Document Management Best Practices

Part 2 - Draft Management, Reviews, and Approvals

Part 1 of the Document Management Best Practices series provided guidance on managing foundational elements like templates, document hierarchy, language, and revision frequency. Now, let’s take the next step in our journey by diving into document lifecycles, specifically focusing on draft management, document review, and approvals.

1. Draft Management: Avoiding the "Document Draft Graveyard"

Drafts are documents that are not yet approved or effective for use. Whether they’re new documents being created or revisions of existing ones, managing them well is crucial. Without a process, drafts can accumulate and lead to compliance risks and confusion. I had encountered a midsized biotech with 1,500 drafts—nearly 20% of their total documents. Most turned out to be duplicates or irrelevant, cluttering their system and leading to confusion.

Best Practices for Managing Drafts:

• Map the process via a flowchart. This helps authors understand where to begin and ensures the full scope is captured.
• Establish a clear process for managing drafts. Define how drafts should move through the process or be archived or removed. Allow authors to archive or remove drafts to reduce the workload on Document Control.
• Regularly review drafts for activity. Run quarterly reports to identify aged drafts without recent updates and notify authors before archival or removal.
• Watch for duplicate content. This will help you eliminate unnecessary drafts, increase compliance, and ensure clarity.

By implementing these practices, you’ll keep drafts from piling up and turning into a "Document Draft Graveyard," where documents linger without purpose.

2. Streamlining Document Reviews

Document review is essential to ensure that content is accurate, fit for purpose, and compliant. However, challenges arise when there’s uncertainty about who should participate, or when too many people are involved. One mid-sized biotech I worked with had a document stuck in an endless feedback loop—it was on its 45th revision and still hadn’t been approved, leading to inefficiency and delay.

Best Practices for Document Reviews:

• Define reviewer roles and responsibilities. Use a simple matrix to clarify who needs to review each document type and what they should focus on.
• Time the involvement of QA and Document Control carefully. Including them too early can lead to reviewing content that’s not finalized. Monitor the process and adjust as necessary.
• Use tools like "track changes." This helps reviewers quickly identify modifications.
• Ensure the right people and the right number of people are involved. Approvers should have a chance to review documents before they reach the approval stage. Selecting an appropriate number of reviewers will lead to more complete assessments and reduced lead times.

Following these practices helps prevent endless revisions, speeds up the process, and ensures the right feedback is captured.

3. Effective Document Approval: Simplifying Compliance

Document approval verifies that a document is adequate before being issued for use. Like reviews, approval can face issues like having too many approvers or even authors approving their own work. I’ve seen situations where subpar documents were resubmitted repeatedly until approvers, worn down and feeling like maybe they are nitpicking, finally approved them—an approach that poses significant compliance risks.

Best Practices for Document Approvals:

• Clarify approval roles. Avoid including unnecessary approvers to streamline the process and focus on the right content from the right stakeholders.
• Don’t require authors to approve documents. Their role is to create the content, not approve it, and a modern eDMS captures the authoring and workflow in the audit trail.
• Avoid conflicts of interest. Ensure approvers aren’t evaluating their own work.

Implementing these practices will improve the approval workflow and help ensure compliance standards are consistently met.

Moving Forward: Partnering for Success

Effectively managing drafts, reviews, and approvals isn't a one-time effort—it requires ongoing attention and refinement. By implementing these best practices, you can streamline workflows, enhance compliance, and reduce document clutter, helping your organization operate more efficiently.

If you're facing challenges with document management or Quality practices, I'd be happy to explore how we can work together to solve them. Please free to contact me.

Be sure to check out the full Part 2 video where I dive deeper into these topics, and stay tuned for Part 3, where we’ll cover document change control and document change requests.