Module LabQC Pro EN: Difference between revisions

Jump to navigation Jump to search

Module LabQC Pro EN (view source)

Revision as of 15:16, 28 August 2026

3,370 bytes added ,  2 months ago
Updated LabQC Pro documentation to version 1.0.43, including CAPA & Deviation Manager integration, BatchSafe workflow, audit trail, reports and current requirements.
VisualWikitext
(→‎QC Specifications: Added LabQC Pro documentation images and completed module documentation.)
(Updated LabQC Pro documentation to version 1.0.43, including CAPA & Deviation Manager integration, BatchSafe workflow, audit trail, reports and current requirements.)
Line 3: Line 3:
=LabQC Pro=
=LabQC Pro=


'''LabQC Pro''' is a laboratory quality control module for Dolibarr designed to manage product-specific QC specifications, analytical testing, automatic PASS / FAIL evaluation, result approval and locking, audit trail, Certificate of Analysis (CoA), and Out of Specification (OOS) reports.
'''LabQC Pro''' is a laboratory quality control module for Dolibarr.


The module can work independently or optionally integrate with '''BatchSafe Pro''' for automatic batch/lot quality-status synchronization.
It provides a structured workflow from product-specific QC specifications and analytical testing to automatic PASS / FAIL evaluation, final approval, result locking, audit trail, Certificate of Analysis generation and OOS / deviation follow-up.


==Information==
LabQC Pro is designed for organizations that manage products by batch or lot and require documented quality-control decisions inside Dolibarr.


*'''Module name:''' LabQC Pro
The module can operate independently or integrate with '''BatchSafe Pro''' and '''CAPA & Deviation Manager'''.
*'''Current version:''' 1.0.40
*'''Author:''' Vasile Panciuc
*'''Publisher:''' PanciucSoft
*'''License:''' GNU GPL v3 or later
*'''Support:''' support@panciucsoft.com
*'''Dolibarr compatibility declared on DoliStore:''' V18 - V23
*'''Validated clean installation:''' Dolibarr 23.0.3
*'''Languages:''' English, Romanian
*'''BatchSafe Pro:''' Optional


==Introduction==
==Overview==


LabQC Pro provides a structured quality control workflow directly inside Dolibarr.
LabQC Pro adds a complete laboratory quality-control workflow to Dolibarr.


The typical workflow is:
Typical workflow:


'''QC Specification → QC Test → Analytical Results → Automatic PASS / FAIL → Finalization & Locking → CoA or OOS Report'''
'''QC Specification → QC Test → Analytical Results → Automatic PASS / FAIL → Finalization & Locking → CoA / OOS Report → Optional CAPA / Deviation'''


The module is suitable for organizations that manage products by batch or lot and need traceable laboratory quality-control records.
Main capabilities include:
 
[[File:LabQC Pro Overview.png|frameless|900x900px]]
 
 
==Main features==


*Product-specific QC specifications
*Product-specific QC specifications
*Specification version management
*Specification version management
*Analytical parameters and acceptance criteria
*Analytical parameters and acceptance criteria
*Numeric and text-based laboratory results
*Numeric and text-based analytical results
*Mandatory analytical parameters
*Mandatory QC parameters
*QC tests linked to existing Dolibarr product batches / lots
*QC tests linked to real Dolibarr batches / lots
*Automatic PASS / FAIL evaluation
*Automatic PASS / FAIL evaluation
*Finalization and permanent result locking
*Finalization and permanent result locking
*Laboratory Analyst and QC Manager permission workflow
*Role-based laboratory workflow
*Immutable Audit Trail
*Immutable Audit Trail
*Previous and new value tracking
*Previous and new value tracking
*User and timestamp history
*Certificate of Analysis generation
*Certificate of Analysis generation for PASS tests
*OOS / QC Test Report generation
*OOS / QC Test Report generation for FAIL tests
*BatchSafe Pro synchronization
*Tested by / Approved by information
*CAPA & Deviation Manager integration
*Approval date and signature fields
*Responsive desktop and mobile interface
*Responsive desktop and mobile interface
*English and Romanian interface
*English and Romanian interface
*Optional BatchSafe Pro integration
==User roles==
===Lab Analyst===
The Laboratory Analyst can:
*Create QC tests
*Select the product, specification and real Dolibarr lot
*Enter analytical results
*Save and recalculate results
*Trigger automatic PASS / FAIL evaluation
The Laboratory Analyst should not finalize or approve QC tests unless the corresponding permission is granted.
===QC Manager===
The QC Manager can:
*Review analytical results
*Review PASS / FAIL verdicts
*Finalize and lock QC tests
*Approve the final QC decision
*Review the Audit Trail
*Generate CoA or OOS reports


==QC Specifications==
==QC Specifications==


A QC Specification defines the analytical requirements for a product.
QC Specifications define the quality requirements that a product must meet.


Each specification may contain:
A specification can contain:


*Product
*Product
*Reference
*Specification reference
*Label
*Specification version
*Version
*Status
*Description
*Analytical parameters
*Analytical parameters
 
*Test method
Each analytical parameter may define:
*Acceptance criteria
 
*Units
*Parameter name
*Mandatory / optional parameter status
*Analytical method
*Acceptance criterion
*Mandatory status


Example:
Example:
Line 106: Line 59:
!Parameter
!Parameter
!Method
!Method
!Acceptance criterion
!Acceptance criteria
!Mandatory
!Mandatory
|-
|-
|Assay
|Assay
|HPLC
|HPLC
|98 - 102 %
|98–102 %
|Yes
|Yes
|-
|-
Line 120: Line 73:
|}
|}


[[File:LabQC Pro QC Specifications.png|frameless|850x850px]]
Specifications can be versioned so that the quality requirements used for a QC test remain identifiable and traceable.


==QC Tests==


==QC Tests==
A QC Test links laboratory analysis to a specific product and batch / lot.


A QC Test is linked to:
Typical QC Test information includes:


*A Dolibarr product
*QC test reference
*A QC specification
*Product
*An existing Dolibarr batch / lot
*Batch / lot
*A test date
*QC specification
*Specification version
*Test status
*Analytical results
*Analytical results
*Analyst
*Approval / finalization information
A QC test can contain multiple analytical parameters taken from the selected QC specification.
==Analytical results==
Analytical results can be entered for each QC parameter.
Depending on the parameter configuration, LabQC Pro can support:


The module retrieves existing Dolibarr product lots, which helps maintain traceability between laboratory testing and physical stock.
*Numeric results
*Text-based results
*Acceptance limits
*Required parameters
*Individual PASS / FAIL evaluation
 
The result screen clearly displays the measured value, acceptance criteria and parameter verdict.


==Automatic PASS / FAIL evaluation==
==Automatic PASS / FAIL evaluation==


LabQC Pro evaluates entered analytical results against the approved specification.
LabQC Pro automatically evaluates QC results against the configured specification.


Example:
Typical behavior:
 
*All mandatory parameters within specification → '''PASS'''
*One or more mandatory parameters outside specification → '''FAIL / OOS'''
*Missing mandatory results → test cannot be considered complete


{| class="wikitable"
Automatic evaluation reduces manual verdict entry and helps keep laboratory decisions consistent with the active specification.
!Parameter
!Specification
!Result
!Verdict
|-
|Assay
|98 - 102 %
|100 %
|PASS
|-
|Appearance
|White tablets
|White tablets
|PASS
|}


If one or more mandatory analytical parameters fail, the final QC test status becomes '''FAIL'''.
==Finalization and locking==


==Finalization and result locking==
QC results remain editable while the test is open.


After results are reviewed, an authorized QC Manager can finalize the QC test.
After review, an authorized QC Manager can finalize the test.


Finalization:
Finalization:


*Records the final QC verdict
*Records the approving user
*Records the approving user
*Records the approval date and time
*Records the finalization date and time
*Stores the final PASS or FAIL decision
*Locks the analytical results
*Locks laboratory results against further modification
*Prevents silent modification of finalized data
*Creates an Audit Trail event
*Enables final quality reporting
 
A finalized QC test becomes a permanent quality-control record.
 
==Suggested user roles==
 
===Laboratory Analyst===
 
Typical permissions and responsibilities:
 
*Create QC tests
*Select product and batch / lot
*Enter analytical results
*Review parameter evaluation
*Trigger automatic PASS / FAIL evaluation


Once finalized, analytical results become read-only.
===QC Manager===
 
Typical permissions and responsibilities:
 
*Review completed analytical results
*Review PASS / FAIL evaluation
*Finalize and lock QC tests
*Approve final quality decisions
*Review Audit Trail
*Generate CoA and OOS reports
*Initiate CAPA / deviation follow-up when required
 
The exact Dolibarr permissions can be configured according to the organization's internal procedures.


==Certificate of Analysis==
==Certificate of Analysis==


A finalized PASS test can generate a '''Certificate of Analysis (CoA)'''.
Finalized PASS tests can generate a '''Certificate of Analysis (CoA)'''.


The generated PDF contains:
The report can include:


*Product
*Product
*Batch / Lot
*Batch / lot
*QC specification
*QC specification
*Test date
*Specification version
*Final QC status
*Overall result
*Analytical parameters
*Analytical parameters
*Methods
*Specifications
*Results
*Results
*Verdicts
*Acceptance criteria
*Individual verdicts
*Overall PASS verdict
*Tested by
*Tested by
*Approved by
*Approved by
*Approval date
*Approval date
*Signature field
The final decision is displayed as '''Approved'''.


