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{{DISPLAYTITLE:Module LabQC Pro}}
{{DISPLAYTITLE:Module LabQC Pro}}


=LabQC Pro=
'''LabQC Pro''' is a quality-control module for Dolibarr that manages product-specific analytical specifications, QC tests linked to batches/lots, inspection and sampling information, automatic PASS/FAIL evaluation, finalization, audit history and controlled PDF reporting.


'''LabQC Pro''' is a laboratory quality control module for Dolibarr.
The module is intended for laboratories, manufacturers and organizations performing incoming-goods, in-process or pre-shipment quality inspections. It can operate independently or with optional '''BatchSafe Pro''' and '''CAPA & Deviation Manager''' integrations.


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.
'''Current version: 1.1.1'''


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 – Quality Control Management for Dolibarr]]
 
The module can operate independently or integrate with '''BatchSafe Pro''' and '''CAPA & Deviation Manager'''.
 
[[File:Labqcpro-cover.png|800x800px]]


==Overview==
==Overview==


LabQC Pro adds a complete laboratory quality-control workflow to Dolibarr.
'''Typical workflow:'''


Typical workflow:
QC Specification → QC Test → Inspection Details → Analytical Results → Automatic PASS/FAIL → Finalization and Locking → CoA or OOS Report


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


Main capabilities include:
*Product-specific QC specifications and version references
*Analytical methods, numeric limits, text criteria and mandatory parameters
*QC tests linked to existing Dolibarr products and batches/lots
*Batch quantity and inspected quantity fields
*Manually entered AQL value, inspection type and third-party reference
*Automatic PASS/FAIL evaluation of analytical results
*Role-based permissions and controlled finalization
*Read-only results and inspection information after finalization
*Audit Trail recording tracked changes, including old and new values
*Certificate of Analysis (CoA) for finalized PASS tests
*OOS / QC Test Report for finalized FAIL tests
*Optional BatchSafe Pro and CAPA & Deviation Manager integrations
*Responsive desktop and mobile layouts
*Interface and PDF translations in English, Romanian, French, German and Spanish


*Product-specific QC specifications
==What's new in version 1.1.1==
*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==
Version '''1.1.1''' extends QC tests with inspection and sampling information and adds three new languages.


QC Specifications define the quality requirements that a product must meet.
*'''Batch quantity (parts)''' — the total quantity of parts in the batch subject to inspection
*'''Quantity inspected (parts)''' — the number of parts actually checked, which may be lower than the batch quantity
*'''AQL value (manual)''' — an optional value recorded for inspection traceability
*'''Third-party reference''' — a manually entered supplier order, customer order or other external reference
*'''Inspection type''' — for example, incoming inspection or pre-shipment inspection
*Inspection fields included in the QC test record, Audit Trail changes and CoA/OOS PDFs
*Inspection information becomes read-only after test finalization
*French, German and Spanish translations, in addition to English and Romanian
*Improvements to multilingual PDF headings, special characters, page layout and footer


A specification can contain:
'''Important:''' Recording an AQL value does '''not''' automatically calculate an ISO 2859 sampling plan, sample size, acceptance number or AQL-based lot acceptance/rejection decision. LabQC Pro's automatic PASS/FAIL evaluation applies to the analytical criteria configured for the QC test.


*Product
==Dashboard==
*Specification reference
*Specification version
*Analytical parameters
*Test method
*Acceptance criteria
*Units
*Mandatory / optional parameter status


Example:
The Dashboard presents counts for specifications, all QC tests, PASS tests, FAIL/OOS tests and tests in progress. It provides shortcuts for the main quality-control workflow.


{| class="wikitable"
[[File:01_Dashboard.png|600px|center|LabQC Pro dashboard and QC workflow]]
!Parameter
!Method
!Acceptance criteria
!Mandatory
|-
|Assay
|HPLC
|98–102 %
|Yes
|-
|Appearance
|Visual
|White tablets
|Yes
|}


Specifications can be versioned so that the quality requirements used for a QC test remain identifiable and traceable.
==QC Specifications==


[[File:Labqcpro-qc-specifications.png|800x800px]]
A QC specification defines the analytical requirements for a Dolibarr product. Each specification has a reference, label, version and status, and can contain multiple analytical parameters.


