QT9 reviewing a document request

This video provides a focused, procedural walkthrough demonstrating the correct method for reviewing and rejecting controlled documents within the QT9 Quality Management System (QMS). The primary goal of the tutorial is to ensure that document reviewers understand how to formally submit feedback and mandate changes, emphasizing the necessity of maintaining a complete and compliant record of the entire review cycle. The process begins with the reviewer accessing the QMS dashboard, identifying the pending document request, and downloading the "display copy" to thoroughly read and evaluate the content.

The core theme of the video centers on the critical distinction between informal communication and regulated workflow management. The presenter explicitly notes that while a reviewer might identify issues and communicate them informally—such as via email, phone call, or a conversation in the hallway—such methods are insufficient for regulated documentation. For any required change to be implemented, the document must be formally rejected through the QMS interface. This mandatory rejection forces the document owner to revise the content and resubmit it, ensuring that the final, approved version incorporates all necessary corrections.

The procedural demonstration highlights the use of the "Reject Request" function within QT9. Upon selecting this option, the system prompts the reviewer to provide a detailed explanation for the rejection. This text box is the single most important element for compliance, as it serves as the official, recorded communication channel for feedback. The reviewer must use this space to clearly articulate what specific corrections or changes are needed on the document before it can be approved. This mechanism ensures that a documented, traceable "back and forth conversation" is maintained within the QMS, satisfying regulatory requirements for audit trails and demonstrating that all feedback was collected and addressed before the document was officially released and put into use. The video concludes by normalizing the rejection process, stating that it is the intended and necessary mechanism for achieving quality control and ensuring the integrity of released documentation.

Key Takeaways: • Formal Rejection is Mandatory for Change: In a regulated QMS environment, if a reviewer identifies necessary corrections, the document must be formally rejected using the system's designated function; merely communicating changes informally (via email or conversation) is insufficient for compliance. • Maintaining the Audit Trail: The primary purpose of the formal rejection process within QT9 is to create a comprehensive, traceable record (audit trail) of all feedback, required changes, and subsequent revisions, which is essential for GxP and 21 CFR Part 11 compliance. • The Rejection Box as the Official Record: The text box provided when rejecting a request is the official, documented channel for providing feedback; reviewers must use this space to clearly and specifically articulate all required corrections or changes to the document owner. • Controlled Feedback Loop: The QMS enforces a controlled feedback loop, ensuring that the document owner cannot simply approve the document without addressing the reviewer’s concerns, as the rejection mandates a resubmission process. • Avoid Informal Communication for Regulated Content: While informal communication can be used to alert the document owner, it should never replace the formal, documented rejection and feedback process required by the QMS for controlled documents. • Rejection is a Quality Control Mechanism: Rejecting a document is not a failure but a necessary step in the quality control process, ensuring that the final released version is accurate, complete, and compliant with established procedures. • Accessing the Display Copy: Reviewers must always retrieve and review the "display copy" of the document within the QMS interface to ensure they are evaluating the specific version submitted for approval. • Document Ownership and Responsibility: The rejection process clearly places the responsibility back on the document owner to implement the specified changes and re-initiate the approval workflow.

Tools/Resources Mentioned:

• QT9: A specific Quality Management System (QMS) software platform used for managing controlled documentation, review workflows, and regulatory compliance.

Key Concepts:

• Controlled Documentation: Documents (such as SOPs, batch records, or quality manuals) that are subject to strict regulatory requirements regarding creation, review, approval, revision, and distribution, typically managed within a QMS.
• Audit Trail: A chronological, recorded sequence of events that provides documentary evidence of the history of a document, including who reviewed it, when they reviewed it, what feedback was provided, and when it was approved or rejected. Maintaining a robust audit trail is a core requirement of regulatory standards like 21 CFR Part 11.