Module LabQC Pro EN

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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.

It is intended for laboratories, manufacturers, pharmaceutical and food businesses, and other organizations that require traceable quality decisions for products and batches/lots.

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

LabQC Pro – Laboratory Quality Control Management for Dolibarr

Overview

LabQC Pro provides a structured workflow within Dolibarr:

QC Specification → QC Test → Analytical Results → Automatic PASS / FAIL → QC Manager Finalization → CoA / OOS Report

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

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

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

  • 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

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.

LabQC Pro 1.1.0 Dashboard

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.

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.

LabQC Pro specification details

Analytical parameters

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

Analytical parameter definitions and acceptance criteria

Example:

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

The values above are examples only; each organization must define and approve its own analytical methods and specifications.

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 Test creation and PASS / FAIL overview

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

Automatic evaluation

  • 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.

Users with analytical-result permissions can save results and recalculate the verdict while the QC test remains open.

Finalization, locking and deviation follow-up

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.

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.

Finalized QC test and linked CAPA deviation

Analytical results and traceability

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

QC analytical results and locked finalized record

Certificates of Analysis and OOS Reports

Reports are available for finalized QC tests:

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

The reports identify the product, batch/lot, QC specification, results and acceptance criteria, final decision and recorded approval information.

Certificate of Analysis and OOS report list

Sample PDF layouts

The following image illustrates the two PDF report types generated by LabQC Pro.

LabQC Pro CoA and OOS PDF examples

Recorded approval details are not represented as a certified cryptographic electronic signature.

Audit Trail

LabQC Pro records important actions associated with QC tests, including:

  • Creation of a QC test
  • 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 Audit Trail showing QC history and user actions

The application audit history supports traceability. Organizations remain responsible for database access controls, backups, retention and any applicable compliance validation.

User permissions and recommended roles

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

Permission Laboratory Analyst (example) 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.

Optional integrations

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.

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.

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.

Both integrations are optional; LabQC Pro can run independently.

Installation and configuration

Requirements

  • 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

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.

New installation

  1. Download the LabQC Pro ZIP package from DoliStore.
  2. In Dolibarr, open the setup area for modules/applications and external module installation.
  3. Upload the ZIP archive and enable LabQC Pro.
  4. Configure user permissions.
  5. Enable and configure product lot/serial management if batch-based QC is required.
  6. Create or select a product and define its QC specification and analytical parameters.
  7. Create a QC test, enter results, review PASS / FAIL and finalize using an authorized account.
  8. Generate the corresponding CoA or OOS PDF report.

Updating an existing installation

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.

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.

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.

Language support

  • English
  • Romanian

Regulatory and quality notice

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 and license

Developer: PanciucSoft

Support: support@panciucsoft.com

License: GNU GPL v3 or later.

Version documented: LabQC Pro 1.1.0