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Paper distribution

Manage paper distribution of your documents.

Overview​

Paper distribution allows you to distribute printed documents to people who do not have access to the QDM application. This functionality is particularly useful for:

  • On-site personnel without computer access (workshops, production areas)
  • External partners without an account in the application
  • Regulatory paper archives
  • Compliance with certain industry requirements

Prerequisites​

Paper distribution can only be performed when the document is applicable, i.e., when the validation workflow is complete.

Paper distribution procedure​

1. Access the distribution function​

Paper distribution

  1. Open the applicable document in question
  2. In the action bar, expand the Distribute menu
  3. Select Paper distribution

Note: If this option is not available, contact your administrator to verify access rights.

2. Select recipients​

The paper distribution dialog box opens.

Default recipients:

By default, the application displays the list of people designated as paper recipients, i.e., referenced people who do not have direct access to the application.

Add or remove recipients:

  1. Click on Click here to add or remove recipients
  2. Select the people concerned by the distribution
  3. Validate your selection

3. Configure printing options​

The following options are available to customize your paper distribution:

OptionDescription
Print shipping slipGenerates a slip to keep track of paper distribution and record acknowledgments of receipt from recipients
Print cover pageAdds a cover page to the document before printing
Number of copiesPrint 1 copy per recipient or a specific number of copies (x copies based on x recipients)

4. Validate the distribution​

  1. Check the selected recipients and printing options
  2. Click Distribute to validate
  3. Documents are generated for printing

Paper distribution tracking​

In the document's Distribution area​

After validation, the document's Distribution area is updated and displays:

  • Names of paper recipients
  • Type of distribution (Paper)
  • Distribution date
  • Distribution status

Shipping slip​

If you have enabled the Print shipping slip option, it serves as proof of distribution and allows you to:

  • List all recipients
  • Collect handwritten signatures (paper acknowledgments of receipt)
  • Keep a physical record for audits
  • Archive distribution evidence

Slip content:

  • Document reference and title
  • Distribution date
  • List of recipients with signature space
  • Instructions for acknowledgment of receipt

Managing paper acknowledgments of receipt​

Manual AR recording​

Paper acknowledgments of receipt must be manually recorded in the system:

  1. Retrieve the signed slip
  2. Open the document in QDM
  3. Access the Paper distribution section
  4. Check the recipients who signed the slip
  5. Save the receipt date

Traceability​

Paper acknowledgments of receipt are tracked in the document history:

  • Paper distribution date
  • Date of receipt of signed ARs
  • User who recorded the information
  • Conservation of scanned slip (recommended)

Best practices​

Before distribution​

  • Verify that the document is finalized and applicable
  • Precisely identify recipients without computer access
  • Plan the number of copies needed
  • Systematically enable the shipping slip for traceability

Physical distribution​

  • Hand-deliver documents when possible
  • Use internal mail for remote sites
  • Systematically request a signature on the slip
  • Note the actual delivery date

Tracking and archiving​

  • Quickly record ARs in the system after receipt
  • Scan and attach signed slips to the electronic document
  • Follow up with recipients who have not signed
  • Archive physical slips according to regulatory timeframes

Regulatory compliance​

  • Keep signed slips according to applicable requirements
  • Ensure complete distribution traceability
  • Scan evidence to facilitate audits
  • Respect legal retention periods (ISO 13485, FDA 21 CFR Part 820, etc.)

Limitations and recommendations​

Paper distribution limitations​

  • Rapid obsolescence: In case of document revision, paper copies become obsolete
  • Complex management: Requires manual AR tracking
  • Costs: Printing, distribution, physical archiving
  • Reduced traceability: Less reliable than electronic distribution

Favor electronic distribution​

Whenever possible, favor electronic distribution which offers:

  • Automatic and unalterable traceability
  • Instant acknowledgments of receipt
  • Immediate updates in case of revision
  • Reduced printing costs
  • Enhanced compliance (21 CFR Part 11)

Paper distribution should remain the exception for cases where electronic access is impossible.

See also: