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Updated LabQC Pro documentation for v1.1.0: redesigned interface, QC workflows, CAPA/BatchSafe integrations, CoA/OOS reports, security improvements and new screenshots.
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(Updated LabQC Pro documentation for v1.1.0: redesigned interface, QC workflows, CAPA/BatchSafe integrations, CoA/OOS reports, security improvements and new screenshots.)
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{{DISPLAYTITLE:Module LabQC Pro}}


=LabQC Pro=
'''LabQC Pro''' is a laboratory quality-control module for Dolibarr that manages analytical specifications, QC testing, automatic PASS / FAIL evaluation, controlled approval, result locking, audit history and laboratory reporting.


'''LabQC Pro''' is a laboratory quality control module for Dolibarr.
It is intended for laboratories, manufacturers, pharmaceutical and food businesses, and other organizations that require traceable quality decisions for products and batches/lots.


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.
The module can be used independently or with optional '''BatchSafe Pro''' and '''CAPA & Deviation Manager''' integrations.


LabQC Pro is designed for organizations that manage products by batch or lot and require documented quality-control decisions inside Dolibarr.
[[File:00_Cover_LabQC_Pro.png|600px|center|LabQC Pro – Laboratory Quality Control Management for Dolibarr]]


The module can operate independently or integrate with '''BatchSafe Pro''' and '''CAPA & Deviation Manager'''.
==Overview==
 
LabQC Pro provides a structured workflow within Dolibarr:
 
'''QC Specification → QC Test → Analytical Results → Automatic PASS / FAIL → QC Manager Finalization → CoA / OOS Report'''


[[File:Labqcpro-cover.png|800x800px]]
If optional integrations are enabled, finalized QC outcomes can also support batch-status management and CAPA/deviation follow-up.


==Overview==
===Key features===
 
*Product-specific QC specifications and version references
*Analytical parameters, methods, units and acceptance criteria
*Numeric ranges and text-based acceptance criteria
*Mandatory analytical parameters
*QC tests linked to products and existing Dolibarr batches/lots
*Automatic individual and overall PASS / FAIL evaluations
*Separation of Laboratory Analyst and QC Manager duties
*Finalization and locking of analytical results
*Audit history with user, time, previous values and new values
*Certificate of Analysis (CoA) PDF reports for finalized PASS tests
*OOS / QC Test Report PDFs for finalized FAIL tests
*Optional links to CAPA & Deviation Manager and BatchSafe Pro
*Responsive desktop and mobile interface
*English and Romanian translations
 
==What's new in LabQC Pro 1.1.0==


LabQC Pro adds a complete laboratory quality-control workflow to Dolibarr.
Version '''1.1.0''' is a major interface, workflow and reliability update.


Typical workflow:
*Redesigned Dashboard with QC statistics and workflow shortcuts
*Modernized QC Specifications, QC Tests, Certificates/OOS and Audit Trail screens
*Improved desktop and smartphone layouts for forms, lists and analytical results
*Refreshed CoA and OOS PDF layouts with approval traceability
*Better CAPA/deviation linking from finalized FAIL / OOS QC tests
*Additional safeguards to preserve existing BatchSafe manual holds and rejected statuses
*Strengthened server-side permission and entity checks on key QC operations
*Improved validation of analytical limits and result-saving integrity
*Continued use of the existing module identifier and permission identifiers for upgrades


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


Main capabilities include:
The Dashboard displays the number of QC specifications and tests, including PASS, FAIL/OOS and in-progress results. It also provides direct links to the principal QC workflow steps.


*Product-specific QC specifications
[[File:01_Dashboard.png|600px|center|LabQC Pro 1.1.0 Dashboard]]
*Specification version management
*Analytical parameters and acceptance criteria
*Numeric and text-based analytical results
*Mandatory QC parameters
*QC tests linked to real Dolibarr batches / lots
*Automatic PASS / FAIL evaluation
*Finalization and permanent result locking
*Role-based laboratory workflow
*Immutable Audit Trail
*Previous and new value tracking
*Certificate of Analysis generation
*OOS / QC Test Report generation
*BatchSafe Pro synchronization
*CAPA & Deviation Manager integration
*Responsive desktop and mobile interface
*English and Romanian interface


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


QC Specifications define the quality requirements that a product must meet.
QC Specifications define the quality requirements for a Dolibarr product. Each specification includes a reference, label, version and status, and may contain several analytical parameters.
 
[[File:02_QC_Specifications.png|600px|center|QC specifications overview and creation]]
 
===Specification details===
 
A specification stores its associated product and version, along with a description and status. These details identify the acceptance criteria selected for testing.
 
