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Document History

View the complete history of a document.

Accessing History​

A document's history contains all information related to its lifecycle since creation.

View of applicable document

From the Document Record​

  1. Open the document

    • Search for and open the desired document
    • The document record is displayed

  2. Access the History tab

    • Click on the History or Versions tab

From the Portal​

My Documents:

  • Go to My Documents
  • Select a document
  • Click on History

Advanced Search:

  • Perform a search
  • In the results, History icon available

Understanding History​

History provides a complete chronological view of all document events.

Types of Tracked Events​

Lifecycle:

  • Initial creation
  • Submission for validation
  • Successive validations
  • Approvals or rejections
  • Implementation
  • Revisions
  • Archiving

Modifications:

  • Metadata changes
  • File replacements
  • Actor modifications (manager, approvers)
  • Distribution scope changes

Distribution:

  • Distributions performed (dates, recipients)
  • Acknowledgments of receipt
  • Questionnaire results

Requests:

  • Revision requests received
  • Processing and decisions

History Format​

History is presented as:

Chronological:

  • Most recent to oldest (or reverse according to preferences)
  • Date and time of each event
  • User who performed the action

By Event:

  • Action type
  • Event description
  • Before/after values (for modifications)
  • Associated comments

Available Filters​

You can filter history by:

  • Event Type: Validation, Modification, Distribution, etc.
  • User: Actions by a specific user
  • Period: Date range
  • Status: Events by document status

Versions and Modifications​

Version List​

View of applicable document

The Versions tab lists all document versions:

Version history

Viewing a Specific Version​

For each version, you can:

View the Record:

  • All metadata for this version
  • Actors at that time
  • Application scope

Download the Document:

  • Source file (according to format and rights)
  • PDF with watermark indicating version and status

View Specific History:

  • Events concerning only this version
  • Validation workflow
  • Distributions performed

Modification Summary​

For revised versions, the Modification Summary is displayed.

This summary helps quickly understand changes between versions.

Version Comparison​

Comparison functionality available:

  1. On the office template to compare

Compare version button

  1. Click on [Compare] or on the double arrow logo
  2. View differences:
    • Highlighted modifications
    • Metadata differences

Version comparison display

Audit Trail and Compliance​

Complete Traceability​

History constitutes the document's audit trail, required by many regulations.

Important Information: The complete audit trail of all application events is centralized in the Journal function accessible via the Administration browser. This function allows viewing all application logs and ensures global traceability beyond a document's specific history.

Regulatory Compliance:

  • FDA 21 CFR Part 11: Electronic records and signatures
  • ISO 13485: Quality management system for medical devices
  • EU GMP Annex 11: Computerised systems
  • EU MDR: Medical device regulation

Audit Information​

For each event, the audit trail records:

  • Who: Authenticated user
  • What: Action performed
  • When: Exact date and time
  • Where: Module and document concerned
  • Why: Comments and justifications (if applicable)

Immutability​

History is immutable:

  • No retroactive modification possible
  • Deletion prohibited
  • Integrity guarantee for regulatory audits

History Export​

Ability to export history:

  • PDF Format: For archiving or audit evidence
  • Excel Format: For analysis or reporting
  • Timestamping: Export date and time tracked

Practical Use Cases​

Investigation Following Non-Conformity​

In case of problems, history allows:

  • Identifying when the document was modified
  • Who validated the problematic version
  • Which users acknowledged receipt
  • Reconstructing the creation context

Audit Preparation​

History facilitates audit preparation:

  • Documented validation evidence
  • Training traceability (AR)
  • Workflow compliance
  • Adherence to internal procedures

Practice Analysis​

History allows analyzing:

  • Revision frequency
  • Average validation times
  • Approval/rejection rates
  • Origin of revision requests

Finding a specific version:

  • Document applicable on a given date
  • Version used during a production batch
  • Project document configuration

Best Practices​

Regular Consultation​

  • Review history before any revision
  • Check pending revision requests
  • Analyze reasons for previous revisions

Action Documentation​

  • Always add explanatory comments
  • Justify important decisions
  • Facilitate future understanding

Use in Training​

History is an excellent educational tool:

  • Show practice evolution
  • Explain document lifecycles
  • Illustrate regulatory compliance

Evidence Preservation​

  • Export history during audits
  • Archive distribution evidence
  • Retain according to regulatory periods

See Also: