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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 Agreement, Change control, Claim & Deviation with CAPA, Document management, Dossier Management MedTech, Dossier Management Pharma, SOP, Supplier Management and Training Management.

InfoTech Scandinavia can also assist by helping to carry out certain tasks of the validation such as to complete the Installation Qualification Protocol & Report and perform the tests in the Operational Qualification Protocol & Report 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 & Report
  • Operational Qualification Protocol & Report
  • Performance Qualification Protocol & Report
  • Deviation Log
  • Deviation Form
  • Requirement Traceability Matrix
  • Configuration Items List
  • Risk Assessment
  • Validation Plan
  • Validation Report

Operation

Advantum can either be installed in your server environment, in the cloud, or you can let us take care of the operation of Advantum in a strictly controlled server environment (Advantum ASP-service). Get in touch and we'll help you find the best operating solution!

READ MORE ABOUT ADVANTUM ASP-SERVICE

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Advantum is thoroughly tested and evaluated by

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5 STRONG ARGUMENTS

The user-friendly and flexible choice for information management

Plug & Play

We have developed Advantum into a system that is as close to Plug & Play as possible. If you don't want to make any changes to our finished ones pre-configurations, it's just a matter of getting started immediately, quickly and easily!

Anywhere

Being able to work from anywhere you want is entirely natural today. That's why Advantum is developed to function as well on your smartphone and tablet as on your computer.

Truly flexible

With Advantum's extreme flexibility, you can take on the challenges of today staying prepared for future needs and requirements for technical and organisational changes.

Flexible Licenses

Advantum is a flexible system, as is our licensing model! We use flexible licensing and focus on the number of concurrent users in the system. By sharing licenses, Advantum becomes a cost-efficient choice for you.

Personal Advisor

Our customers appreciated our support the most. As our customer, you can always contact your own personal advisor for easy and efficient handling of all your questions and issues.

Konfigurera Anpassa dokumenthanteringssystem
Flexible Licenses

Should you configure or customize
 the document management system?

One of the strengths Advantum has is extreme flexibility combined with it being a standard software product. This combination means you can have management that matches your needs and requirements without needing to develop a custom solution.
Configuration
Configuration means achieving the management you're looking for with the help of standard components. No new functionality needs to be developed, instead the components are so flexible they can be configured to look and function as you want. The system can be easily kept up-to-date by using our latest version without any specific consulting.
Customization
Customization means creating a system unique to a customer with functions that need to be maintained and updated separately for each individual customer. The functionality is not tried or tested and the costly work of keeping customer-specific systems updated often leaves further development under-invested or left out altogether.

Why we advocate configuration
 instead of customization

Through the years, we have learned that the needs of our customers are often very different from one another. We have addressed this by offering the same system to everyone. Does that sound strange? It’s easy! What we do is simply configure the system to look and function according to your needs and requirements. This means that all of our customers have the same system, but that they often look and function in entirely different ways.

Why is the difference between configuration and customization
 so important?

When you adapt a system, you create something unique for a customer which then needs to be maintained in an equally unique way. A configurable standard system can be maintained through common maintenance and is therefore much more cost efficient.