Document implementation
This guide explains how to implement a document.
Implementation process
Implementation is the final stage of the document creation cycle, where the document officially becomes applicable within the organization.
Overview
After validation by approvers, the document can be implemented. This step marks the transition from "Validated" to "Applicable" status.
Main steps:
- Complete validation of the document by all approvers
- Implementation by the manager or administrator
- Automatic distribution to relevant recipients
- Document available for consultation with "Applicable" status
Validation workflow
The standard workflow includes the following steps:
Drafting → Submission → Validation(s) → Implementation → Applicable
Depending on configuration:
- One or more validation steps can be configured
- Parallel or sequential validation
- Optional verification step (quality control)
- Team-Connect collaborative step for simultaneous work
Collaborative step with Team-Connect
Team-Connect is an integrated collaborative space enabling simultaneous work on documents to mention users or notes concerning the document.
Features:
- Advanced integration with Microsoft Office
- Revision mode activated automatically
- Complete traceability of modifications
- Each contributor is identified
- Integrated comments and exchanges
Usage:
- Click on [Send to collaborative step]
- Designate collaborators
- Everyone can modify the document simultaneously
- Modifications are tracked in real time
- [Report my contribution] button to notify
- [End collaborative step] button to close
Validation
For approvers
When a document is submitted to you for validation:
- Notification: You receive a notification (email and/or portal)
- Document access: Click the link or access via My documents to process
- Review: Download and examine the document
- Decision:
- [Approve]: The document is compliant and can proceed to next step
- [Reject]: The document requires modifications (specify reasons)
- [Request modifications]: Comments and return to drafter
Comments: It is strongly recommended to add explanatory comments, especially in case of rejection.
Automatic notifications
The system automatically sends notifications:
- To drafter: submission confirmation
- To approvers: validation request
- To drafter: validation or rejection
- To manager: document ready for implementation
Validation deadlines
Depending on configuration, deadlines may be defined:
- Standard deadline: 5 working days (configurable)
- Automatic reminders: D-2 and D-1
- Possible escalation to hierarchy if exceeded
Distribution
Automatic distribution
Once the document is implemented, it is automatically distributed according to parameters defined during creation.
Automatic recipients:
- All users (global distribution)
- Users by department/process
- Specifically designated users
- Predefined distribution groups
Distribution types
Simple distribution: The document becomes available without action required from recipients.
Distribution with acknowledgment of receipt (AR): Recipients must confirm acknowledgment.
Distribution with questionnaire: An evaluation questionnaire may be associated to verify understanding.
See the Document distribution section for more details.
Implementation notification
Recipients are informed by:
- Notification email
- Alert on QDM portal
- "My pending acknowledgments" widget (if AR required)
Document consultation
Once implemented, the document:
- Appears in search results
- Is visible on the portal according to access scope
- Bears "Applicable" status with implementation date
- Is available for PDF download or online consultation
Post-implementation actions
Acknowledgment tracking
The manager can track ARs in real time:
- Dashboard with receipt rate
- List of latecomers
- Manual or automatic reminders
- Statistics export
Document watermarks
Depending on configuration, printed or downloaded documents may include an automatic watermark.
Watermark types:
- "Controlled copy" (for official documents)
- "Uncontrolled copy" (for working prints)
- "Applicable document"
Configuration: Configurable by document type according to your organization.
See Watermark management for more configuration details.
Correction without incrementation
Administrators can correct a document without incrementing the version number.
Use cases:
- Spelling corrections
- Formatting adjustments
- Minor corrections
This option preserves the current version number and does not require new distribution.
Best practices
Before implementation
- Verify that all approvers have validated
- Ensure distribution scope is correct
- Plan necessary time for reading by recipients
- Communicate in advance if major change
Communication
- Accompany distribution with clear communication
- Explain changes from previous version
- Specify effective date
- Identify expected actions from users
Monitoring
- Regularly monitor AR rate
- Follow up with latecomers
- Respond to user questions
- Archive distribution evidence (audit trail)
Document audit
Document audit is a periodic process that allows verification and extension of applicable document validity. This functionality is available depending on your application configuration.
