Validation starter package

When a system needs to be validated, it can be difficult to know where to start and it can also take a lot of time. Validation is something that is performed to ensure that the system meets the requirements set and that it meets the intended use set by the business.

The Advantum Validation starter package is a standard package that contains a set of documents required to perform a validation of Advantum pre-configurations. Since many of the documents are written, it is possible to quickly get started and begin the work with the validation such as e.g. execute the test cases that exist. In the documents where information is required to be written, there are guiding instructions regarding what should be written under each part.

Advantum Validation starter package can be combined with the following pre-configurations: Contract, Document management, Dossier management MedTech, Dossier management pharma, Supplier management, Claim & deviation with CAPA, Training management and Change control.

InfoTech Scandinavia can also assist by helping to carry out certain tasks of the validation such as to complete the Installation qualification protocol and perform the tests in the Operational qualification protocol or act as a sounding board.

Documents that are included in Advantum Validation starter package:

• User requirement specification
• System requirement specification
• Configuration specification
• Installation qualification protocol
• Operational qualification protocol
• Performance qualification protocol
• Test report
• Deviation log
• Deviation form
• Requirement traceability matrix
• Risk assessment
• Validation plan
• Validation report