==QC Tests==
[[File:02_QC_Specifications.png|600px|center|QC specifications overview]]


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


Typical QC Test information includes:
The specification record identifies the product and version to which the analytical acceptance criteria apply.


*QC test reference
[[File:03_Specification_Details.png|600px|center|QC specification record]]
*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.
===Analytical parameters===


==Analytical results==
Each parameter can define the name, method, criterion type, acceptance limits or target text, unit and mandatory status.


Analytical results can be entered for each QC parameter.
[[File:04_Analytical_Parameters.png|600px|center|Analytical parameters and acceptance criteria]]


Depending on the parameter configuration, LabQC Pro can support:
Example (illustrative values only):


*Numeric results
{| class="wikitable"
*Text-based results
!Parameter
*Acceptance limits
!Method
*Required parameters
!Acceptance criterion
*Individual PASS / FAIL evaluation
!Mandatory
|-
|Assay||HPLC||98–102 %||Yes
|-
|Appearance||Visual||White tablets||Yes
|-
|pH||Potentiometric||5–7||Yes
|}


The result screen clearly displays the measured value, acceptance criteria and parameter verdict.
The organization must establish, approve and maintain the methods and criteria applicable to its products.


==Automatic PASS / FAIL evaluation==
==QC Tests==
 
LabQC Pro automatically evaluates QC results against the configured specification.
 
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
 
Automatic evaluation reduces manual verdict entry and helps keep laboratory decisions consistent with the active specification.
 
[[File:labqcpro-qc-tests-pass-fail.png|800x800px]]


==Finalization and locking==
QC tests are linked to a product, its QC specification and an existing Dolibarr batch/lot. A QC test may also contain a reference, test date and notes.


QC results remain editable while the test is open.
[[File:05_QC_Tests.png|600px|center|QC test creation and test list]]


After review, an authorized QC Manager can finalize the test.
===Inspection details (new in 1.1.1)===


Finalization:
The QC Test form and record include the following optional inspection fields:
 
*Records the final QC verdict
*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.
 
==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
 
===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==
 
Finalized PASS tests can generate a '''Certificate of Analysis (CoA)'''.
 
The report can include:
 
*Product
*Batch / lot
*QC specification
*Specification version
*Analytical parameters
*Results
*Acceptance criteria
*Individual verdicts
*Overall PASS verdict
*Tested by
*Approved by
*Approval date
 
The CoA provides a structured summary of the finalized laboratory decision.
 
==OOS / QC Test Report==
 
Finalized FAIL tests can generate an '''OOS / QC Test Report'''.
 
The report can include:
 
*Product
*Batch / lot
*QC specification
*Analytical results
*Failed parameters
*Acceptance criteria
*Final FAIL / OOS verdict
*Analyst and approval information
 
The report can be used as the starting point for further investigation or deviation management.
 
[[File:Certificates-reports.png|800x800px]]
 
==Audit Trail==
 
LabQC Pro records important quality-control events.
 
Audit Trail entries can include:
 
*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
!Field
!BatchSafe status
!Purpose
!Example
|-
|-
|New QC test opened
|'''Batch quantity (parts)'''||Total number of parts in the inspected batch||5000
|Under inspection
|-
|-
|Finalized PASS
|'''Quantity inspected (parts)'''||Actual number of inspected parts||100
|Released
|-
|-
|Finalized FAIL / OOS
|'''AQL value (manual)'''||Records the AQL value selected before inspection||0.65
|Rejected
|-
|'''Third-party reference'''||Supplier/customer order or other external identifier||PO-2026-00125
|-
|'''Inspection type'''||Context of inspection||Incoming inspection
|}
|}


This allows laboratory quality decisions to influence warehouse lot availability automatically.
The inspected quantity cannot exceed the batch quantity when both values are supplied. While a QC test remains open, authorized users can update inspection information; tracked changes are recorded in the Audit Trail. After finalization, these fields are displayed as read-only.


