Computerized Systems Validation (CSV): planning, execution and quality assurance

The client, an internationally renowned biopharmaceutical company, develops and produces innovative virus-based gene therapy products.

End users of the products are clinics, but also private customers.

Customer

FinVector Oy

Branch

Medical

Project

Computerised Systems Validation

01

The challenge

FinVector Oy previously produced the adenovirus for research purposes only. In future, however, the commercial production of the virus should be possible instead.

Mandatory for this: the approval of the production processes by the US authority FDA (Food and Drug Administration), which is responsible, among other things, for the approval, control and monitoring of medical products in the USA.

02

The solution

In order to gain FDA approval and be able to distribute the new adenovirus-based products in the U.S., Computerized Systems Validation (CSV) had to be performed in accordance with GAMP 5.

In addition, the client required transparent documentation of all validation processes and results. Also, the open points and the handling of them had to be presented transparently.

03

The result

The CSV establishes whether a computerized system actually executes its processes as they are intended.

Exercim wrote the relevant procedures for validation and then carried them out for all computer-controlled production equipment. We were also responsible for prior planning and quality assurance.

The successful completion of the project: the declaration of the production permit by the FDA!

Exercim. Let's build something great together.

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