[[File:03_Specification_Details.png|600px|center|LabQC Pro specification details]]
 
===Analytical parameters===


A specification can contain:
Analytical parameters define the method, criterion type, minimum and maximum limits or required text, measurement unit and mandatory/optional status.


*Product
[[File:04_Analytical_Parameters.png|600px|center|Analytical parameter definitions and acceptance criteria]]
*Specification reference
*Specification version
*Analytical parameters
*Test method
*Acceptance criteria
*Units
*Mandatory / optional parameter status


Example:
Example:
Line 61: Line 76:
!Parameter
!Parameter
!Method
!Method
!Acceptance criteria
!Acceptance criterion
!Mandatory
!Mandatory
|-
|-
Line 72: Line 87:
|Visual
|Visual
|White tablets
|White tablets
|Yes
|-
|pH
|Potentiometric
|5–7 pH
|Yes
|Yes
|}
|}


Specifications can be versioned so that the quality requirements used for a QC test remain identifiable and traceable.
''The values above are examples only; each organization must define and approve its own analytical methods and specifications.''
 
[[File:Labqcpro-qc-specifications.png|800x800px]]


==QC Tests==
==QC Tests==


A QC Test links laboratory analysis to a specific product and batch / lot.
Each QC Test is associated with a Dolibarr product, an applicable QC specification and a batch/lot. Users can enter a test date, reference and notes.


Typical QC Test information includes:
[[File:05_QC_Tests.png|600px|center|QC Test creation and PASS / FAIL overview]]


*QC test reference
A QC test can hold multiple analytical results. Each result is evaluated against its applicable acceptance criterion.
*Product
*Batch / lot
*QC specification
*Specification version
*Test status
*Analytical results
*Analyst
*Approval / finalization information


A QC test can contain multiple analytical parameters taken from the selected QC specification.
===Automatic evaluation===


==Analytical results==
*'''PASS:''' the required analytical results satisfy the selected criteria.
*'''FAIL / OOS:''' at least one required analytical result does not satisfy the selected criteria.
*'''Incomplete:''' mandatory results have not all been provided; the test is not ready for finalization.


Analytical results can be entered for each QC parameter.
Users with analytical-result permissions can save results and recalculate the verdict while the QC test remains open.


Depending on the parameter configuration, LabQC Pro can support:
===Finalization, locking and deviation follow-up===


*Numeric results
An authorized QC Manager can finalize a complete QC test. The operation records the final verdict, responsible user and timestamp, and locks the results against ordinary editing.
*Text-based results
*Acceptance limits
*Required parameters
*Individual PASS / FAIL evaluation


The result screen clearly displays the measured value, acceptance criteria and parameter verdict.
For finalized FAIL / OOS tests, the interface can show a link to a related CAPA/deviation record or an action to create one when the optional CAPA module is installed.


==Automatic PASS / FAIL evaluation==
[[File:06_QC_Finalization_CAPA.png|600px|center|Finalized QC test and linked CAPA deviation]]


LabQC Pro automatically evaluates QC results against the configured specification.
===Analytical results and traceability===


Typical behavior:
The detailed QC test screen presents each analytical parameter, method, specification, measured result and PASS / FAIL verdict. Finalized records are displayed as read-only.


*All mandatory parameters within specification → '''PASS'''
[[File:07_Analytical_Results.png|600px|center|QC analytical results and locked finalized record]]
*One or more mandatory parameters outside specification → '''FAIL / OOS'''
*Missing mandatory results → test cannot be considered complete


Automatic evaluation reduces manual verdict entry and helps keep laboratory decisions consistent with the active specification.
==Certificates of Analysis and OOS Reports==


[[File:labqcpro-qc-tests-pass-fail.png|800x800px]]
Reports are available for finalized QC tests:


==Finalization and locking==
*'''Certificate of Analysis (CoA):''' generated for a finalized PASS test.
*'''OOS / QC Test Report:''' generated for a finalized FAIL test.


QC results remain editable while the test is open.
The reports identify the product, batch/lot, QC specification, results and acceptance criteria, final decision and recorded approval information.


