Online Docgen - Generate Word Documents

Learn How to Efficiently Deliver Document to 510(k)/CE from Single Source

New Feature – Stop Duplicate Documents with Shared Common Data

Many of our customers often complain about having duplicate documents for their products after a few submissions. Back in the day, it was standard practice to manage similar documents using both Excel and word files in order to meet both FDA and CE requirements. Creating multiple copies of the same file with minor changes leads to design control management issues such as;

  • Traceability was complicated and needs double the effort to maintain it.
  • The project’s tracking becomes heavy and uncertain.
  • The maintainability of the common set of requirements across several documents impacts the reference documents such as RISK and V&V.

Orcanos system is able to generate multiple sets of documents from a single source of DOC without the need to duplicate your work items data.

The technique is simple. Specify in your filter a special condition that will collect all the requirements based on the information selected in each requirement record that is matching the selection information defined by that same custom field used in the source root DOC work item.

Step 1: Create a new custom field for the submission options of type multi-selection. (Ex.: 510(k), CE, All, etc.)

Step 2: Add to fields layout of both the DOC and the traceable item used under that document (Ex. SR, PR, SysRS, etc.)

Step 3: Create a special filter that presents all the items records under each heading that contains the traceable items. In the filter special criteria put the following SQL statement:

(Path like ((Select Path from OBJECTS Where ID=[$ME]) + (Select max(cast(Original_id as varchar)) from OBJECTS_VER_VIEW Where ID=[$ME]) + ‘\%’) or ID=[$ME]) AND 

(( select count(*) from fnSplitWord((select cs98 from objects ost where (select id from OBJECTS_VER_VIEW where Original_id=v.root_document and View_version=v.view_version)),’|’) where item in ( select * from fnSplitWord(v.cs98,’|’) ))>0)

Note: The CS## is the code of the custom field used for the submission path.

Step 4: Embed the filter under each heading.

Fig. Document for FDA Submission

Use Case: A single document that contains a set of specifications that needs to be printed out to different notify bodies. B However, not all the specifications are applicable, hence the need to filter out from the final document. In this case, we can allow the same document to be exported to WORD using the Multi Submission Data Generator.

Related Articles