For the verification and validation of software products in the pharmaceutical industry, EXCO provides customers with specialist teams of highly trained employees. These teams reliably implement the quality system requirements of ISO 13485 and 9001, FDA QSR, ICH Q7a, or the EU GMP guidelines.

Global market leaders in the pharmaceutical industry place their trust in EXCO's verification and validation processes, both for their own developments and for those of third parties. We help increase the efficiency and quality of software. This removes the burden from the R&D departments of our medical technology and Pharmaceutical customers and minimises costs and risks.

Benefit from the experience that our employees have gathered in the course of many hundreds of projects relating to quality assurance consultancy and the implementation of quality assurance measures. Specifically, we take on the following tasks as consultants or verification/validation managers:

• Coordination and project management tasks
• Cost monitoring
• Deadline monitoring
• Creation of test equipment for verification purposes (HW, SW such as needle adapters, test tools, etc.)
• Reviews of functional and requirement specifications, technical design
• Source code reviews
• Creation and review of test specifications
• Creation and review of test reports
• Moderation of issue meetings
• Validation of test tools and Excel applications
• Support with the creation of a traceability matrix
• Creation, updating, and checking of traces in Requisite Pro
• Creation of test definitions
• Documentation of deviations using Clear Quest
• Documentation of test results using Requisite Pro
• Creation/revision of templates
• Material procurement (HW, SW, etc.)
• Creation of project progress reports
• Creation of product accreditation documentation for medical devices for the filing of applications with notified bodies in Europe (IVD Directive, CE Label) and the US (FDA 510 k)
• Planning and execution of training courses