Document audit principle
Each applicable document has two key dates:
- Implementation date: Date when the document becomes applicable (corresponds to validation workflow end date)
- Validity deadline: Date until which the document remains valid without requiring revision
Default period: The validity deadline is generally set at 3 years after implementation date, but this period can be configured differently according to your organization.
Why perform document audit?
Document audit allows to:
- Verify that the document still complies with current practices
- Extend validity without creating a new version (if content remains relevant)
- Maintain an up-to-date document repository
- Meet regulatory requirements (ISO 9001, ISO 13485, etc.)
Document audit procedure
If document audit is available in your form, a Document audits table is present in the document sheet.
Step 1: Access the function
- Open the applicable document concerned
- Locate the Document audits table listing previous audits
- Click the Document audit button
Step 2: Fill in audit information
The audit dialog box opens with the following fields:
| Field | Description | Completion |
|---|---|---|
| Audit performed on | Audit performance date | Automatically filled (current date) |
| Next audit on | Next audit date to plan | Automatically filled 2 years after current audit |
| Validity date | New document validity deadline | To be filled manually - Indicate until when the document remains valid |
| Comment | Free text area | Indicate audit observations, verified elements, or extension reasons |
Step 3: Validate the audit
- Complete all required fields
- Click Validate audit
- Window closes automatically
- Document is updated with new information
Audit result
After audit validation:
"Document audits" table update:
A new line is added to the table with:
- Audit performance date
- Next planned audit date
- New validity date
- Entered comment
- Auditor name
"Validity deadline" field update:
The document's Validity deadline field is automatically updated with the date entered during audit.
Validity date management
Depending on your application configuration, two cases may occur:
Configuration 1 - Modifiable validity date:
You can freely extend the validity date during audit, allowing to maintain the document applicable without revising it.
Configuration 2 - Non-modifiable validity date:
The validity date cannot be extended beyond a certain limit. This configuration forces document revision when validity deadline is reached, guaranteeing mandatory periodic content update.
Note: Depending on your settings, the validity deadline may not be modifiable in this interface to force revision when reaching the validity deadline.
Access rights
Document audit is generally reserved for:
- Document managers
- Quality managers
- Administrators
- Users with specific rights defined by administrator
If the Document audit button is not available, contact your administrator for rights verification.
Regulatory compliance
Document audit meets requirements of numerous standards:
- ISO 9001: Periodic review of management system documents
- ISO 13485: Verification of quality document validity for medical devices
- FDA 21 CFR Part 820: Document control and periodic review
- EU GMP: Regular review of pharmaceutical procedures
Complete audit traceability (dates, auditors, decisions) constitutes audit evidence to demonstrate rigorous document system management.
Document audit best practices
Audit planning:
- Respect next audit dates suggested by the system
- Plan audits in advance to avoid validity overruns
- Group audits by process or domain
Audit performance:
- Verify that the document still corresponds to current practices
- Consult document users to gather their feedback
- Verify regulatory compliance (standards, laws, customer requirements)
- Identify possible improvements
Documentation:
- Systematically fill the Comment field
- Indicate verified elements (practices, regulatory compliance, user feedback)
- Note actions to plan (future revision, training, etc.)
- Keep audit evidence (reports, emails, etc.)
Extension or revision decision:
- Extend validity: If document is still compliant and relevant
- Trigger revision: If modifications are necessary (via revision request)
Document audit thus allows maintaining a living and compliant repository without unnecessarily complicating the revision process.
Related articles
- Return to document lifecycle
- Previous article: Document revision
- Next article: Document history
- Document distribution - Manage distribution after implementation
- Distribution with AR - Track acknowledgments of receipt
- Document archiving - Manage document end-of-life