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Under a high level of quality assurance and within a very strict regulatory framework, the pharmaceutical and medical industries must ensure and guarantee the safety, efficacy, and quality of products/services offered on the market are respected.

To achieve this goal, it is necessary to put in place a quality management system that combines best production practices and risk management within the organization.

Qualipro Logiciel Qualité

Having trouble keeping up with the equipment calibration and qualification schedule? Managing audits takes you a lot of time? Do you have trouble tracking deviations and changes?

It is essential to equip yourself with reliable document and process management tools to turn constraints into opportunities:

Qualipro is the solution that will allow you to optimize the management of your quality system through its various modules which meet the requirements of GMP, ISO 9001 as well as CFR PART 11 and NF EN ISO 13485.

Among the main features of Qualipro for quality management within medical or pharmaceutical organizations:


Manage risks and comply with regulatory requirements.


Identify deviations and non-conformities.

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Manage CAPA, corrective and preventive actions.

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Manage documentation, staff skills, and training schedules.


Automation of validation flows.

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Real-time monitoring of the implementation and effectiveness of the planned actions.

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Ensure the management and qualification of equipment and instruments.


Have real-time performance indicators.

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Automatic generation of dashboards.


Collaborative supplier planning and monitoring.


Management of change requests (Change Control).

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Gérer les réclamations, ainsi que la mesure de la satisfaction.

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Customer management through the processing of complaints, as well as the measurement of satisfaction.

QUALIPRO: compliant with FDA 21 CFR Part 11 regulatory requirements

All companies in the pharmaceutical, cosmetic, and food industries must meet the requirements of 21 CFR Part 11 to market their products in the United States.

The 21 CFR Part 11 regulation requires organizations regulated by the FDA (Food and Drug Administration) using electronic records and signatures to set up and certify controls that aim to guarantee the authenticity, reliability, and validity of software and systems for processing their digital data to avoid any sale of non-compliant products, which could have serious health consequences.