The CoA provides a structured summary of the finalized laboratory decision.


==OOS / QC Test Report==
==OOS / QC Test Report==


A finalized FAIL test can generate an '''OOS / QC Test Report'''.
Finalized FAIL tests can generate an '''OOS / QC Test Report'''.


The report identifies failed analytical parameters and displays:
The report can include:


*Final QC status: FAIL
*Product
*Overall result: Out of Specification (OOS)
*Batch / lot
*Failed analytical results
*QC specification
*Final decision: Rejected
*Analytical results
*Tested by
*Failed parameters
*Approved by
*Acceptance criteria
*Approval date
*Final FAIL / OOS verdict
*Signature field
*Analyst and approval information


[[File:LabQC Pro Certificates Reports.png|frameless|850x850px]]
The report can be used as the starting point for further investigation or deviation management.


==Audit Trail==
==Audit Trail==


LabQC Pro includes an immutable Audit Trail for important QC events.
LabQC Pro records important quality-control events.


Recorded events include:
Audit Trail entries can include:
 
*QC test creation
*Result updates
*Status changes
*Test finalization
 
Each event can record:


*User
*Date and time
*Date and time
*QC test reference
*Action
*Object
*Object
*User
*Event / action
*Previous value
*Previous value
*New value
*New value
*Note
*Note


The Audit Trail is available on both desktop and mobile layouts.
Typical recorded events include:
 
*QC test creation
*Result entry or modification
*Status changes
*PASS / FAIL evaluation
*Finalization


[[File:LabQC Pro Audit Trail.png|frameless|850x850px]]
This provides traceability of important laboratory actions and supports internal review and audit activities.


==BatchSafe Pro integration==
==BatchSafe Pro integration==


BatchSafe Pro integration is optional.
When '''BatchSafe Pro''' is installed and enabled, LabQC Pro can synchronize QC decisions with lot operational status.
 
When BatchSafe Pro is installed and enabled, LabQC Pro can automatically synchronize lot quality status.


Typical workflow:
Typical workflow:
Line 252: Line 232:
{| class="wikitable"
{| class="wikitable"
!LabQC event
!LabQC event
!BatchSafe Pro status
!BatchSafe status
|-
|-
|QC test opened
|New QC test opened
|Under inspection
|-
|QC test in progress
|Under inspection
|Under inspection
|-
|-
Line 267: Line 244:
|}
|}


LabQC Pro also works normally when BatchSafe Pro is not installed or is disabled.
This allows laboratory quality decisions to influence warehouse lot availability automatically.
 
Existing manual critical holds can be preserved instead of being silently overwritten by automatic synchronization.
 
For example, if a lot is already manually Rejected or Recalled for another critical reason, LabQC Pro can preserve that status and display an informational message rather than replacing it.
 
BatchSafe Pro integration is optional.
 
LabQC Pro continues to work independently when BatchSafe Pro is not installed or disabled.
 
==CAPA & Deviation Manager integration==
 
Starting with LabQC Pro 1.0.43, finalized FAIL / OOS tests can be integrated with '''CAPA & Deviation Manager'''.
 
A linked deviation can be created directly from the QC test.
 
Typical workflow:
 
'''QC Test → FAIL / OOS → Finalization → Create CAPA / Deviation → Investigation → Corrective / Preventive Action'''
 
The deviation form can be prefilled with information from the originating laboratory test, including:
 
*Source module
*QC test reference
*Product
*Batch / lot
*QC specification
*Severity
*Department
*Relevant QC context
 
Example source reference:
 
'''LabQC Pro · QCT-YYYYMMDD-HHMMSS'''
 
This reduces duplicate data entry and keeps the deviation linked to the original laboratory result.
 
After a deviation has been created, LabQC Pro can recognize the existing linked record and provide an '''Open CAPA Deviation''' action instead of creating unnecessary duplicates.
 
The deviation description remains readable and editable when opened or modified.
 
CAPA & Deviation Manager integration is optional.
 
LabQC Pro continues to work independently when CAPA & Deviation Manager is not installed.
 
==Product and lot traceability==
 
QC tests can be linked to real Dolibarr products and lot / serial records.
 
This helps maintain traceability between:
 
*Product
*Batch / lot
*QC specification
*Analytical results
*Final QC verdict
*BatchSafe status
*CAPA / deviation record when applicable
 
==Mobile support==
 
LabQC Pro includes a responsive interface suitable for desktop, tablet and smartphone use.
 
