Best Practices for Managing Content in Emerging Biopharma and Regulated Life Sciences Companies

As emerging biopharma and regulated life sciences companies strive to scale operations, content management often becomes an afterthought. However, implementing a robust content management strategy early can avoid inefficiencies, regulatory risks, and escalating costs later.

This blog highlights best practices to help you navigate content management complexities while fostering compliance and operational excellence.

1. Develop a Strategic Content Governance Plan

Early-stage companies often store content haphazardly across email, desktops, and disparate systems. This siloed approach leads to inefficiencies and risks. Establishing a content governance plan ensures centralized access and alignment with organizational goals.

Key Steps:

• Define Ownership: Assign roles for content governance across departments.
• Standardize Processes: Develop workflows for managing, archiving, and disposing of content.
• Centralized Access: Consolidate content into a secure, unified platform.

2. Align Content Strategy with IT and Business Roadmaps

Content strategy must align with your company’s IT roadmap to support growth and commercialization effectively. Emerging companies benefit from integrating content management within their broader IT and compliance frameworks.

Best Practices:

• Incorporate content governance into your IT strategy from the start.
• Plan for scalability to accommodate future growth and regulatory needs.
• Coordinate with stakeholders to align business needs with IT capabilities.

3. Choose the Right Content Management System (CMS)

Emerging life sciences organizations often face the challenge of selecting a CMS that balances functionality, compliance, and cost. Whether it’s an enterprise content management (ECM) system like Veeva or a cloud-based platform like Box or SharePoint, choosing the right system is critical.

Factors to Consider:

• Regulatory Compliance: Ensure the system supports 21 CFR Part 11 and Annex 11 requirements.
• Scalability: Select platforms that accommodate increasing volumes and complexity of content.
• Integration Capabilities: Look for systems that integrate seamlessly with other tools in your tech stack.
• Cost-Effectiveness: For startups, leveraging existing tools like SharePoint Online, included in Microsoft 365 subscriptions, can be a cost-effective interim solution.

4. Prioritize Data Integrity and Security

Regulated industries demand rigorous data security and integrity measures. Protecting intellectual property and ensuring regulatory compliance require advanced tools and structured processes.

Actionable Tips:

• Use platforms with robust audit trails, role-based access controls, and secure eSignatures.
• Regularly review and update data governance policies.
• Validate migration processes to prevent data corruption or loss during system upgrades.

5. Avoid Common Implementation Pitfalls

Poorly planned implementations can lead to failed launches, regulatory risks, and financial losses. Avoid these common mistakes to maximize the value of your content management investment:

• Over-Engineering: Resist the temptation to overly customize your system; prioritize best practices.
• Underestimating Change Management: Engage stakeholders early and invest in end-user training to drive adoption.
• Skipping Validation: Ensure your system’s configurations and workflows meet intended use requirements.

6. Leverage Automation for Efficiency

Automation can transform how your organization manages content. From compliance monitoring to document approval workflows, automation reduces manual effort and improves accuracy.

Key Automation Features to Explore:

• AI-Driven Insights: Use AI to identify patterns and streamline workflows.
• GxP-Compliant Processes: Automate quality and compliance tasks to ensure adherence to regulatory standards.
• Cross-Platform Integration: Connect systems to facilitate seamless data sharing.

7. Plan for Data Migration and System Validation

Migrating content to a new system is a complex process that requires meticulous planning. Proper validation ensures that the system aligns with business needs and regulatory requirements.

Steps to Success:

• Define content types and metadata requirements.
• Use sampling to validate data accuracy and integrity during migration.
• Document configurations to align with validation protocols.

8. Monitor and Adapt Post-Implementation

Content management doesn’t end after implementation. Continuous monitoring and iterative improvements are necessary to maintain compliance and operational efficiency.

Post-Go-Live Best Practices:

• Establish a process for managing vendor-imposed changes.
• Conduct regular audits to ensure alignment with evolving regulatory requirements.
• Gather user feedback to refine workflows and enhance usability.

The USDM Advantage

USDM Life Sciences specializes in helping life sciences companies implement and optimize content management solutions. Our expertise ensures that you avoid common pitfalls while leveraging the latest tools and technologies to achieve compliance and operational excellence.

Ready to unlock the full potential of your content management system? Contact us today to learn how we can help you build a robust, scalable strategy tailored to your business needs.