View source for Module LabQC Pro EN

{{DISPLAYTITLE:Module 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.

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'''

[[File:00_Cover_LabQC_Pro.png|600px|center|LabQC Pro – Quality Control Management for Dolibarr]]

==Overview==

'''Typical workflow:'''

QC Specification &rarr; QC Test &rarr; Inspection Details &rarr; Analytical Results &rarr; Automatic PASS/FAIL &rarr; Finalization and Locking &rarr; 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.

[[File:01_Dashboard.png|600px|center|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.

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

===Specification details===

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

[[File:03_Specification_Details.png|600px|center|QC specification record]]

===Analytical parameters===

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

[[File:04_Analytical_Parameters.png|600px|center|Analytical parameters and acceptance criteria]]

Example (illustrative values only):

{| class="wikitable"
!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.

[[File:05_QC_Tests.png|600px|center|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:

{| class="wikitable"
!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.

[[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]]

'''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.

[[File:07_Analytical_Results.png|600px|center|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.

[[File:06_QC_Finalization_CAPA.png|600px|center|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.

[[File:08_Certificates_OOS.png|600px|center|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.

[[File:12_CoA_Inspection_Details.png|600px|center|Certificate of Analysis with inspection and sampling information in LabQC Pro 1.1.1]]

===CoA and OOS examples===

[[File:10_CoA_OOS_PDF_Examples.png|600px|center|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.

[[File:09_Audit_Trail.png|600px|center|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===

#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===

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:''' [mailto:support@panciucsoft.com support@panciucsoft.com]

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