Is any support provided during the system validation process?

Q: Is any support provided during the system validation process?

As a part of the startup service, we provide the Quick Start Validation Kit , a set of documents compliant with the GAMP5 guidelines, containing the Standard Market Requirements, the Quality and Project Plan, the Design Specifications, the Functional Specifications, the Regulatory Compliance, the Traceability Matrix, the Installation Procedures and the Unit and Integration Tests performed in our standard environment (OQ - Functional Testing). We provide also the System Configuration Specification (SCS) and consequently the Installation Qualification protocol (IQ). In addition, we are available to furnish our technical know-how to support the customer during the system validation process. To learn more, please read this article Simple validation with our help

As a part of the startup service, we provide the Quick Start Validation Kit, a set of documents compliant with the GAMP5 guidelines, containing the Standard Market Requirements, the Quality and Project Plan, the Design Specifications, the Functional Specifications, the Regulatory Compliance, the Traceability Matrix, the Installation Procedures and the Unit and Integration Tests performed in our standard environment (OQ – Functional Testing).
We provide also the System Configuration Specification (SCS) and consequently the Installation Qualification protocol (IQ).

In addition, we are available to furnish our technical know-how to support the customer during the system validation process.

To learn more, please read this article Simple validation with our help

Sonia Monni2022-12-07T13:07:34+01:0022 December 2021|