Existing manual critical holds can be preserved instead of being silently overwritten by automatic synchronization.
[[File:11_Inspection_Details.png|600px|center|LabQC Pro 1.1.1 inspection details with batch quantity, inspected quantity, AQL, third-party reference and inspection type]]


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.
'''AQL note:''' This field is for manual documentation only. AQL-based sampling-plan calculations and AQL acceptance/rejection decisions are not performed by the module.


BatchSafe Pro integration is optional.
===Analytical results and PASS/FAIL evaluation===


LabQC Pro continues to work independently when BatchSafe Pro is not installed or disabled.
For each analytical parameter, the user enters a numeric or text result as appropriate. LabQC Pro compares results with the applicable specification:


[[File:Batchsafe-labqc-pro-integration.png|800x800px]]
*'''PASS''' — the required results meet the configured acceptance criteria.
*'''FAIL / OOS''' — at least one required result is outside the configured criteria.
*'''Incomplete''' — required results are missing; the test cannot be finalized yet.


==CAPA & Deviation Manager integration==
[[File:07_Analytical_Results.png|600px|center|Analytical results and individual verdicts]]


Starting with LabQC Pro 1.0.43, finalized FAIL / OOS tests can be integrated with '''CAPA & Deviation Manager'''.
===Finalization and locking===


A linked deviation can be created directly from the QC test.
An authorized user with finalization rights reviews a completed QC test and finalizes the decision. Finalization records the responsible user and time and locks results and inspection details in the normal application workflow.


Typical workflow:
For finalized FAIL/OOS tests, an optional linked CAPA/deviation action can be available when CAPA & Deviation Manager is installed.


'''QC Test → FAIL / OOS → Finalization → Create CAPA / Deviation → Investigation → Corrective / Preventive Action'''
[[File:06_QC_Finalization_CAPA.png|600px|center|QC finalization and CAPA/deviation follow-up]]


The deviation form can be prefilled with information from the originating laboratory test, including:
==Certificates of Analysis and OOS Reports==


*Source module
LabQC Pro generates controlled PDF reports for finalized tests:
*QC test reference
*Product
*Batch / lot
*QC specification
*Severity
*Department
*Relevant QC context


Example source reference:
*'''Certificate of Analysis (CoA):''' finalized PASS tests
*'''OOS / QC Test Report:''' finalized FAIL tests


'''LabQC Pro · QCT-YYYYMMDD-HHMMSS'''
The reports show product and lot identification, selected QC specification, analytical results and verdicts, final decision, traceability and approval information. Starting with version 1.1.1, they also include inspection details when recorded.


This reduces duplicate data entry and keeps the deviation linked to the original laboratory result.
[[File:08_Certificates_OOS.png|600px|center|CoA and OOS report selection]]


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.
===CoA with inspection details (version 1.1.1)===


The deviation description remains readable and editable when opened or modified.
The following CoA example displays batch quantity, inspected quantity, manually entered AQL, third-party reference and inspection type together with analytical results and approval information.


CAPA & Deviation Manager integration is optional.
[[File:12_CoA_Inspection_Details.png|600px|center|Certificate of Analysis with inspection and sampling information in LabQC Pro 1.1.1]]


LabQC Pro continues to work independently when CAPA & Deviation Manager is not installed.
===CoA and OOS examples===


[[File:labqcpro-capa-deviation-integration.png|center|800px|LabQC Pro CAPA and deviation integration]]
[[File:10_CoA_OOS_PDF_Examples.png|600px|center|Examples of CoA and OOS PDF reports]]


==Product and lot traceability==
The approval information reflects the finalized QC record and does not represent a cryptographic electronic signature.


QC tests can be linked to real Dolibarr products and lot / serial records.
==Audit Trail==
 
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 records key QC events including test creation, analytical result modifications, inspection detail changes, status changes and finalization. Entries may include the timestamp, user, QC test, object, action, previous value, new value and note.


