Validation routine with standard test protocol

VALIDATION

Validation routine with
standard test protocol

D4InfoNet can be validated against all international standards and guidelines. It is, among others, relevant to manufacturers of medical devices and pharmaceuticals.

The validation package

- We support our customers’ validation activities, whether they comply with EU GMP or FDA regulations.
- We implement procedures and risk-based test cases to provide adequate documentation for IQ and OQ.
- Our approach covers the rules of pharmaceutical products (FDA and EU-GxP) and medical devices.
- Support for regulated customers also covers proper documentation and evaluation of any change that the customer requires after the validation.
- We provide a complete support package for the customer’s validation activities, consisting of a qualification plan, IQ and OQ test protocols and a qualification report.
- We provide a manageable, user-friendly and time-saving solution.
- We help our customers in making their validation process more manageable and flexible.
- Our customers can save time and focus on their business.

"When Heka Dental A/S needed to invest in a digital platform, the choice fell on D4InfoNet because it is a simple and user-friendly system that can also validate the company’s software. “We were given a good offer on a standard solution that was most suitable for us,”

Claus van der Goot, quality manager

"The test protocol is the most important thing to have in place when IT systems and software are to be validated. Vitrex Medical A/S uses D4InfoNet’s standard version. “It describes in detail what to check and test, and it also describes the expected result. And then it’s just about verifying that it matches reality,”

D4 itself is certified in DS/EN ISO 9001:2015 AND DS/EN ISO/IEC 27001:2017

These two standards stands for quality and information security – two elements we value highly. Whether it is about our management system, applications, development or service.