Computer System Validation (CSV) Audit
Our Computer System Validation (CSV) Audit Services at Apotech Consulting are tailored to ensure that computerised systems are compliant with relevant regulatory standards and industry best practices.
Through our range of services, our team can meticulously assess the accuracy, consistency and repeatability of systems, ensuring they perform as intended in a controlled and predictable manner. This involves comprehensively evaluating system life cycle documentation, validation plans, testing protocols and data integrity measures.
Trusted by top-tier teams worldwide
Our Computer System Validation auditing services include:
- Software suppliers
- Electronic records and signatures
- Infrastructure & IT service providers
- Statistics and programming
- GxP-related systems
- Internal process
Our Global Reach
We take pride in our extensive global audit network and are committed to utilising local auditors based in-country.
This approach offers several key benefits: local auditors possess in-depth knowledge of regional regulations, communicate effectively in the local language, and help reduce travel expenses for our clients. We have successfully provided support in all the regions highlighted on the map below.
FAQs on Audits
We provide a modern approach to auditing that offers full transparency. We aim to make the process as simple to understand as possible and are always on hand to answer any questions you might have.
Here are some of the questions we get asked most often.
Yes, our team can provide comprehensive CAPA (Corrective and Preventive Action) Management support.
Our modern and flexible approach ensures effective handling of CAPA processes, helping not only address and prevent any non-conformities but also contribute towards the continual improvement of both quality and compliance.
Featured case studies
Medical device CSV
Medical device CSV Introduction IVD manufacturer The client is an IVD manufacturer based in Europe. Although already ISO 13485:2016 certified, they were agnostic when it came to GAMP 5 and 21 CFR PART 11. They have 80 employees based over 2 sites in France. Apotech consultant: Apotech’s consultant coordinated 5 technicians, acting as project manager…