LabQC Pro includes a responsive interface suitable for desktop, tablet and smartphone use.
[[File:09_Audit_Trail.png|600px|center|Audit Trail showing recorded QC changes]]


The mobile interface supports:
The application Audit Trail supports traceability. Database permissions, backups, retention controls and regulatory validation remain the responsibility of the organization using the module.


*QC test review
==User roles and permissions==
*Analytical result entry
*PASS / FAIL visibility
*Finalization information
*Audit Trail access
*BatchSafe status display
*CAPA / deviation actions
*Responsive tables and result cards


==Installation==
Typical role assignments are:


#Download the LabQC Pro module package.
*'''Laboratory Analyst:''' create QC tests, enter and update results while open, review the automatic verdict.
#Go to '''Home → Setup → Modules/Applications''' in Dolibarr.
*'''QC Manager:''' review results, finalize/lock tests, review the Audit Trail and generate CoA/OOS reports.
#Use the external module deployment / installation function.
*'''Specification administrator/authorized QC user:''' maintain QC specifications and parameters according to local procedures.
#Upload the LabQC Pro ZIP package.
#Enable '''LabQC Pro'''.
#Configure user permissions.
#Make sure Products, Stock and Lot / Serial management are enabled when batch-based QC is required.


==Basic configuration==
Permissions must be configured in Dolibarr for the actual responsibilities and internal procedures of the organization.


After activation:
==Optional integrations==


#Create or select a product.
===BatchSafe Pro===
#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.
When BatchSafe Pro is enabled, QC outcomes can influence batch/lot quality status. Depending on the configuration and safeguards, a new test may put a lot under inspection, finalized PASS may support release and finalized FAIL/OOS may lead to rejection.


==Requirements==
Existing manual holds, recalls or restrictions must not be treated as automatically cleared merely because another QC test passes. The displayed lot state may also reflect a different QC test for the same lot.


*Dolibarr V18 to V23
BatchSafe Pro is optional; LabQC Pro works without it.
*PHP 7.4 or later
*Products module
*Stock / warehouse management
*Lot / Serial management for batch-based QC workflows


Optional:
===CAPA & Deviation Manager===


*'''BatchSafe Pro''' for lot-status synchronization
When the optional CAPA & Deviation Manager module is installed, a finalized FAIL/OOS test can be linked to a deviation record for investigation and follow-up. Relevant QC test, product, batch/lot and specification information can be used to prefill the deviation.
*'''CAPA & Deviation Manager''' for deviation and CAPA follow-up


==Version==
The integration is optional.
 
Current documented version:
 
'''LabQC Pro 1.0.43'''


==Languages==
==Languages==


LabQC Pro includes:
Version 1.1.1 provides interface and PDF translations in:


*English
*English (EN)
*Romanian
*Romanian (RO)
*French (FR)
*German (DE)
*Spanish (ES)


Additional translations can be added using the standard Dolibarr translation mechanism.
Names of products, analytical parameters and user-entered notes are stored as user data and are not automatically translated.


==Typical use cases==
==Requirements and compatibility==


LabQC Pro can be used in organizations such as:
*Dolibarr V18–V24 (declared product compatibility range)
*PHP 7.4 or later (declared minimum)
*Dolibarr Products and Stock modules
*Lot/Serial management for workflows that use existing batches/lots


*Laboratories
'''Compatibility note:''' The current functionality and the 1.1.1 multilingual PDF reports were tested on Dolibarr 24.0.0. Not every earlier declared Dolibarr release, hosting environment or upgrade scenario has been comprehensively retested.
*Pharmaceutical companies
*Food and supplement manufacturers
*Chemical manufacturers
*Manufacturing companies
*Quality-controlled warehouses
*Organizations using batch / lot-based product quality control


==Documentation workflow example==
==Installation and update==


A typical integrated workflow may look like:
===New installation===


'''Product / Lot'''
#Download the LabQC Pro ZIP package from DoliStore.
#Upload/deploy the external module through the Dolibarr module installation procedure.
#Enable LabQC Pro and configure the required user permissions.
#Ensure the necessary Products, Stock and Lot/Serial features are active.
#Create a QC Specification and its analytical parameters.
#Create a QC Test linked to a product and an existing batch/lot.
#Enter inspection details (optional) and analytical results.
#Review the calculated verdict, finalize with an authorized account and generate the CoA or OOS report.


