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Updated LabQC Pro documentation to v1.1.1: batch inspection quantities, manual AQL, third-party references, five languages, multilingual PDF reports 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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(Updated LabQC Pro documentation to v1.1.1: batch inspection quantities, manual AQL, third-party references, five languages, multilingual PDF reports and new screenshots.)
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{{DISPLAYTITLE:Module 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=


It is intended for laboratories, manufacturers, pharmaceutical and food businesses, and other organizations that require traceable quality decisions for products and batches/lots.
'''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 can be used independently or with optional '''BatchSafe Pro''' and '''CAPA & Deviation Manager''' integrations.
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.


[[File:00_Cover_LabQC_Pro.png|600px|center|LabQC Pro – Laboratory Quality Control Management for Dolibarr]]
'''Current version: 1.1.1'''
 
[[File:00_Cover_LabQC_Pro.png|600px|center|LabQC Pro – Quality Control Management for Dolibarr]]


==Overview==
==Overview==


LabQC Pro provides a structured workflow within Dolibarr:
'''Typical workflow:'''


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


If optional integrations are enabled, finalized QC outcomes can also support batch-status management and CAPA/deviation follow-up.
===Main features===


===Key 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


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


Version '''1.1.0''' is a major interface, workflow and reliability update.
*'''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


*Redesigned Dashboard with QC statistics and workflow shortcuts
'''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.
*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


===Dashboard===
==Dashboard==


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.
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 1.1.0 Dashboard]]
[[File:01_Dashboard.png|600px|center|LabQC Pro dashboard and QC workflow]]


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


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


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


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


===Analytical parameters===
===Analytical parameters===


Analytical parameters define the method, criterion type, minimum and maximum limits or required text, measurement unit and mandatory/optional status.
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 parameter definitions and acceptance criteria]]
[[File:04_Analytical_Parameters.png|600px|center|Analytical parameters and acceptance criteria]]


Example:
Example (illustrative values only):


{| class="wikitable"
{| class="wikitable"
Line 79: Line 82:
!Mandatory
!Mandatory
|-
|-
|Assay
|Assay||HPLC||98–102 %||Yes
|HPLC
|98–102 %
|Yes
|-
|-
|Appearance
|Appearance||Visual||White tablets||Yes
|Visual
|White tablets
|Yes
|-
|-
|pH
|pH||Potentiometric||5–7||Yes
|Potentiometric
|5–7 pH
|Yes
|}
|}


''The values above are examples only; each organization must define and approve its own analytical methods and specifications.''
The organization must establish, approve and maintain the methods and criteria applicable to its products.


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


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.
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:


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


A QC test can hold multiple analytical results. Each result is evaluated against its applicable acceptance criterion.
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.


===Automatic evaluation===
[[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]]


*'''PASS:''' the required analytical results satisfy the selected criteria.
'''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.
*'''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.


Users with analytical-result permissions can save results and recalculate the verdict while the QC test remains open.
===Analytical results and PASS/FAIL evaluation===


===Finalization, locking and deviation follow-up===
For each analytical parameter, the user enters a numeric or text result as appropriate. LabQC Pro compares results with the applicable specification:


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.
*'''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.


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.
[[File:07_Analytical_Results.png|600px|center|Analytical results and individual verdicts]]


[[File:06_QC_Finalization_CAPA.png|600px|center|Finalized QC test and linked CAPA deviation]]
===Finalization and locking===


===Analytical results and traceability===
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.


The detailed QC test screen presents each analytical parameter, method, specification, measured result and PASS / FAIL verdict. Finalized records are displayed as read-only.
For finalized FAIL/OOS tests, an optional linked CAPA/deviation action can be available when CAPA & Deviation Manager is installed.


[[File:07_Analytical_Results.png|600px|center|QC analytical results and locked finalized record]]
[[File:06_QC_Finalization_CAPA.png|600px|center|QC finalization and CAPA/deviation follow-up]]


==Certificates of Analysis and OOS Reports==
==Certificates of Analysis and OOS Reports==


Reports are available for finalized QC tests:
LabQC Pro generates controlled PDF reports for finalized tests:


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


The reports identify the product, batch/lot, QC specification, results and acceptance criteria, final decision and recorded approval information.
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|Certificate of Analysis and OOS report list]]
[[File:08_Certificates_OOS.png|600px|center|CoA and OOS report selection]]


===Sample PDF layouts===
===CoA with inspection details (version 1.1.1)===


The following image illustrates the two PDF report types generated by LabQC Pro.
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:10_CoA_OOS_PDF_Examples.png|600px|center|LabQC Pro CoA and OOS PDF examples]]
[[File:12_CoA_Inspection_Details.png|600px|center|Certificate of Analysis with inspection and sampling information in LabQC Pro 1.1.1]]


''Recorded approval details are not represented as a certified cryptographic electronic signature.''
===CoA and OOS examples===


==Audit Trail==
[[File:10_CoA_OOS_PDF_Examples.png|600px|center|Examples of CoA and OOS PDF reports]]


LabQC Pro records important actions associated with QC tests, including:
The approval information reflects the finalized QC record and does not represent a cryptographic electronic signature.


