Document Management Best Practices

Part 3 - Document Change Control and Document Change Requests

Part 2 of the Document Management Best Practices series dove into document lifecycles, focused on draft management, document review, and approvals. We’ll now continue our journey by focusing on Document Change Control and Document Change Requests.

1. Managing Change Effectively: Document Change Control

Document Change Control refers to a process for managing, tracking, and controlling changes throughout the life of a document. Without a well-defined process, inadequate assessments of scope, impact, and related documents can occur and lead to compliance gaps. I worked with a midsized CDMO where work instructions and forms were routinely missed when the related SOP was updated. This led to mismatches between the procedure and the “how-to” of the work and the form being completed.

Best Practices for Effective Document Change Control:

• Clearly capture rationale, impacts, and content changes. This clearly defines why the change is needed, the potential and actual impacts expected (including training), and what is changing between revisions, creating a clearly documented plan before moving forward.
• Gain upfront buy-in. Changes to documents should not surprise stakeholders and socializing change early helps to avoid delays later.
• Appropriately group documents. When documents are related, include them within the same Document Change Control so reviewers and approvers have a complete picture. When documents are unrelated, it’s generally best to route in separate Document Change Controls to avoid bloat and streamline implementation.
• Set realistic statuses and dates. If everything is urgent, nothing is. By setting realistic effectivity dates and not overusing emergency change processes, document approvals can be better managed and measured via reporting – all while ensuring truly urgent changes can be prioritized effectively.

By adopting these practices, you’ll achieve greater compliance and streamline your document change management.

2. Document Change Requests: The Voice-of-the-Customer

Document Change Requests are the avenue in which your consumers can provide feedback and request changes to documents. Capturing this feedback is essential in keeping your documents current, useful, and compliant. All too often I see this valuable feedback not appropriately captured - or, even if it is captured, the requests get pushed to the next change, and the next, and the next… A small CDMO I worked with had great intentions but were struggling with a feedback loop and monitoring. We’ll review some best practices so that you can build a simple, yet robust communications process with follow-up so you can keep your document content strong.

Best Practices for Document Reviews:

• Establish a process for creating/receiving requests, assessment, and triage. Documenting and assessing requests at regular intervals ensures that the changes are being evaluated and staged to incorporate as documents are revised. The great thing about this process is that it can be very simple with flexibility to scale over time – it can be as simple as a spreadsheet or Smartsheet form.
• Communication is key. By establishing a simple communication plan and feedback loops, you ensure your document authors know when feedback has been provided, and your requestors know when their feedback has been heard and reviewed, even if it isn’t incorporated. This helps build a Quality culture and lets consumers know their voice has been heard.
• Monitor the process. Creating reports to track requests ensures that the process is working. It also identifies cases where it isn’t working and provides an opportunity to improve over time.

Following these practices can increase the compliance and consistency of your documents and processes. It will also promote a Quality culture such that you’ll hear about potential issues and challenges earlier, helping to avoid potential Quality Events.

Moving Forward: Partnering for Success

Effectively managing document changes and requests comes down to having a sound process and effective communication. By implementing these best practices, you can improve compliance, become more efficient, and have better communication between your stakeholders – all of which will help your organization operate more effectively.

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 feel free to contact me.

Be sure to check out the full Part 3 video where I dive deeper into these topics, and stay tuned for Part 4, where we’ll cover periodic reviews and administrative changes.