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Commissioning, Qualification and Validation.

Commissioning, Qualification and Validation.

The Commissioning, Qualification and Validation (CQV) department has been in operation since around the birth of CSV Life Science at the beginning of 2000s. After almost than 25 years of activity, it has become a strong and solid division, as well as a hallmark for anyone needing CQV services both in Italy and abroad.

CQV activities offered by Csv Life Science Group, in constant collaboration with the relevant figures within the manufacturing companies, are aimed at ensuring full compliance with all the necessary GMP requirements.

Commissioning, Qualification and Validation department can offer customers several services: from user requirements outline and validation Master Plans to factory and site acceptance tests (FAT&SAT tests); from Instruments calibration up to IQ, OQ, IOQ protocols writing; cleaning validation, change control services as well as supplier audits, risk assessment, training on rules and guidelines and so on.   

However, in addition to the wide range of services offered, the strength of the Commissioning, Qualification and Validation area of CSV Life Science can be seen in other aspects.

Customer-oriented validation.

CSV Life Science makes flexibility one of its strengths. This characteristic allows the Commissioning, Qualification and Validation division to face any new project by starting from customer’s needs and adapting the activities approach in relation to project requirements and specificities.

In practice, for more structured clients with a standardised and robust quality system, we are able to acquire the specific procedures and to model our output on what is already in place. A job that always looks to continuous improvement, both in technical and qualitative terms. On the other hand, for less structured clients, or those unfamiliar with projects of a certain size, we can offer an entire package including both templates and content.

This flexibility, which is appreciated by all our clients, is due to the solid experience CSV Life Science has gained over the years, especially in international projects.

Rapid answers for fast-changing times

The times we are living in confront us with new challenges. The first one is technological innovation, especially computerized systems, which are more and more used for all the equipment involved in the production of drugs and APIs. Over the years, this innovation has required adapting regulations and guidelines leading to continuous training and update of staff approach to validation activities.

The second challenge changing the field of validation is caused by the dynamics of the market, which today require ever-faster response times from production. A very current example is the urgent need to produce vaccines in response to the Covid-19 pandemic. In the last two years, the need to insert a huge quantity of drugs on the world market has become an evidence. To meet this demand, integration between the different stages of the QC process, combined with and supported by a risk-based approach (to focus quality efforts on truly critical aspects), has proved to be a key weapon.

CSV Life science, which has promoted an integrated approach since the early 2000s, through its Commissioning, Qualification and Validation division has been therefore ready and prepared, proposing solutions that meet particularly time-critical needs, in full compliance with GMP and data integrity requirements.

20 years and more of international experience and a large corporate network.

CSV Life Science Group can rely on almost 25 years-experience, enriched above all by working in international countries. This know-how translates into flexibility and strong technical expertise, making the whole Group and the commissioning, qualification and validation area of CSV Life Science an ideal partner for complex and different projects. The end customer is thus assured of finding the answer to all his needs, as well as great efficiency and accuracy.

The Group is the great added value to all services. The strong synergy that characterises CSV Life Science Group allows customers to have at their disposal not only the Commissioning, Qualification and Validation department, but also all the other divisions. For the commissioning, qualification and validation activities, in particular, the integration between the various souls of CSV is expressed in the close collaboration with the engineering department. A true company network, which ensures that end customers have a highly specialised staff with in-depth knowledge of the entire Life Science world.

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