Should the primary document file be stored as a PDF?

If primary document files are stored in PDF format, then it will be necessary to store the native file as an additional file for each document. This will ensure people who revise the document in the future have the source to modify. The next section of this page provides the DCR workflow to store documents as a PDF; however, please consider the following points below.

• Creating and uploading both native and PDF files for every document may seem trivial when thinking about one DCR, but, eventually, you may have many DCRs flowing through the system at once. Document Control Coordinators may have an influx of work leading up to a product launch or submission, so it is worth considering ways to streamline the document release process.

• Another factor to consider is that every manual step in the process provides an opportunity to introduce errors. No matter how careful someone is about uploading final document files, there will be human errors. For example, the revision of a PDF may not match the revision of the corresponding Word file, or the uploaded Word file might be for the wrong document. Even if you have one document in your entire system with that kind of error, auditors seems to have a sixth sense that will lead them to that document every time! There is still a chance of human error in uploading final files, but eliminating the need to convert files to PDF removes a couple of manual steps as potential sources.

• In addition, all documents are under change control in Grand Avenue. This may require a cultural shift to thinking of the electronic QMS as the system of record. Even if someone downloads a Word source file and modifies it, the document can be revised in Grand Avenue only after the modified file is upload to a DCR, reviewed by a document control coordinator, and approved by the DCR reviewers. Along a similar line of reasoning, people are free to print any documents they need for reference as long as they check the printed revision against the Grand Avenue revision to ensure the printed copy is current prior to use.

• If you need PDF versions of controlled documents to send to customers, auditors, or suppliers, you can always convert them to PDF prior to sending.

DCR workflow for storing controlled documents as a PDF:

1. DCR originator searches for documents to be modified and downloads their respective native source files. These would be attached as an additional file to the document.

2. Modified files with tracked changes are uploaded to the DCR

3. The DCR is reviewed and approved

4. Documents in the DCR are released by a Document Control Coordinator. For each document, a coordinator would need to perform the following steps:

   1. Download the markup file

   2. Accept the tracked changes

   3. Convert the final file to PDF

   4. Upload the PDF as the primary document file

   5. Upload the native source file as an additional file for the document