The mobile interface supports:
 
*QC test review
*Analytical result entry
*PASS / FAIL visibility
*Finalization information
*Audit Trail access
*BatchSafe status display
*CAPA / deviation actions
*Responsive tables and result cards


==Installation==
==Installation==


#Download the LabQC Pro ZIP package.
#Download the LabQC Pro module package.
#In Dolibarr, go to '''Home → Setup → Modules/Applications'''.
#Go to '''Home → Setup → Modules/Applications''' in Dolibarr.
#Use the external module deployment function.
#Use the external module deployment / installation function.
#Upload the LabQC Pro ZIP package.
#Upload the LabQC Pro ZIP package.
#Activate '''LabQC Pro'''.
#Enable '''LabQC Pro'''.
#Configure user permissions.
#Configure user permissions.
#Ensure Products, Stock and Lot / Serial management are enabled if lot-based QC is required.
#Make sure Products, Stock and Lot / Serial management are enabled when batch-based QC is required.
 
The module has also been validated on a clean Dolibarr 23.0.3 installation.


==Basic configuration==
==Basic configuration==


Before creating QC tests:
After activation:


#Create or select a Dolibarr product.
#Create or select a product.
#Enable lot / serial management for the product.
#Make sure the product uses lot / serial management when required.
#Create a warehouse.
#Add stock using a real lot number.
#Create a QC Specification for the product.
#Create a QC Specification for the product.
#Add analytical parameters.
#Add analytical parameters and acceptance criteria.
#Create a QC Test and select the existing lot.
#Create a QC Test linked to a product and batch / lot.
#Enter analytical results.
#Review automatic PASS / FAIL evaluation.
#Finalize the QC Test using an authorized QC Manager account.
#Generate the appropriate CoA or OOS report.
 
Optional integrations can then be enabled by installing BatchSafe Pro and / or CAPA & Deviation Manager.
 
==Requirements==
 
*Dolibarr V18 to V23
*PHP 7.4 or later
*Products module
*Stock / warehouse management
*Lot / Serial management for batch-based QC workflows
 
Optional:
 
*'''BatchSafe Pro''' for lot-status synchronization
*'''CAPA & Deviation Manager''' for deviation and CAPA follow-up
 
==Version==


==Mobile support==
Current documented version:
 
'''LabQC Pro 1.0.43'''
 
==Languages==
 
LabQC Pro includes:
 
*English
*Romanian
 
Additional translations can be added using the standard Dolibarr translation mechanism.
 
==Typical use cases==
 
LabQC Pro can be used in organizations such as:
 
*Laboratories
*Pharmaceutical companies
*Food and supplement manufacturers
*Chemical manufacturers
*Manufacturing companies
*Quality-controlled warehouses
*Organizations using batch / lot-based product quality control
 
==Documentation workflow example==
 
A typical integrated workflow may look like:
 
'''Product / Lot'''
 
↓
 
'''QC Specification'''
 
↓
 
'''QC Test'''
 
↓
 
'''Analytical Results'''
 
↓
 
'''Automatic PASS / FAIL'''
 
↓
 
'''QC Manager Finalization'''


LabQC Pro includes responsive layouts for:
↓


*Dashboard
'''PASS → CoA → BatchSafe Released'''
*QC Specifications
*QC Tests
*Analytical result entry
*Finalized test review
*Certificates / OOS
*Audit Trail


This allows laboratory and QC users to review or enter information from mobile devices.
or


[[File:LabQC Pro Mobile.png|frameless|850x850px]]
'''FAIL / OOS → OOS Report → BatchSafe Rejected → CAPA / Deviation'''


==Support==
==Support==


For support, installation questions or bug reports:
Support and product information:


'''Email:''' support@panciucsoft.com
'''support@panciucsoft.com'''


'''Publisher:''' PanciucSoft
LabQC Pro is developed by '''PanciucSoft'''.


==License==
==License==


LabQC Pro is distributed under the '''GNU General Public License version 3 or later (GPL-3.0-or-later)'''.
LabQC Pro is distributed under the '''GNU GPL v3 or later''' license.


==Regulatory notice==
==Regulatory notice==


LabQC Pro provides software workflow features for laboratory quality control.
LabQC Pro provides software tools for laboratory quality-control workflows.
 
Validation, qualification, electronic-signature requirements, data-retention rules and suitability for GMP, GLP, GxP, ISO, pharmaceutical, medical or other regulated use remain the responsibility of the organization deploying the module.
 
==See also==


*[[Dolibarr]]
The module does not replace an organization's quality management system, standard operating procedures, validation activities, qualification activities or legally required controls.


[[Category:Complementary modules]]
Validation, qualification and compliance with GMP, GLP, GxP, ISO or other regulatory requirements remain the responsibility of the organization using the module.
Mikrosha2000
222

edits

Retrieved from "https://wiki.dolibarr.org/index.php/Special:MobileDiff/67106"

Navigation menu