Beyond standards

As an integral part of the healthcare world, the medical device industry must comply with a dedicated regulatory framework to protect the patient and ensure health benefits. The different tasks of the AR department imply a central position in the internal and external interactions of the company. The manufacturing of a DM is organized according to a "Supply Chain". It includes the different departments of the company, whether technical, support or commercial, but also numerous suppliers and subcontractors. Since regulatory requirements apply to the entire manufacturing process, the RAs interact with all the players involved, particularly through regulatory audits.

The healthcare industry is constantly faced with product quality, hygiene, environmental and safety issues, as well as regulatory issues and business risks. Alispharm works with its clients to help them secure their industrial environment, from the design phase to the marketing of their products. The Qualification/Validation process takes on its full meaning in this industrial […]

For MD, you need a file that would follow the famous V-cycle and would contain the user requirements, the functional requirements, the risk analysis, the validation plan and the protocols and reports of Installation Qualification, Operational Qualification, Performance Qualification among others. First of all, everything is based on the classification of the medical device in question: I (and special I), IIa, IIb or III, which changes a lot!

Quality control generates a certain number of quality events such as OOX, deviations and other laboratory investigations. The delay between the opening and the closing of an event can take a certain time due to several factors.

Pharmaceutical and biotechnology regulatory affairs is a complex and ever-changing field, where non-compliance and non-compliance with requirements can result in severe penalties, fines and reputational damage.This poses many challenges to the pharmaceutical industry, which can be described in the different stages of the healthcare product life cycle: Strategic regulatory planning at the development stage Understanding […]

The healthcare industry is constantly faced with product quality, hygiene, environmental and safety issues, as well as regulatory issues and business risks. Alispharm works with its clients to help them secure their industrial environment, from the design phase to the marketing of their products. The Qualification/Validation process takes on its full meaning in this industrial […]

Physical-Chemical Quality Control (QC) is one of the central departments in the pharmaceutical industry. It ensures that the quality of incoming materials and outgoing products are of sufficient quality for their use or consumption.

Quality control generates a certain number of quality events such as OOX, deviations and other laboratory investigations. The delay between the opening and the closing of an event can take a certain time due to several factors.

The career path of a QV specialist.

Physical-Chemical Quality Control (QC) is one of the central departments in the pharmaceutical industry. It ensures that the quality of incoming materials and outgoing products are of sufficient quality for their use or consumption.

Quality control generates a certain number of quality events such as OOX, deviations and other laboratory investigations. The delay between the opening and the closing of an event can take a certain time due to several factors.

The healthcare industry is constantly faced with product quality, hygiene, environmental and safety issues, as well as regulatory issues and business risks. Alispharm works with its clients to help them secure their industrial environment, from the design phase to the marketing of their products. The Qualification/Validation process takes on its full meaning in this industrial […]

For MD, you need a file that would follow the famous V-cycle and would contain the user requirements, the functional requirements, the risk analysis, the validation plan and the protocols and reports of Installation Qualification, Operational Qualification, Performance Qualification among others. First of all, everything is based on the classification of the medical device in question: I (and special I), IIa, IIb or III, which changes a lot!

As an integral part of the healthcare world, the medical device industry must comply with a dedicated regulatory framework to protect the patient and ensure health benefits. The different tasks of the AR department imply a central position in the internal and external interactions of the company. The manufacturing of a DM is organized according to a "Supply Chain". It includes the different departments of the company, whether technical, support or commercial, but also numerous suppliers and subcontractors. Since regulatory requirements apply to the entire manufacturing process, the RAs interact with all the players involved, particularly through regulatory audits.

Pharmaceutical and biotechnology regulatory affairs is a complex and ever-changing field, where non-compliance and non-compliance with requirements can result in severe penalties, fines and reputational damage.This poses many challenges to the pharmaceutical industry, which can be described in the different stages of the healthcare product life cycle: Strategic regulatory planning at the development stage Understanding […]