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Quality control (QC) refers to the activities performed to ensure that the product being developed (any document type) adheres to the desired quality requirements. Its purpose is to verify the accuracy and precision of the content, the clarity of text and presentation, and the consistency of content, style, and format within the document (and across documents, if applicable). These activities are critical because mistakes can cause the reader to question the validity of the content and may lead to errors in interpretation.
The QC check can be split up into 2 parts: the editorial and content checks. The editorial check will verify correct usage of grammar and spelling, adherence to the required style guide to ensure consistency in punctuation, capitalization, cross-references, etc, as well as adherence to the appropriate format. The content check will focus on accuracy, clarity, and consistency of the information presented in the document. Although the content check is the most crucial part of the QC check, the editorial check may help to improve readability/clarity and to avoid distraction. If a document contains several small inconsistencies, it can detract attention from the key messages and disturb review. Hence, the value of the editorial check should not be underestimated.
In general, the formal QC check is done on a stable / near-final or final document using the final versions of the source documents. The content check should be conducted by another Medical Writer (who is not the author of the document) to allow an independent QC check; this person is called the QC Reviewer; however, it should be noted that other companies may use a different term. The editorial check can be executed by the author of the document supported by proofreading software, which may pick up certain issues more easily and faster when compared with manual verification, and is preferably scheduled prior to finalization.
Good and timely communication between the author of the document and the QC Reviewer(s) is essential. Given that the QC check may take some time depending on size and complexity of the document, the author is expected to foresee sufficient time, to provide the source material or point to the location, and to make clear agreements upfront (eg, prioritization of certain QC items, if needed). A staggered method can be applied if time is limited; for instance, stable non-data driven sections can already be checked earlier. An alternative solution for dealing with short timelines is to bring additional QC Reviewers on board.
It is best practice to include informal QC checks during the writing process (by the author or other person) to guarantee a high-quality document for the formal QC check. The QC Reviewer’s task is not to rectify the quality of the document, but to verify the quality of the document and to make corrections or suggestions where needed to reach the desired quality requirements. The fresh pair of eyes can spot mistakes or other issues that have escaped the author’s attention. A high-quality document will allow for a smooth QC check and does not end up in an overload of observations. Consequently, the QC Reviewer should be considered a ‘safety net’ that ensures that nothing is missed.
The Emtex Medical Writers can be responsible for the document development process (eg, writing sections, coordinating the review and consolidation of comments, and scheduling the QC activities). Our Emtex QC checklist (focusing on content) and Finalization checklist cover all important items to ensure a well-executed QC check as part of the document writing process. Standalone QC activities of documents not developed by Emtex can be performed according to our (or your own, or both) QC checklist & process.