced cost

The fundamental principle is unity. In the IT domain, streamlining configurations for document lifecycles and workflow types can notably shorten development schedules. This method enables staff to create content once and uniformly apply it across different business sectors. By cutting down on testing through single validation rather than testing in each solution, deployment becomes faster, with streamlined updates and troubleshooting in the future.

Sharing property registrations guarantees consistency across solutions, maintaining uniform data values like drug details (name, dosage, form) throughout the organization to support data governance. Additionally, merging configurations eliminates compliance discrepancies between solution modules, facilitating adherence to corporate quality management protocols.

Simplified deployment, reduced testing, and simplified maintenance lead to cost savings, reduced strain on IT resources, and improved responsiveness to business needs.

Simplifying and enhancing the user experience

While the advantages are clear for IT, the benefits for business users are just as prominent. In the current environment, users are tech-savvy and expect a modern, user-friendly experience in a professional setting that requires minimal training.

The unified solution layer offers users convenient access to essential applications, simplifying their work tasks in an intuitive way. Whether they are creating a clinical study report, searching for approved content, or reviewing standard operating procedures, users can effortlessly complete these tasks on-site or on the go using a tablet.

Throughout the drug lifecycle, business users can swiftly find approved document versions, refer back to source materials when necessary, and collaborate across teams for impact analyses in response to regulatory changes or other modifications.

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VILT is a company specialized in information management, process optimization, and customer experience improvement (internal/external). We help companies become more operationally efficient through the adoption of digital solutions, full data integration, and advanced analytics.

With a +20-year partnership with OpenText, VILT's deep experience and expertise are recognized globally, with a client portfolio of over 400 organizations worldwide.

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