↓
===Updating from an earlier version===


'''QC Specification'''
Back up the Dolibarr database and module files before deploying the new package. The module retains identifier '''207603'''. Existing QC tests without inspection details can remain without values in the new optional fields.


↓
After updating, verify existing specifications and tests, user rights, an open QC test and both report types. A staging upgrade is recommended for regulated or production environments.


'''QC Test'''
==Example use cases==


↓
*Incoming inspection of goods received from a supplier
*Production or batch laboratory quality control
*Pre-shipment inspection before delivery to a customer
*Laboratory tests with numeric and text acceptance criteria
*Documentation of lot quantity and inspected sample size
*Follow-up of out-of-specification results via an optional CAPA workflow


'''Analytical Results'''
==Support and license==


↓
'''Developer:''' PanciucSoft


'''Automatic PASS / FAIL'''
'''Support:''' [mailto:support@panciucsoft.com support@panciucsoft.com]


↓
'''Website:''' [https://panciucsoft.com panciucsoft.com]


'''QC Manager Finalization'''
'''License:''' GNU GPL v3 or later


↓
'''Current documented release:''' LabQC Pro 1.1.1
 
'''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 is distributed under the '''GNU GPL v3 or later''' license.


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


LabQC Pro provides software tools for laboratory quality-control workflows.
LabQC Pro provides tools to support laboratory and manufacturing quality-control workflows. The software has not been independently certified as compliant with GMP, GLP, GxP, FDA 21 CFR Part 11 or ISO 2859. Organizations are responsible for their system validation, standard operating procedures, electronic-signature controls where required, and applicable regulatory compliance.
 
The module does not replace an organization's quality management system, standard operating procedures, validation activities, qualification activities or legally required controls.
 
Validation, qualification and compliance with GMP, GLP, GxP, ISO or other regulatory requirements remain the responsibility of the organization using the module.

Latest revision as of 02:37, 30 October 2026


LabQC Pro is a quality-control module for Dolibarr that manages product-specific analytical specifications, QC tests linked to batches/lots, inspection and sampling information, automatic PASS/FAIL evaluation, finalization, audit history and controlled PDF reporting.

The module is intended for laboratories, manufacturers and organizations performing incoming-goods, in-process or pre-shipment quality inspections. It can operate independently or with optional BatchSafe Pro and CAPA & Deviation Manager integrations.

Current version: 1.1.1

LabQC Pro – Quality Control Management for Dolibarr

Overview

Typical workflow:

QC Specification → QC Test → Inspection Details → Analytical Results → Automatic PASS/FAIL → Finalization and Locking → CoA or OOS Report

Main features

  • Product-specific QC specifications and version references
  • Analytical methods, numeric limits, text criteria and mandatory parameters
  • QC tests linked to existing Dolibarr products and batches/lots
  • Batch quantity and inspected quantity fields
  • Manually entered AQL value, inspection type and third-party reference
  • Automatic PASS/FAIL evaluation of analytical results
  • Role-based permissions and controlled finalization
  • Read-only results and inspection information after finalization
  • Audit Trail recording tracked changes, including old and new values
  • Certificate of Analysis (CoA) for finalized PASS tests
  • OOS / QC Test Report for finalized FAIL tests
  • Optional BatchSafe Pro and CAPA & Deviation Manager integrations
  • Responsive desktop and mobile layouts
  • Interface and PDF translations in English, Romanian, French, German and Spanish

What's new in version 1.1.1

Version 1.1.1 extends QC tests with inspection and sampling information and adds three new languages.

