**!! I edited this post 3 times since I felt I had clarify a few things
Hi everyone,**
I am looking for advice on setting up a strict Change Control workflow for a medical device company (following MDR/ISO 13485 regulations). We need to manage PDF documentation used by our sales team.
The Context:
-
Source: InDesign/Affinity (managed offline/internally).
-
Output: PDFs (distributed via Nextcloud).
-
Apps: Flow, Approval, Workflow Script (planned).
-
Feedback Mechanism: We plan to use Nextcloud’s native comments (sidebar), as our sales reps only have “Read” access to the files and cannot annotate the PDF directly.
The Required Workflow (Double Approval):
We need a process that separates the decision to change from the approval of the result.
-
Change Request (The Trigger):
-
A user (Sales Rep) finds an error in a published PDF.
-
They tag the file (e.g.,
Change Request) and add a description of the error in the Nextcloud comments sidebar.
-
-
Assessment (Approval Step 1):
-
The Regulatory Affairs Manager receives a notification.
-
They review the comment/request to decide if the change should be made.
-
Action: If approved, the file gets a new tag (e.g.,
Approved for Edit) and Marketing is notified.
-
-
Execution (Offline & Upload):
-
Marketing fixes the source file (InDesign) and exports a New PDF.
-
The New PDF is uploaded to a “Drafts” folder.
-
-
Verification (Approval Step 2):
-
The Regulatory Affairs Manager reviews the New PDF.
-
Action: If approved, the automated publication starts.
-
-
Publication & Logging (The Automation):
-
Swap: The New PDF replaces the Old PDF in the shared folder (preserving the filename/link is preferred).
-
Archive: The Old PDF is moved to an “Obsolete” folder.
-
MDR Log: A script appends a line to a master
ChangeLog.csvwith: Date, Filename, Requested By, Approved By, Comment content.
-
My specific questions:
-
Linking the chain: Since Step 1 happens on the Old File (where the comment is) and Step 4 happens on the New File, what is the best strategy to keep the “ticket information” intact across this gap?
-
File Replacement Strategy: Has anyone successfully scripted a “Replace and Archive” flow that maintains the original public link/file ID?
-
Logging: Can the Workflow Script app easily fetch the latest comment from a file to write it into the external log?
Any ideas on how to orchestrate this “Sandwiched” approval process (Approval → Work → Approval) in Nextcloud would be invaluable.