Understand the Raiana Consistency Checker

Raiana Consistency Checker helps regulatory affairs and quality professionals determine whether selected definitions are used consistently throughout technical documentation. It examines the selected documents, identifies relevant passages for the phrase or phrases you specify, compares the wording and meaning across documents, and provides cross-references so that you can investigate and resolve inconsistencies.

Prepare the document set

1. Select an Evidence folder. The files used for a check must be in the same folder. In the middle of the screen, select the folder under the Evidence folder heading.

   

2. Choose the folder from Raiana Enterprise. After selecting the Evidence folder field, review the folders available in your Raiana Enterprise solution and select the folder containing the documentation you want to compare. A list of files will load on the left side of the interface. If the folder you wish to use is not in the list, it must first be added to the Enterprise environment.

3. Confirm the selected documentation. In the example, the selected folder contains synthetic technical documentation for an in-vitro diagnostic product concerning Lyme disease. This is not a real product; Raiana created the documentation for training purposes. Use the same selection process for the documentation set you need to review. Confirm all desired documents are present.

Specify the definitions to check

Choose the definition or phrase whose use you want to compare across the selected documents. Raiana provides preset phrases, including Intended Purpose and Patient Population, so you can select one of these when it matches your review objective.

You can also provide another phrase when the preset choices do not cover your requirement. For the example IVD documentation, enter Sensitivity as the additional phrase to investigate. This lets you check a product-specific definition rather than limiting the review to the preset phrases.

Run the consistency check

Start the consistency check after selecting the Evidence folder and specifying the phrase or phrases. Raiana then goes through the documents in the selected folder, looking for references to the requested phrase and determining whether its phrasing and definition are consistent with the corresponding content in the other documents. It extracts relevant passages from each document when such passages exist. Not every document will necessarily discuss the selected phrase; in the example, some documents do not mention Sensitivity. For documents that do contain a definition, Raiana compares the definitions and creates cross-references between them.

Interpret the comparison matrix

When processing is complete, review the comparison matrix. The matrix dimension depends on the number of documents in which Raiana found relevant information. In the example, eight documents contain relevant information, so the matrix compares those eight documents rather than necessarily representing every document in the selected folder. Use the table below the chart to identify which document corresponds to each number in the matrix. This mapping is necessary because the matrix uses document numbers rather than displaying the full document names in every cell. Use the color legend to interpret the comparison results. Green indicates that the wording for the selected phrase is exactly identical, which is the ideal outcome. Other results indicate varying degrees of difference; use the legend and the associated comparisons to distinguish equivalent wording from differences in meaning.

Remember that the matrix is symmetrical: the comparison between document 1 and document 2 is the same as the comparison between document 2 and document 1. A result can show equivalent wording, meaning that the regulatory meaning is the same even though the formulation differs, or it can show a different meaning that requires closer investigation.

Inspect individual discrepancies

Select a matrix item to inspect the underlying comparison. Raiana displays the two meanings associated with the selected pair of documents, allowing you to move from the summary result to the actual definitions that produced it.

Compare the displayed passages carefully. One document may contain two mentions of Sensitivity, while another may contain different definitions or other related statements. The comparison shows whether the wording differs while the meaning remains the same, or whether the documents describe Sensitivity differently. Use this evidence to locate the affected documentation and determine how the technical documentation should be aligned.

Export the report as a PDF

Instead of opening matrix items one at a time, use the PDF export option to create a report of the complete consistency check. Choose the export-as-PDF action when you need a document that can be reviewed, retained, or used to track down inconsistencies across the technical documentation.

After you export as PDF, Raiana presents the entire report as a PDF. The report includes the comparison matrix, the legend needed to interpret its colors, and the individual comparisons. Use these sections together to identify inconsistent definitions, trace them to the relevant documents, and support the work of resolving the inconsistencies in your technical documentation.