After review, an authorized QC Manager can finalize the test.
[[File:08_Certificates_OOS.png|600px|center|Certificate of Analysis and OOS report list]]


Finalization:
===Sample PDF layouts===


*Records the final QC verdict
The following image illustrates the two PDF report types generated by LabQC Pro.
*Records the approving user
*Records the finalization date and time
*Locks the analytical results
*Prevents silent modification of finalized data
*Enables final quality reporting


A finalized QC test becomes a permanent quality-control record.
[[File:10_CoA_OOS_PDF_Examples.png|600px|center|LabQC Pro CoA and OOS PDF examples]]


==Suggested user roles==
''Recorded approval details are not represented as a certified cryptographic electronic signature.''


===Laboratory Analyst===
==Audit Trail==


Typical permissions and responsibilities:
LabQC Pro records important actions associated with QC tests, including:


*Create QC tests
*Creation of a QC test
*Select product and batch / lot
*Entry or modification of analytical results
*Enter analytical results
*Recalculation of the QC test status
*Review parameter evaluation
*Finalization and locking
*Trigger automatic PASS / FAIL evaluation


===QC Manager===
The audit history displays event time, QC test, action, related object, user, previous value, new value and a note where applicable.


Typical permissions and responsibilities:
[[File:09_Audit_Trail.png|600px|center|LabQC Pro Audit Trail showing QC history and user actions]]


*Review completed analytical results
The application audit history supports traceability. Organizations remain responsible for database access controls, backups, retention and any applicable compliance validation.
*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.
==User permissions and recommended roles==


==Certificate of Analysis==
LabQC Pro provides separate permissions for reading QC information, managing specifications, creating tests, entering results, finalization, reporting and Audit Trail access.


Finalized PASS tests can generate a '''Certificate of Analysis (CoA)'''.
{| class="wikitable"
 
!Permission
The report can include:
!Laboratory Analyst (example)
 
!QC Manager (example)
*Product
|-
*Batch / lot
|Read LabQC Pro quality control data
*QC specification
|Yes
*Specification version
|Yes
*Analytical parameters
|-
*Results
|Create or modify QC specifications and analytical parameters
*Acceptance criteria
|No
*Individual verdicts
|No
*Overall PASS verdict
|-
*Tested by
|Create QC tests
*Approved by
|Yes
*Approval date
|No
 
|-
The CoA provides a structured summary of the finalized laboratory decision.
|Enter or modify analytical results
 
|Yes
==OOS / QC Test Report==
|No
 
|-
Finalized FAIL tests can generate an '''OOS / QC Test Report'''.
|Finalize and approve QC tests
 
|No
The report can include:
|Yes
 
|-
*Product
|Generate Certificate of Analysis or OOS reports
*Batch / lot
|No
*QC specification
|Yes
*Analytical results
|-
*Failed parameters
|View LabQC Pro audit trail
*Acceptance criteria
|Yes
*Final FAIL / OOS verdict
|Yes
*Analyst and approval information
|}
 
The report can be used as the starting point for further investigation or deviation management.


[[File:Certificates-reports.png|800x800px]]
These are suggested role settings. Adjust actual Dolibarr permissions to match organizational responsibilities and review group-inherited rights.


==Audit Trail==
==Optional integrations==


LabQC Pro records important quality-control events.
===BatchSafe Pro===


Audit Trail entries can include:
When BatchSafe Pro is installed and enabled, QC events can influence the batch/lot quality status, subject to the configured workflow and safeguards.
 
*User
*Date and time
*Object
*Event / action
*Previous value
*New value
*Note
 
Typical recorded events include:
 
*QC test creation
*Result entry or modification
*Status changes
*PASS / FAIL evaluation
*Finalization
 
This provides traceability of important laboratory actions and supports internal review and audit activities.
 
[[File:Labqcpro-audit-trail.png|800x800px]]
 
==BatchSafe Pro integration==
 
When '''BatchSafe Pro''' is installed and enabled, LabQC Pro can synchronize QC decisions with lot operational status.
 
Typical workflow:


{| class="wikitable"
{| class="wikitable"
!LabQC event
!LabQC event
!BatchSafe status
!Typical BatchSafe outcome
|-
|-
|New QC test opened
|New QC test opened
Line 248: Line 215:
|-
|-
|Finalized PASS
|Finalized PASS
|Released
|Released, where no higher-priority hold or restriction prevents release
|-
|-
|Finalized FAIL / OOS
|Finalized FAIL / OOS
Line 254: Line 221:
|}
|}


This allows laboratory quality decisions to influence warehouse lot availability automatically.
'''Important:''' an existing manual hold, recall or rejection is not automatically cancelled by a later PASS result. The current lot status may therefore reflect another QC test or a manually imposed restriction.
 
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.
 