  • Batch quantity (parts) — the total quantity of parts in the batch subject to inspection
  • Quantity inspected (parts) — the number of parts actually checked, which may be lower than the batch quantity
  • AQL value (manual) — an optional value recorded for inspection traceability
  • Third-party reference — a manually entered supplier order, customer order or other external reference
  • Inspection type — for example, incoming inspection or pre-shipment inspection
  • Inspection fields included in the QC test record, Audit Trail changes and CoA/OOS PDFs
  • Inspection information becomes read-only after test finalization
  • French, German and Spanish translations, in addition to English and Romanian
  • Improvements to multilingual PDF headings, special characters, page layout and footer

Important: Recording an AQL value does not automatically calculate an ISO 2859 sampling plan, sample size, acceptance number or AQL-based lot acceptance/rejection decision. LabQC Pro's automatic PASS/FAIL evaluation applies to the analytical criteria configured for the QC test.

Dashboard

The Dashboard presents counts for specifications, all QC tests, PASS tests, FAIL/OOS tests and tests in progress. It provides shortcuts for the main quality-control workflow.

LabQC Pro dashboard and QC workflow

QC Specifications

A QC specification defines the analytical requirements for a Dolibarr product. Each specification has a reference, label, version and status, and can contain multiple analytical parameters.

QC specifications overview

Specification details

The specification record identifies the product and version to which the analytical acceptance criteria apply.

QC specification record

Analytical parameters

Each parameter can define the name, method, criterion type, acceptance limits or target text, unit and mandatory status.

Analytical parameters and acceptance criteria

Example (illustrative values only):

Parameter Method Acceptance criterion Mandatory
Assay HPLC 98–102 % Yes
Appearance Visual White tablets Yes
pH Potentiometric 5–7 Yes

The organization must establish, approve and maintain the methods and criteria applicable to its products.

QC Tests

QC tests are linked to a product, its QC specification and an existing Dolibarr batch/lot. A QC test may also contain a reference, test date and notes.

QC test creation and test list

Inspection details (new in 1.1.1)

The QC Test form and record include the following optional inspection fields:

Field Purpose Example
Batch quantity (parts) Total number of parts in the inspected batch 5000
Quantity inspected (parts) Actual number of inspected parts 100
AQL value (manual) Records the AQL value selected before inspection 0.65
Third-party reference Supplier/customer order or other external identifier PO-2026-00125
Inspection type Context of inspection Incoming inspection

The inspected quantity cannot exceed the batch quantity when both values are supplied. While a QC test remains open, authorized users can update inspection information; tracked changes are recorded in the Audit Trail. After finalization, these fields are displayed as read-only.

LabQC Pro 1.1.1 inspection details with batch quantity, inspected quantity, AQL, third-party reference and inspection type

AQL note: This field is for manual documentation only. AQL-based sampling-plan calculations and AQL acceptance/rejection decisions are not performed by the module.

Analytical results and PASS/FAIL evaluation

For each analytical parameter, the user enters a numeric or text result as appropriate. LabQC Pro compares results with the applicable specification:

  • PASS — the required results meet the configured acceptance criteria.
  • FAIL / OOS — at least one required result is outside the configured criteria.
  • Incomplete — required results are missing; the test cannot be finalized yet.
Analytical results and individual verdicts

Finalization and locking

An authorized user with finalization rights reviews a completed QC test and finalizes the decision. Finalization records the responsible user and time and locks results and inspection details in the normal application workflow.

For finalized FAIL/OOS tests, an optional linked CAPA/deviation action can be available when CAPA & Deviation Manager is installed.

QC finalization and CAPA/deviation follow-up

Certificates of Analysis and OOS Reports

LabQC Pro generates controlled PDF reports for finalized tests:

  • Certificate of Analysis (CoA): finalized PASS tests
  • OOS / QC Test Report: finalized FAIL tests

The reports show product and lot identification, selected QC specification, analytical results and verdicts, final decision, traceability and approval information. Starting with version 1.1.1, they also include inspection details when recorded.

CoA and OOS report selection

CoA with inspection details (version 1.1.1)

The following CoA example displays batch quantity, inspected quantity, manually entered AQL, third-party reference and inspection type together with analytical results and approval information.

Certificate of Analysis with inspection and sampling information in LabQC Pro 1.1.1

CoA and OOS examples

Examples of CoA and OOS PDF reports

The approval information reflects the finalized QC record and does not represent a cryptographic electronic signature.