*Creation of a QC test
==Audit Trail==
*Entry or modification of analytical results
*Recalculation of the QC test status
*Finalization and locking


The audit history displays event time, QC test, action, related object, user, previous value, new value and a note where applicable.
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|LabQC Pro Audit Trail showing QC history and user actions]]
[[File:09_Audit_Trail.png|600px|center|Audit Trail showing recorded QC changes]]


The application audit history supports traceability. Organizations remain responsible for database access controls, backups, retention and any applicable compliance validation.
The application Audit Trail supports traceability. Database permissions, backups, retention controls and regulatory validation remain the responsibility of the organization using the module.


==User permissions and recommended roles==
==User roles and permissions==


LabQC Pro provides separate permissions for reading QC information, managing specifications, creating tests, entering results, finalization, reporting and Audit Trail access.
Typical role assignments are:


{| class="wikitable"
*'''Laboratory Analyst:''' create QC tests, enter and update results while open, review the automatic verdict.
!Permission
*'''QC Manager:''' review results, finalize/lock tests, review the Audit Trail and generate CoA/OOS reports.
!Laboratory Analyst (example)
*'''Specification administrator/authorized QC user:''' maintain QC specifications and parameters according to local procedures.
!QC Manager (example)
|-
|Read LabQC Pro quality control data
|Yes
|Yes
|-
|Create or modify QC specifications and analytical parameters
|No
|No
|-
|Create QC tests
|Yes
|No
|-
|Enter or modify analytical results
|Yes
|No
|-
|Finalize and approve QC tests
|No
|Yes
|-
|Generate Certificate of Analysis or OOS reports
|No
|Yes
|-
|View LabQC Pro audit trail
|Yes
|Yes
|}


These are suggested role settings. Adjust actual Dolibarr permissions to match organizational responsibilities and review group-inherited rights.
Permissions must be configured in Dolibarr for the actual responsibilities and internal procedures of the organization.


==Optional integrations==
==Optional integrations==
Line 205: Line 186:
===BatchSafe Pro===
===BatchSafe Pro===


When BatchSafe Pro is installed and enabled, QC events can influence the batch/lot quality status, subject to the configured workflow and safeguards.
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.


{| class="wikitable"
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.
!LabQC event
!Typical BatchSafe outcome
|-
|New QC test opened
|Under inspection
|-
|Finalized PASS
|Released, where no higher-priority hold or restriction prevents release
|-
|Finalized FAIL / OOS
|Rejected
|}


'''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.
BatchSafe Pro is optional; LabQC Pro works without it.


===CAPA & Deviation Manager===
===CAPA & Deviation Manager===


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.
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.


Both integrations are optional; LabQC Pro can run independently.
The integration is optional.


==Installation and configuration==
==Languages==


===Requirements===
Version 1.1.1 provides interface and PDF translations in:


*Dolibarr V18–V24 (range declared on the DoliStore listing)
*English (EN)
*PHP 7.4 or later (minimum declared on the DoliStore listing)
*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
*Dolibarr Products and Stock modules
*Lot/Serial management for batch-based QC workflows
*Lot/Serial management for workflows that use existing batches/lots


''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.''
'''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===
===New installation===


#Download the LabQC Pro ZIP package from DoliStore.
#Download the LabQC Pro ZIP package from DoliStore.
#In Dolibarr, open the setup area for modules/applications and external module installation.
#Upload/deploy the external module through the Dolibarr module installation procedure.
#Upload the ZIP archive and enable LabQC Pro.
#Enable LabQC Pro and configure the required user permissions.
#Configure user permissions.
#Ensure the necessary Products, Stock and Lot/Serial features are active.
#Enable and configure product lot/serial management if batch-based QC is required.
#Create a QC Specification and its analytical parameters.
#Create or select a product and define its QC specification and analytical parameters.
#Create a QC Test linked to a product and an existing batch/lot.
#Create a QC test, enter results, review PASS / FAIL and finalize using an authorized account.
#Enter inspection details (optional) and analytical results.
#Generate the corresponding CoA or OOS PDF report.
#Review the calculated verdict, finalize with an authorized account and generate the CoA or OOS report.


===Updating an existing installation===
===Updating from an earlier 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.
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.


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.
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.


''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.''
==Example use cases==


==Language support==
*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


*English
==Support and license==
*Romanian


==Regulatory and quality notice==
'''Developer:''' PanciucSoft


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


==Support and license==
'''Website:''' [https://panciucsoft.com panciucsoft.com]


'''Developer:''' PanciucSoft
'''License:''' GNU GPL v3 or later


'''Support:''' [mailto:support@panciucsoft.com support@panciucsoft.com]
'''Current documented release:''' LabQC Pro 1.1.1


'''License:''' GNU GPL v3 or later.
==Regulatory notice==


'''Version documented:''' LabQC Pro 1.1.0
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.
Mikrosha2000
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