[[File:Batchsafe-labqc-pro-integration.png|800x800px]]
 
==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.
===CAPA & Deviation Manager===


LabQC Pro continues to work independently when CAPA & Deviation Manager is not installed.
A finalized FAIL / OOS result can initiate a linked deviation. The prefilled deviation can include the QC test reference, product, batch/lot and specification details. After a deviation is created, the QC test provides a link to the existing record.


[[File:Capa-deviation-integration.png|800x800px]]
Both integrations are optional; LabQC Pro can run independently.


==Product and lot traceability==
==Installation and configuration==


QC tests can be linked to real Dolibarr products and lot / serial records.
===Requirements===


This helps maintain traceability between:
*Dolibarr V18–V24 (range declared on the DoliStore listing)
*PHP 7.4 or later (minimum declared on the DoliStore listing)
*Dolibarr Products and Stock modules
*Lot/Serial management for batch-based QC workflows


*Product
''The main functional validation of version 1.1.0 was performed on Dolibarr 24. Earlier supported versions and all hosting combinations were not comprehensively retested during this release.''
*Batch / lot
*QC specification
*Analytical results
*Final QC verdict
*BatchSafe status
*CAPA / deviation record when applicable


==Mobile support==
===New installation===


LabQC Pro includes a responsive interface suitable for desktop, tablet and smartphone use.
#Download the LabQC Pro ZIP package from DoliStore.
 
#In Dolibarr, open the setup area for modules/applications and external module installation.
The mobile interface supports:
#Upload the ZIP archive and enable LabQC Pro.
 
*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==
 
#Download the LabQC Pro module package.
#Go to '''Home → Setup → Modules/Applications''' in Dolibarr.
#Use the external module deployment / installation function.
#Upload the LabQC Pro ZIP package.
#Enable '''LabQC Pro'''.
#Configure user permissions.
#Configure user permissions.
#Make sure Products, Stock and Lot / Serial management are enabled when batch-based QC is required.
#Enable and configure product lot/serial management if batch-based QC is required.
 
#Create or select a product and define its QC specification and analytical parameters.
==Basic configuration==
#Create a QC test, enter results, review PASS / FAIL and finalize using an authorized account.
 
#Generate the corresponding CoA or OOS PDF report.
After activation:
 
#Create or select a product.
#Make sure the product uses lot / serial management when required.
#Create a QC Specification for the product.
#Add analytical parameters and acceptance criteria.
#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==
===Updating an existing installation===


Current documented version:
Version 1.1.0 retains module identifier '''207603''' and the established permission identifiers. Its declared database table definitions do not require a dedicated schema migration from the compared 1.0.43 package.


'''LabQC Pro 1.0.43'''
Before updating, back up the Dolibarr database and the existing module files, then deploy the new files following standard Dolibarr external-module procedures. Verify that existing specifications, tests, results, approvals, audit records and documents remain accessible.


==Languages==
''A direct end-to-end upgrade from the previously distributed 1.0.43 package to 1.1.0 on a populated installation was not performed as part of the final release checks. Test the upgrade on a backup or staging copy if your organization requires validated change control.''


LabQC Pro includes:
==Language support==


*English
*English
*Romanian
*Romanian


Additional translations can be added using the standard Dolibarr translation mechanism.
==Regulatory and quality notice==
 
==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'''
 
↓
 
'''PASS → CoA → BatchSafe Released'''
 
or
 
'''FAIL / OOS → OOS Report → BatchSafe Rejected → CAPA / Deviation'''
 
==Support==
 
Support and product information:
 
'''support@panciucsoft.com'''
 
LabQC Pro is developed by '''PanciucSoft'''.


==License==
LabQC Pro provides software functionality for laboratory quality-control workflows. It has not been independently certified as compliant with GMP, GLP, GxP, FDA 21 CFR Part 11 or other regulatory standards. Validation, qualification, procedural controls, electronic-signature requirements and regulatory compliance remain the responsibility of the organization implementing the module.


LabQC Pro is distributed under the '''GNU GPL v3 or later''' license.
==Support and license==


==Regulatory notice==
'''Developer:''' PanciucSoft


LabQC Pro provides software tools for laboratory quality-control workflows.
'''Support:''' [mailto:support@panciucsoft.com support@panciucsoft.com]


The module does not replace an organization's quality management system, standard operating procedures, validation activities, qualification activities or legally required controls.
'''License:''' GNU GPL v3 or later.


Validation, qualification and compliance with GMP, GLP, GxP, ISO or other regulatory requirements remain the responsibility of the organization using the module.
'''Version documented:''' LabQC Pro 1.1.0
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