Audit Trail

LabQC Pro records key QC events including test creation, analytical result modifications, inspection detail changes, status changes and finalization. Entries may include the timestamp, user, QC test, object, action, previous value, new value and note.

Audit Trail showing recorded QC changes

The application Audit Trail supports traceability. Database permissions, backups, retention controls and regulatory validation remain the responsibility of the organization using the module.

User roles and permissions

Typical role assignments are:

  • Laboratory Analyst: create QC tests, enter and update results while open, review the automatic verdict.
  • QC Manager: review results, finalize/lock tests, review the Audit Trail and generate CoA/OOS reports.
  • Specification administrator/authorized QC user: maintain QC specifications and parameters according to local procedures.

Permissions must be configured in Dolibarr for the actual responsibilities and internal procedures of the organization.

Optional integrations

BatchSafe Pro

When BatchSafe Pro is enabled, QC outcomes can influence batch/lot quality status. Depending on the configuration and safeguards, a new test may put a lot under inspection, finalized PASS may support release and finalized FAIL/OOS may lead to rejection.

Existing manual holds, recalls or restrictions must not be treated as automatically cleared merely because another QC test passes. The displayed lot state may also reflect a different QC test for the same lot.

BatchSafe Pro is optional; LabQC Pro works without it.

CAPA & Deviation Manager

When the optional CAPA & Deviation Manager module is installed, a finalized FAIL/OOS test can be linked to a deviation record for investigation and follow-up. Relevant QC test, product, batch/lot and specification information can be used to prefill the deviation.

The integration is optional.

Languages

Version 1.1.1 provides interface and PDF translations in:

  • English (EN)
  • Romanian (RO)
  • French (FR)
  • German (DE)
  • Spanish (ES)

Names of products, analytical parameters and user-entered notes are stored as user data and are not automatically translated.

Requirements and compatibility

  • Dolibarr V18–V24 (declared product compatibility range)
  • PHP 7.4 or later (declared minimum)
  • Dolibarr Products and Stock modules
  • Lot/Serial management for workflows that use existing batches/lots

Compatibility note: The current functionality and the 1.1.1 multilingual PDF reports were tested on Dolibarr 24.0.0. Not every earlier declared Dolibarr release, hosting environment or upgrade scenario has been comprehensively retested.

Installation and update

New installation

  1. Download the LabQC Pro ZIP package from DoliStore.
  2. Upload/deploy the external module through the Dolibarr module installation procedure.
  3. Enable LabQC Pro and configure the required user permissions.
  4. Ensure the necessary Products, Stock and Lot/Serial features are active.
  5. Create a QC Specification and its analytical parameters.
  6. Create a QC Test linked to a product and an existing batch/lot.
  7. Enter inspection details (optional) and analytical results.
  8. Review the calculated verdict, finalize with an authorized account and generate the CoA or OOS report.

Updating from an earlier version

Back up the Dolibarr database and module files before deploying the new package. The module retains identifier 207603. Existing QC tests without inspection details can remain without values in the new optional fields.

After updating, verify existing specifications and tests, user rights, an open QC test and both report types. A staging upgrade is recommended for regulated or production environments.

Example use cases

  • Incoming inspection of goods received from a supplier
  • Production or batch laboratory quality control
  • Pre-shipment inspection before delivery to a customer
  • Laboratory tests with numeric and text acceptance criteria
  • Documentation of lot quantity and inspected sample size
  • Follow-up of out-of-specification results via an optional CAPA workflow

Support and license

Developer: PanciucSoft

Support: support@panciucsoft.com

Website: panciucsoft.com

License: GNU GPL v3 or later

Current documented release: LabQC Pro 1.1.1

Regulatory notice

LabQC Pro provides tools to support laboratory and manufacturing quality-control workflows. The software has not been independently certified as compliant with GMP, GLP, GxP, FDA 21 CFR Part 11 or ISO 2859. Organizations are responsible for their system validation, standard operating procedures, electronic-signature controls where required, and applicable regulatory compliance.

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